formulation and characterizatin of transdermal

Krunali Thakkar et al. / International Journal of Advances in Pharmaceutical Research

IJAPR Available Online through www.ijapronline.org

Review Article ISSN: 2230 – 7583

RECENT ADVANCES IN HERBAL DRUG STANDARDIZATION – A REVIEW Krunali Thakkar1*, Vijya Parmar1, Dhara Patel1, Dhananjay Meshram1 Department of Quality Assurance, Pioneer Pharmacy Degree College, Vadodara-390019, Gujarat, India Received on 10 – 05 - 2013

Revised on 23 – 06- 2013

Accepted on 27– 07 – 2013

ABSTRACT Recently peoples are getting attracted towards herbal medicines due to many advantages. Herbal formulations have reached extensive acceptability as therapeutic agents for several diseases. Although, most of these applications are unorthodox, it is however a known fact that over 80% of the world population depends on herbal medicines and product for healthy living. This rise in the use of herbal product has also given rise to various forms of abuse and adulteration of the products leading to consumers’ and manufacturers’ disappointment and in some instances fatal consequences. The development of authentic analytical methods which can reliably profile the phytochemical composition, including quantitative analyses of marker/bioactive compounds and other major constituents, is a major challenge to scientists. Standardization is an important step for the establishment of a consistent biological activity, a consistent chemical profile, or simply a quality assurance program for production and manufacturing of herbal drugs. In present review article various convectional methods as well as newer advances are described. Recent advancements includes DNA fingerprinting, metabolomics technique, differintial pulse polarography, chemometric, X-ray diffraction…etc are observed. Capillary electrophoresis and chromatographictechniques contributions towards standardization of herbal drugs is also reported. Key Words: Standardization, herbal drug, DNA fingerprinting, chromatographic techniques INTRODUCTION[1-5] The use of herbs as medicine is the oldest form of healthcare known to humanity and has been used in all cultures throughout history.[1] Herbal drugs have been used since ancient times as medicines for the treatment of a range of diseases. Medicinal plants have played a key role in world health. In spite of the great advances observed in modern medicine in recent decades, plants still make an important contribution to health care.[2] *Author for Corrrespondence Krunali Thakkar Department of quality assurance Pioneer Pharmacy Degree College Email Id: [email protected] Mobile No: 9979081008

There are at least 120 distinct chemical substances derived from plants that are considered as important drugs currently in use in the world, while several other drugs are simple synthetic modifications of the natural products.[3] Herbs include crude plant material, such as leaves, flowers, fruit, seeds, stems, wood, bark, roots, rhizomes or other plant parts, which may be entire, fragmented or powdered. Herbal materials include, in addition to herbs, fresh juices, gums, fixed oils, essential oils, resins and dry powders of herbs. In some countries, these materials may be processed by various local procedures, such as steaming, roasting or stir-baking with honey, alcoholic beverages or other materials. Herbal preparations are the basis for finished herbal products and may include comminuted or powdered herbal materials, or extracts, tinctures and fatty oils of herbal materials. They are produced by extraction, fractionation, purification, concentration, or other physical or biological processes. They also include

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Krunali Thakkar et al. / International Journal of Advances in Pharmaceutical Research preparations made by steeping or heating herbal materials in alcoholic beverages and/or honey, or in other materials.[4] Herbs include crude plant material, such as leaves, flowers, fruit, seeds, stems, wood, bark, roots, rhizomes or other plant parts, which may be entire, fragmented or powdered. Herbal materials include, in addition to herbs, fresh juices, gums, fixed oils, essential oils, resins and dry powders of herbs. In some countries, these materials may be processed by various local procedures, such as steaming, roasting or stir-baking with honey, alcoholic beverages or other materials. Herbal preparations are the basis for finished herbal products and may include comminuted or powdered herbal materials, or extracts, tinctures and fatty oils of herbal materials. They are produced by extraction, fractionation, purification, concentration, or other physical or biological processes. They also include preparations made by steeping or heating herbal materials in alcoholic beverages and/or honey, or in other materials. Finished herbal products consist of herbal preparations made from one or more herbs. If more than one herb is used, the term “mixture herbal product” can also be used. Finished herbal products and mixture herbal products may contain excipients in addition to the active ingredients. However, finished products or mixture herbal products to which chemically defined active substances have been added, including synthetic compounds and/or isolated constituents from herbal materials, are not considered to be herbal (WHO guideline, 2000).[5] CONCEPT OF STANDARDIZATION[6-8] Standardization of herbal medicines is the process of prescribing a set of standards or inherent characteristics, constant parameters, definitive qualitative and quantitative values that carry an assurance of quality, efficacy, safety and reproducibility. It is the process of developing and agreeing upon technical standards. Specific standards are worked out by experimentation and observations, which would lead to the process of prescribing a set of characteristics exhibited by the particular herbal medicine. Hence standardization is a tool in the quality control process.[6-7] The authentication of herbal drugs and identification of adulterants from genuine medicinal herbs are essential for both pharmaceutical companies a swell as public health and to ensure reproducible quality of herbal medicine.[8] STANDARDIZATION OF HERBAL FORMULATION [9-12] Standardization of herbal formulation requires implementation of Good Manufacturing

