simple uv spectrophotometric assay of rosuvastatin

The Global Journal of Pharmaceutical Research Vol. 3 (3), pp. 1985-90, Sep, 2014; www.tgjpr.com

FULL LENGTH RESEARCH ARTICLE

ISSN 2277-5439

SIMPLE UV SPECTROPHOTOMETRIC ASSAY OF ROSUVASTATIN FORMULATIONS *Safila Naveed, Fatima Qamar Faculty of Pharmacy, Jinnah University for women, Karachi, Pakistan *Corresponding E-mail: [email protected] st

Accepted 1 Sep, 2014

Rosuvastatin belongs to statin family. It is being used widely for the treatment of dislipidaemia. An efficient least time consuming and simple spectrophotometric method for the assay of rosuvastatin has been developed. Comparison of assay of five different brands of rosuvastatin (Rosulin, Rosubar, xplended, Rovita, Rovactor) has also been done available in public medical store of Karachi, Pakistan. The assasy is based on the ultraviolet UV absorbance maxima at about 243nm wavelength of rosuvastatin using water as solvent. A sample of drug was dissolved in water to produce a solution containing rosuvastatin. Similarly, a sample of ground tablets of different brand were dissolved in water and various dilutions were made. The absorbance of sample preparation was measured at 244nm against the solvent blank and the assay was determined by comparing with the absorbance of available brand. Our results reveal that among all the five brands of rosuvastatin (Rosulin, Rosubar, xplended, Rovista, Rovactor) rosulin and rovista shows highest percentage assay 107.5%. Xplended and rosubar shows percent assay of 106.25% and 103.75% while rovactor shows lowest value for percentage assay 98.75%. KEYWORDS: Rosuvastatin, Assay, UV Spectrophotometric INTRODUCTION Rosuvastatin is a synthetic statin. It shows an advance in clinical and pharmacologic properties of statins. Comparatively to other statins, it possesses a greater number of binding interactions with 3-hydroxy-3methylglutaryl coenzyme A ( HMGCoA) reductase and has a greater affinity for the enzyme active site. Rosuvastatin is comparatively more hydrophilic. It is active in and selectively taken up by hepatic cells.

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Among all statin rosuvastatin shows the longest terminal half-life. Only small amount is metabolized by the enzyme system cytochrome P450 (CYP 450), without considerable involvement of the enzyme 3A4. There is no clinically significant drug interactions between other drugs and rosuvastatin to inhibit enzyme CYP 450 1,2. Rosuvastatin eliminates primarily through liver. Metabolism shows to be a minor route of clearance3. Rosuvastatin is an inhibitor of HMG-CoA reductase. This reductase enzyme is the rate-limiting 1985


enzyme in cholesterol biosynthesis. It is effective for the treatment of dyslipidaemia. Clinical trials show that rosuvastatin 1-80 mg produced highly considerable dose-dependent reductions in low-density lipoprotein (LDL) cholesterol up to 65% and it was well-tolerated 4. In our present study the aim of study was to calculate the percent assay of five different brands of rosuvastatin. An efficient least time consuming and simple spectrophotometric method for the assay of rosuvastatin has been developed. Comparison of assay of five different brands of rosuvastatin (Rosulin, Rosubar, xplended, Rovita, Rovactor) has also been done. EXPERIMENTAL UV visible 1601 Shimadzu double beam spectrophotometer was used to measurement of spectra. The solvent which are used for the assay was water. Wavelength Selection About 100 ppm of rosuvastatin solution was accurately prepared in water. The solutions were scanned in the 200-400 nm UV regions. The wavelength maxima (λ max) were observed at 244 nm and this wavelength was adopted for absorbance measurement. Standard Stock solution Accurately weighed 10 mg of rosuvastatin standard was transferred to a volumetric flask and add sufficient water to produce 100 ml. Sample Preparation The five different brands (Rosulin, Rosubar, xplended, Rovita, Naveed et al.

