8013 Souza

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(250 ´ 4.6 mm id, 5 mm particle size) column from Merck. ([ADD CITY OF ..... (1) The Merck Index (2001) 13th Ed., Whitehouse Station, NJ. (2) Deshpande, L.
SOUZA ET AL.: JOURNAL OF AOAC INTERNATIONAL VOL. 92, NO. 6, 2009 1 DRUG FORMULATIONS AND CLINICAL METHODS

Development of a Ultraviolet Spectrophotometric Method for the Determination of Ceftiofur Sodium Powder MARINÊS J.E. SOUZA Universidade Federal do Rio Grande do Sul (UFRGS), Faculdade de Farmácia, Programa de Pós-Graduação em Ciências Farmacêuticas, Porto Alegre, RS, Brazil; Agência Nacional de Vigilância Sanitária (ANVISA), Brasília – DF, Brazil NATÁLIA A.P. CANEDO UFRGS, Faculdade de Farmácia, Porto Alegre, RS, Brazil PAULO S. SOUZA FILHO Universidade Federal de Santa Maria, Programa de Pós-graduação em Engenharia Agrícola, Santa Maria, RS, Brazil ANA M. BERGOLD UFRGS, Faculdade de Farmácia, Programa de Pós-Graduação em Ciências Farmacêuticas, Porto Alegre, RS, Brazil

A UV spectrophotometric method was developed for determination of ceftiofur sodium in the drug substance and sterile powder for injection. The method validation, which yielded good results, included evaluation of the range, linearity, intraand interday precision, accuracy, recovery, specificity, robustness, LOQ, and LOD. The UV spectrophotometric determinations were performed at 292 nm. Good linearity was obtained between 2.5 and 20.0 mg/mL. A prospective validation showed that the method is linear (r = 0.9999) and precise, with RSD values of 0.3% for product A and 0.4% for product B. The intraand interday precision values were