Practices(GMP).[9-10] In addition, study of various parameters such as pharmacodynamics, pharmacokinetics, dosage, stability, self-life, toxicity evaluation, chemical profiling o f the herbal formulations is considered essential.[11] Other factors such as pesticides residue, aflatoxine content, heavy metals contamination, Good Agricultural Practices (GAP) in herbal drug standardization are equally important.[12] STANDARDIZATION OF POLYHERBAL FORMULATION[13-17] Standardization is an important aspect for maintaining and assessing the quality and safety of the polyherbal formulation as these are combinations of more than one herb to attain the desire therapeutic effect[13] . Standardization minimizes batch to batch variation; assure safety, efficacy, quality and acceptability of the polyherbal formulations[14] . The standardization of various marketed herbal and polyherbal formulation Madhumehari Churna (Baidynath) containing the mixture of eight herbal.[15]. Dashamularishta, a traditional formulation, used in the normalization of physiological processes after child birth.[16] TLC and HPTLC fingerprint profiles were used for deciding the identity, purityand strength of the polyherbal formulation and also for fixing standards for this Ayurvedic formulation. [17] STANDARDIZATION AND QUALITY CONTROL OF HERBAL CRUDE DRUGS – PARAMETERS [18-20] According to WHO (1996a and b, 1992), standardization and quality control of herbals is the process involved in the physicochemical evaluation of crude drug covering aspects, such as selection and handling of crude material, safety, efficacy and stability assessment of finished product, documentation of safety and risk based on experience, provision of product information to consumer and product promotion. Attention is normally paid to such quality indices such as: Morphology and organoleptic evaluation: In case of whole drug morphological characters are important for differentiating purpose. It mainly includes colour, odour, taste, shape, size etc. Detail characteristics includes fractures, texture, venation etc Microscopic and histologic evaluation: These are valuable in both whole as well as powdered drug. It mainly includes study of characteristics like parenchyma, trichomes, calcium oxalate crystals, vascular bundle arrangements, stomata, fibres etc. Qunatitative microscopic study: Microscopic determination such as vein islet number, stomatal index, stomatal number, vein termination number,


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size of fibres, palisade ratio. Such study helps in differentiation of closely allied species. Physical evaluation: study of various physical parameters like moisture content, solubility, viscosity, refractive index, melting point, optical rotation, ash values, extractives and foreign organic matter. Qualitative chemical evaluation: This covers identification and characterization of crude drug with respect to phytochemical constituent. It employs different analytical technique to detect and isolate the active constituents. Phytochemical screening techniques involve botanical identification, extraction with suitable solvents, purification, and characterization of the active constituents of pharmaceutical importance Quantitative chemical evaluation: To estimate the amount of the major classes of constituents. Toxicological studies: This helps to determine the pesticide residues, potentially toxic elements, safety studies in animals like LD50 and Microbial assay to establish the absence or presence of potentially harmful microorganisms. Microbiological parameters: It includes the full content of viable, total mould count, total coliforms count. Limiters can be used as a quantitative tool or semi-quantitative to determine and control the amount of impurities, such as reagents used in the extraction of various herbs, impurities ships directly from the manufacturing and solvents etc. [18-20] CONVECTIONAL METHOD FOR STANDARDIZATION OF HERBAL DRUG FORMULATION 1.THIN LAYER CHROMATOGRAPHY (TLC) [21-22]