Rovactor) were purchased from different medical store in Karachi. The tablets of each brand have same batch number and were labeled to conatin rosuvastatin 10mg per tablet. All the five brands have 5 year shelf life. 20 tablets of five different brand of rosuvastatin (Rosulin, Rosubar, xplended, Rovita, Rovactor) from the marketed sample were weighed and crushed uniformly with the help of a mortar and pestle. By calculating the average weight of sample powder equivalent to 10 mg of rosuvastatin was transferred into a volumetric flask containing 10mL water. The solutions were sonicated for about 5 min and than make up volume up to 100 ml with water. Procedure After preparation of standard and tablet solutions, strength of solution 100 ppm in 100 ml absorbance of the sample preparation and standard preparation in 1cm cell at the wavelength of maximum absorbance at about 244 nm, using a spectrophotometer with the blank solution. Calculate the quantity in mg, of rosuvastatin per tablet. RESULTS AND DISCUSSION A survey of literature showed few UV spectrophotometric5-7 but these methods are not as sensitive like this because in these methods concentration is used not minimum as this method. Our research group has develop simple UV methods for different brands of different generics are also very sensitive least time consuming and simple 8-12. 1986


The absorbance of sample preparation was measured at 244nm against the solvent blank and the assay was determined by comparing with the absorbance of available brand. Our results reveals that among all the five brands of rosuvastatin (Rosulin, Rosubar, xplended, Rovista, Rovactor) rosulin and rovista shows highest percentage assay 107.5%. xplended and rosubar shows percent assay of 106.25% and 103.75% while rovactor shows lowest value for percentage assay 98.75%.This method is applicable for daily routine quantification of rosuvastatin. For calculation of percentage we use formula absorbance of sample divided by absorbance of standard and multiply by 100. % assay = Abs of sample (brands) /Abs of standard (active) *100 Pharmaceutical assay was carried out by using spectrophotometer on all brands of rosuvastatin (Rosulin, Rosubar, xplended, Rovista, Rovactor) tablets during the study. Table-1 shows name brand and % assay of different brands. Table-2, 3 are showing the descriptive within and between groups and shows results are highly significant with p value 0.000. Test of hypothesis i-e ANOVA and multiple comparison of different brands of rosuvastatin (Rosulin, Rosubar, xplended, Rovista, Rovactor) are given in table 3 shows highly significant difference of all brands with each other. The proposed method for the assay of commercially available rosuvastatin tablet formulation is very accurate, simple, rapid and least time consuming. It can be easily used for Naveed et al.

routine quality control QC for monitoring the assay in the API, inprocess samples and tablet formulation. ANOVA shows between and within group F value 174332.614 with degree of freedom df value 4 and 10 and p value 0.00 which shows significant results. But all brands have results within the range of USP/BP. REFRENCES 1. Rosenson RS. Rosuvastatin: a new inhibitor of HMG-coA reduc-tase for the treatment of dyslipidemia. Exp Rev Cardiovasc Ther. 2003;1:495–505. 2. McKenney JM. Efficacy and safety of rosuvastatin in treatment of dyslipidemia. Am J Health Syst Pharm.2005;62:1033–1047. 3. Steven G Simonson, Paul D Martin, Mike J Warwick, Patrick D Mitchell, and Dennis W Schneck The effect of rosuvastatin on oestrogen & progestin pharmacokinetics in healthy women taking an oral contraceptive Br J Clin Pharmacol. Mar 2004; 57(3): 279– 286.. 4. Olsson AG, Pears J, McKellar J, Mizan J, Raza A. Effect of rosuvastatin on lowdensity lipoprotein cholesterol in patients with hypercholesterolemia. Am J Cardiol. 2001;88:504–508. [PubMed] 5. Dhabale P.N., Gharge D.S., Simultaneous spectrophotometric estimation of atorvastatin and fenofibrate in bulk drug and dosage form,International Journal of ChemTech Research,2010, 2(1), 325-328. 6. Gupta K.R.,Askarkar S.S.,Rathod P.R.,Wadodkar S.G.,Validated spectro photometric determination of fenofibrate in formulation,Pelagia Research Library DerPharmacia Sinica,2010,1(1),173-178. 7. Gindy A.E.,Emara S.,Mesbah M.K.,Hadad G.M.,Spectrophotometric and liquid chromatographic determination of fenofibrate and vinpocetine and their hydrolysis products,I1farmaco,2005,3,425438. 8. Safila Naveed and Fatima Qamar (2014) Simple UV spectrophotometric assay of Mefenamic acid International Journal of Pharma Sciences and Research (IJPSR) ,5(7):364-366 .http://www.ijpsr.info/ijpsrv5n7.php 9. Safila Naveed and Fatima Qamar (2014) A simple assay of Esomeprazole Using UV spectrophotometer The Global Journal of Pharmaceutical Research (TGJPR) 3(2);

