Sensitive spectrophotometric assay of simvastatin in pharmaceuticals using permanganate

Tharpa, Kalsang and Basavaiah, K. and Rajedraprasad, N. and Vinay, K. B. and Hiriyanna, S. G. (2010) Sensitive spectrophotometric assay of simvastatin in pharmaceuticals using permanganate. Brazilian Journal of Pharmaceutical Sciences, 46 (1). 91 - 98. ISSN 2175-9790

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Abstract

Two simple, sensitive, selective and inexpensive spectrophotometric methods arc 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 - 27.18x10(-6) mol/L by method A and method B, respectively. The calculated molar absorptivities are 3.2 x 10(3) 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 mu g/cm(2). 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 < 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.

Item Type:	Article
Subjects:	C Chemical Science > Chemistry
Divisions:	Department of > Chemistry
Depositing User:	LA manjunath user
Date Deposited:	28 Jul 2019 07:14
Last Modified:	01 Jun 2023 10:23
URI:	http://eprints.uni-mysore.ac.in/id/eprint/5959

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