TLC is one of the most popular and simple chromatographic technique used of separation of compounds. In the phytochemical evaluation of herbal drugs, TLC is the common fingerprint technique for herbal analysis. The herbal compounds can easily identified by TLC [21]. In this technique, the authentication of various species, evaluation of stability and consistency of their preparations from different manufacturers TLC is being employed extensively for the following reasons: 1.It enables rapid analysis of herbal extracts with minimum sample clean-up requirement, 2. It provides qualitative and semi quantitative information of the resolved compounds. 3. It enables the quantification of chemical constituents [22] HIGH PERFORMANCE THIN LAYER CHROMATOGRAPHY (HPTLC)[23-28] HPTLC is the common fingerprint mainly used to analyze the compounds which is having low or

moderate polarities. HPTLC technique is widely used in the pharmaceutical industry for process development, identification and detection of adulterants, substituent in the herbal products and also helps in the identification of pesticide content, mycotoxins and in quality control of herb and health products [23]. HPTLC technique was reported for simultaneous estimation of gallic acid, Rutin, Quercetin in terminalia chebula.[24] Syzygium Jambolanum was quantitativelyevaluated in terms of stability, repeatability, accuracy and phyto constituents such as glycoside (jamboline),tannin, ellagic acid and gallic acid by HPTLC[25] It was also used for detection, monitoring and quantification of bacoside A & B in Bacopa monnieria and its formulation.[26] Also HPTLC method for phyto constituents in crude drugs or herbal formulations such as bergenin, catechine and gallic acid in Bergenia cilliata and Bergenia lingulata.[27] Chandanasava known to be effective in karsya (malnutrition) was standardised by organoleptic study, physico-chemical analysis, TLC and HPTLC. [28]

GAS CHROMATOGRAPHY [29] Gas chromatography (GC), also known as gas liquid chromatography (GLC), is a technique for separation of mixtures into components by a process which depends on the redistribution of the components between a stationary phase or support material in the form of a liquid, solid or combination of both and a gaseous mobile phase. It is well-known that many pharmacologically active components in herbal medicines are volatile chemical compounds. Thus, the analysis of volatile compounds by gas chromatography is very important in the analysis of herbal medicines. The GC analysis of the volatile oils has a number of advantages. Firstly, the GC of the volatile oil gives a reasonable “fingerprint” which can be used to identify the plant. The composition and relative concentration of the organic compounds in the volatile oil are characteristic of the particular plant and the presence of impurities in the volatile oil can be readily detected. Secondly, the extraction of the volatile oil is relatively straightforward and can be standardized and the components can be readily identified using GC-MS analysis.[29] HIGH PERFORMANCE LIQUID CHROMATOGRAPHY [30-34] HPLC is a popular method for the analysis of herbal medicines because it is easy to learn and use and is not limited by the volatility or stability of the sample compound. In general, HPLC can be used to analyze almost all the compounds in the herbal medicines. Thus, over the past decades, HPLC


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has received the most extensive application in the analysis of herbal medicines. Reversed-phase (RP) columns may be the most popular columns used in the analytical separation of herbal medicines. It is necessary to notice that the optimal separation condition for the HPLC involves many factors, such as the different compositions of the mobile phases, their pH adjustment, pump pressures, etcThus, a good experimental design for the optimal separation seems in general necessary.[30] In order to obtain better separation, some new techniques have been recently developed in research field of liquid chromatography. These are micellar electrokinetic capillary chromatography (MECC), high-speed countercurrent chromatography (HSCCC), low-pressure size-exclusion chromatography (SEC), reversedphase ion-pairing HPLC (RPIPC-HPLC), and strong anion-exchange HPLC (SAX-HPLC). They will provide new opportunities for good separation for some specific extracts of some herbal medicines. On the other hand, the advantages of HPLC lie in its versatility for the analysis of the chemical compounds in herbal medicines, however, the commonly used detector in HPLC, say single wavelength UV detector, seems to be unable to fulfill the task, since lots of chemical compounds in herbal medicines are non-chromophoric compounds. Consequently, a marked increase in the use of HPLC analysis coupled with evaporative light scattering detection (ELSD) in a recent decade demonstrated that ELSD is an excellent detection method for the analysis of non-chromophoric compounds. This new detector provides a possibility for the direct HPLC analysis of many pharmacologically active components in herbal medicines, since the response of ELSD depends only on the size, shape, and number of eluate particles rather than the analysis structure and/or chromophore of analytes as UV detector do. Especially, this technique is quite suitable for the construction of the fingerprints of the herbal medicines. Moreover, the qualitative analysis or structure elucidation of the chemical components in herbal drug by simple HPLC is not possible, as they rely on the application of techniques using hyphenated HPLC, such as HPLC-IR, HPLC–MS, HPLC-NMR, for the analysis of herbal medicines. [3134]