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.14(2):35-38. https://globaljournals.org/GJMR_Volume1 4/4-Simple-UV-SpectrophotometricAssay.pdf 12. Naveed Safila. Qamar Fatima., Sarwer Ghulam., (2014) Percentage assay of metformin in different medium using UVspectrophotometer BPJ0000130 - World Research Journal of Organic Chemistry Volume : 2 Issue : 1, 12-14 ISSN: 23203374 & E-ISSN: 2320-5679, http://www.bioinfopublication.org/jouarchiv e.php?opt=&jouid=BPJ0000130.

1921-25,http://www.tgjpr.com/view-article .php?id=3433. 10. Safila Naveed, Huda Kafeel and Ramsha Rukh (2014) Spectrophotometric method for the estimation of Ciprofloxacin in different medium. International Journal of Pharmaceutical Research & Drug Development1:1:27-30, www.ijprdd.orghttp://ijprdd.org/wpcontent/uploads/ 2014 /06/3 .pdf 11. Safila Naveed (2014) Simple UV spectrophotometric assay of Atorvastatin API formulation and their comparative study, Global Journal of Medical Research

Table 1: Percentage assay of different brands of Rosuvastatin Brand Name Rosulin Rosubar Xplended Rovista Rovactor

Average wt of tablet mg 0.15 0.14 0.19 0.19 0.18

Absorbance at 244 nm 0.086 0.083 0.085 0.086 0.079

Minimum Maximum Brand Name ASSAY Valid N (listwise)

Between Groups Within Groups Total

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1.00 98.74 -

5.00 107.50 -

Mean 3.0000 104.7413 -

Table 3:ANOVA Sum of df Mean Squares Square 162.710 4 40.678 0.002 10 0.000 162.713 14 -

% assay 107.5 103.75 106.25 107.5 98.75

Std. Deviation 1.46385 3.40916 -

F

Sig.

174332.614 0.000 -

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Table 4: Multiple Comparisons (I) Brand Name

(J) Brand Name

Mean Difference (I-J)

Std. Error

Rosubar 3.74333* 0.01247 * Xplended 1.24333 0.01247 Rosulin Rovista -0.01000 0.01247 * Rovactor 8.73333 0.01247 Rosulin -3.74333* 0.01247 -2.50000* 0.01247 Rosubar Xplended Rovista -3.75333* 0.01247 Rovactor 4.99000* 0.01247 * Rosulin -1.24333 0.01247 * 2.50000 0.01247 Xplended Rosubar * Rovista -1.25333 0.01247 Rovactor 7.49000* 0.01247 Rosulin 0.01000 0.01247 * Rosubar 3.75333 0.01247 Rovista Xplended 1.25333* 0.01247 * Rovactor 8.74333 0.01247 * Rosulin -8.73333 0.01247 * -4.99000 0.01247 Rovactor Rosubar Xplended -7.49000* 0.01247 Rovista -8.74333* 0.01247 *. The mean difference is significant at the 0.05 level.

Sig.

0.000 0.000 0.441 0.000 0.000 0.000 0.000 0.000 0.000 0.000 0.000 0.000 0.441 0.000 0.000 0.000 0.000 0.000 0.000 0.000

95% Confidence Interval Lower Upper Bound Bound 3.7155 3.7711 1.2155 1.2711 -0.0378 0.0178 8.7055 8.7611 -3.7711 -3.7155 -2.5278 -2.4722 -3.7811 -3.7255 4.9622 5.0178 -1.2711 -1.2155 2.4722 2.5278 -1.2811 -1.2255 7.4622 7.5178 -0.0178 0.0378 3.7255 3.7811 1.2255 1.2811 8.7155 8.7711 -8.7611 -8.7055 -5.0178 -4.9622 -7.5178 -7.4622 -8.7711 -8.7155

Fig. 1 Structure of Rosuvastatin

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Fig. 2 Percentage assay of different brands of Rosuvastatin

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