Data/hora: 03/06/2024 10:09:04

Provedor de dados: | 60
País: | Brazil
Título: | Sensitive spectrophotometric assay of simvastatin in pharmaceuticals using permanganate
Autores: | Tharpa,Kalsang; Basavaiah,Kanakapura; Rajedraprasad,Nagaraju; Vinay,Kanakapura Basavaiah; Hiriyanna,Salmara Ganeshbhat.
Data: | 2010-03-01
Ano: | 2010
Palavras-chave: | Simvastatin assay; Spectrophotometry; Permanganate; Pharmaceutical products.
Resumo: | Two simple, sensitive, selective and inexpensive spectrophotometric methods are described for the determination of simvastatin (SMT) in bulk drug and in tablets using permanganate as the oxidimetric reagent. In method A, SMT is treated with a measured excess of permanganate in acetic acid medium and the unreacted oxidant is measured at 550 nm, whereas in method B the reaction is carried out in alkaline medium and the resulting manganate is measured at 610 nm. In method A, the amount of permanganate reacted corresponds to the SMT content and the absorbance is found to decrease linearly with the concentration; and in method B, the absorbance increases with concentration. The working conditions of assays were optimized, and the methods were validated according to the current ICH guidelines. Under optimum conditions, SMT could be assayed in the concentration ranges, 1.47 - 17.67x10-5 and 2.27 - 27.18 x10-6 mol/L by method A and method B, respectively. The calculated molar absorptivities are 3.2 x 10³ and 2.5 x 10(4) L/mol/cm for method A and method B, respectively with corresponding Sandell sensitivity values of 0.0387 and 0.0178 μg/cm². The limits of detection (LOD) and quantification (LOQ) have also been reported. Accuracy and precision for the assay were determined by calculating the intra-day and inter-day at three concentrations; the intra-day RSD was &lt; 2% and the accuracy was better than 2.15 % (RE). The methods were applied successfully for the determination of SMT in tablet dosage form with a high percentage of recovery, good accuracy and precision, and without measurable interference by the excipients. The accuracy was further ascertained from placebo and synthetic mixture analysis and also from the spike-recovery method.
Tipo: | Info:eu-repo/semantics/article
Idioma: | Inglês
Identificador: | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502010000100010
Editor: | Universidade de São Paulo, Faculdade de Ciências Farmacêuticas
Relação: | 10.1590/S1984-82502010000100010
Formato: | text/html
Fonte: | Brazilian Journal of Pharmaceutical Sciences  v.46 n.1 2010
Fonte: | info:eu-repo/semantics/openAccess