SUPER CRITICAL FLUID CHROMATOGRAPHY (SFC) [35-36] Supercritical fluid chromatography is a hybrid of gas and liquid chromatography that combines some of the best features of each. SFC permits the separation and determination of a group of compounds that are not conveniently handled by either gas or

liquid chromatography. SFC has been applied to a wide variety of materials including natural products, drugs, food and pesticide. [35]. These compounds are either nonvolatile or thermally labile so that GC procedures are inapplicable or contain no functional group that makes possible detection by the spectroscopic or electrochemical technique employed in LC.[36] INFRARED SPECTROSCOPY [37-41] Near-infrared spectroscopy technique has been used for rapid determination of active components, species, geographic origin, special medicinal formula, on-line quality Control ,identification of counterfeit and discrimination of geographical origins of Chinese herbal medicines.[37-39] Two-dimensional nearinfrared (NIR) correlation Spectroscop ywas applied to the discrimination of Fructus lycii (a traditional Chinese medicinal herb)of four different geographic regions. [40] FTIR along with the statistical method principal component analysis (PCA) was applied to identify and discriminate herbal medicines for quality control in the fingerprint region 400-2000 cm-1. The ratio of the areas of any two marked characteristic peaks was found to be nearly consistent for the same plant from different regions, thereby, an additional discrimination method for herbal medicines. PCA clusters herbal medicines into different groups, clearly showing that IR method can adequately discriminate different herbal medicines using FTIR data.[41] ELECTROPHORETIC METHODS [42-43] Most of the used techniques are capillary zone electrophoresis (CZE), capillary gel electrophoresis (CGE) and capillary isoelectric focusing (CIEF). CE is promising for the separation and analysis of active ingredients in herbal medicines, since it needs only small amounts of standards and can analyze samples rapidly with very good separation ability. Also, it is a good tool for producing the chemical fingerprints of the herbal medicines, since it has similar technical characteristics of liquid chromatography. Recently, several studies dealing with herbal medicines have been reported and two kinds of medicinal compounds, i.e. alkaloids and flavonoids, have been studied [42-43] NEWER METHODS FOR STANDARDIZATION OF HERBAL DRUGS DNA FINGERPRINTING TECHNIQUE [44-49] DNA analysis has been proved as an important tool in herbal drug standardization. This technique is useful for the identification of phytochemically indistinguishable genuine drug from substituted or adulterated drug. It has been reported that DNA fingerprint genome remain the same irrespective of


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Krunali Thakkar et al. / International Journal of Advances in Pharmaceutical Research the plant part used while the phytochemical content will vary with the plant part used, physiology and environment.[44] Deoxyribonucleic acid (DNA) is the fundamental building component of all living cells. Our characteristics, traits and physical features are determined by the specific arrangement of DNA base-pair sequences in the cell. It is this distinct arrangement of adenine, guanine, thymine and cytosine (called DNA nucleotides) that regulates the production of specific proteins and enzymes via the Central Dogma Theory. Central Dogma theory can be defined as the fundamental theory of molecular biology that genetic information flows from DNA to RNA to proteins.[45]Genotypic characterization of plant species and strains is useful as most plants, though belonging to the same genus and species, may show considerable variation between strains. Additional motivation for using DNA fingerprinting on commercial herbal drugs is the availability of intact genomic DNA from plant samples after they are processed. Adulterants can be distinguished even in processed samples, enabling the authentication of the drug. [46] Inter-Simple Sequence Repeat (ISSR) a PCR-based application is unique and inexpensive popular technique of DNA finger printing which include the characterization of genetic fingerprinting, gene tagging, detection of clonal variation, phylogenetic analysis, detection of genomic instability, and assessment of hybridization.[29]Cannabis sativa and Arabidopsis thaliana L. Heyne have been differentiated from their adulterated species by using ISSR markers.[47]DNA based molecular markers have been found to be useful in differentiating different accessions of Taxus wallichiana, Azarchdichta indica, Juniperus communis L., Codonopsis pilosula ,Allium schoenoprasum L., Andrographis paniculata collected from different geographical regions. [48-49] CHEMOMETRIC METHODS [50-51] Chemo metrics is a statistical approach to analyze instrument data, chemometrics often results in a faster and more precise Assessment of composition of a product or even physical or sensory properties. For example, composition (fat, fiber, moisture, carbohydrate) of dairy products or grain can be quickly measured using near infrared spectroscopy and chemometrics. Food properties (e.g., taste, smell, astringency) can also be monitored on a continuous basis. The two general applications of chemometrics technology to predict a property of interest and to classify the sample into one of several categories (e.g., good versus bad, Type A versus Type B versus Type C etc.). Chemometrics is designed to recognize patterns in virtually any type of

multidimensional analytical data. Chemometrics can be used to speed methods development and make routine the use of statistical models for data analysis. Keeping in view of the complexity of the chromatographic fingerprint and the irreproducibility of chromatographic and spectral instruments and experimental conditions, several chemometric approaches such as variance analysis, peak alignment, correlation analysis and pattern recognition were employed to deal with the chromatographic fingerprint. The basic principles for this approach are variation determination of common peaks/ regions and similarity comparison with similarity index and linear correlation coefficient. To facilitate the data processing, software named Computer Aided Similarity Evaluation (CASE) has been developed. All programs of chemometric algorithms for CASE are coded in METLAB5.3 based on windows. Data loading, removing, cutting, smoothing, compressing, background and retention time shift correction, normalization, peak identification and spectral matching, variation determination of common peaks/regions, similarity comparison, overly of sample classification and other data processes associated with the chromatographic fingerprint can be investigated with this software. [5051]

METABOLOMIC TECHNIQUES [52-55] Metabolomics is a advanced emerging field of 'omics' research that is concerned with characterizing large numbers of metabolites using NMR, chromatography and mass spectrometry. It is comanly used in biomarker identification and the metabolic profiling of cells, tissues or organisms. The data processing challenges in this technique are quite unique and often require specialized (or expensive) data analysis software.Metabolomics has been used for identification of active phytoconstituents from herbal medicine. [52]Metabolomic approach was employed to identify the chemical constituentsin Sophora flavescens, which were further analyzed for their effect on Pregane X receptor activation and Cytochrome P3A regulation. The greater potential of metabolomics has been reported in the development of active secondary metabolites from medicinal plants as novel or improved phytotherapeutic agents.[53-54] The recent studies showed that NMRbased metabolomics approach combined with orthogonal projections to latent structurediscriminant analysis identified the purity of an herbal medicine.[55] DIFFERINTIAL PULSE POLAROGRAPHY (DPP) [56-61] DPP can be used to study trace amounts of chemicalswith very small detection limits on the


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order of 10-8 M. Some heavy metals, including lead, cadmium, zinc, copper and iron were successfully identified and determined in chamomile and calendulea flowers by DPP [56-57] Accumulation of heavy metals,namely Pb, Cd, Cu and Zn was estimated in marketed as well as genuine samples of important herbal drugs of India viz., Alpinia galanga, Artemesia parviflora, Butea monosperrma, Curcuma amada, Euphorbia prostrate, , Malaxis accuminata etc. The concentration of Pb and Cd was found beyond the WHO permissiblelimits in most samples [58] Trace amounts of selenium in Chinese herbal medicines [59]and flavonoids in small amount of medicinal herb samples were determined byDPP[60]. A DPP method has been for the determination of total hypericin in phytotherapeutic preparations in various buffer systems over the pH range 3.5–10.0 [61] X-RAY POWDER DIFFRACTROMETRY (XRPD)[62-65] This technique is used to identify minerals, crystalline materials and metallic based herbal formulations. The tin based herbal drug Vanga Parpam was estimated by XRD and the intense sharp diffraction peaks clearly confirmed the presence of high crystallinity in Vanga Parpam[62] XRD analysis of metallic based Indian traditionally medicine Rassindoor indicated the presence of mercury sulphide which is represented by sharp peak[63]X-ray powder diffractometry data confirmed the formation of phospholipid complex with emodin, naringenin, quercetin , gallic acid.[64-65] THERMAL ANALYSIS [66-70] Thermogravimetric analysis (TGA), differential thermal analysis (DTA) and differential scanning calorimetry (DSC) have been Used to study diffirent physical or chemical changes in various products including herbal drugs and also used to study preformulation or drug excipient compatibility. [66] TGA may be operated under subambient conditions to analyse alcoholic content in various herbal formulations such as asavas and arista1. [67] TGA and DTA Analystical method are used to determine mercury based Indian traditional metallic herbal drug Ras-sindoor indicated the presence of mercury sulphide based on a sharp peak at 354oC which corresponded to melting temperature of mercury sulphide1.[68] It is also used in determination of metals present in Bhasma. The optimized extraction obtained by distillation showed the presence of volatile oil in dry ginger as a component of volatile oil-beta-cyclodextrin inclusion compound using DTA technology .[69] DSC thermograms data confirmed the formation of phospholipid complex with emodin (an anthraquinone).[70-71] MASS SPECTROSCOPY [72-75]

Recent advances includes electrospray, thermospray, and ionspray ionization techniques which offer unique advantages of high detection sensitivity and specificity, liquid secondary ion mass spectroscopy, later laser mass spectroscopy with 600 MHz offers accurate determination of molecular weight proteins, peptides. Isotopes pattern can be detected by this technique.[72] LC-MS has become method of choice in many stages of drug development [73]Chemical standardization of an aqueous extract of the mixture of the 20 herbs provided 20 chemical compounds serving as reference markers using LC-MS [74] Further, LC-MS analysis of aminoglycosides showed that these drugs are highly soluble in water, exhibited low plasma protein binding, and were more than 90% excreted through the kidney. Further this technique helps in analysis of aminoglycosides in plasma samples with ion pairing chromatography. [75] NUCLEAR MAGNETIC RESONANCE [76-77] The recent introduction of pulsed field gradient technique in high resolution NMR as well as threedimensional technique improves application in structure elucidation and molecular weight information. These new hyphenated techniques are useful in the areas of pharmacokinetics, toxicity studies, drug metabolism and drug discovery process.[76] The combination of chromatographic separation technique with NMR spectroscopy is one of the most powerful and time saving method for the separation and structural elucidation of unknown compound and mixtures, especially for the structure elucidation of light and oxygen sensitive substances.[77] CONCLUSION In recent years, plant derived products are increasingly being sought out as medicinal products, nutraceuticals and cosmetics and are available in health food shops and pharmacies over the counter as selfmedication or also as drugs prescribed in the nonallopathic systems. Herbals are traditionally considered harmless and increasingly being consumed by people without prescription.Quality evaluation of herbal preparation is a fundamental requirement of industry and other organization dealing with ayurvedic and herbal products.The traditional approach towards standardization is insufficient for current herbal market and hence there is need for more advanced techniques for standardization. There are basically two techniques used for standardization these are chromatographic fingerprinting and DNA fingerprinting. The chromatographic fingerprinting is based on the chromatographic separation and identification of marker compound from other constituents. For these


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INTERNATIONAL CONGRESS IN PHARMACY AND HEALTH SCIENCES Pharma Science Tech Association, Foundation No: AP/PSTA/56/2012. Please visit for Details: www.icphsmembership.com Totally three types FICPHS (Fellowship in International Congress in Pharmacy and Health Sciences), MICPHS (Member in International Congress in Pharmacy and Health Sciences), AMICPHS (Associate Member in International Congress in Pharmacy And Health Sciences) Eligibility FICPHS: Ph.D in Chemistry/ Pharmacy / M.Sc / M.Pharm with 2 years experience, MICPHS: M.Sc / M.Pharm (or) B.Sc / B.Pharm with 2 years experience, AMICPHS: B.Sc (or) B.Pharmacy


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