DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMVASTATIN USING LOVASTATIN AS INTERNAL STANDARD
Abstract
Simvastatin is a potent competitive inhibitor of 3hydroxy-3-methylglutaryl coenzyme A reductase, which is a rate-limiting enzyme in cholesterol biosynthesis. It may also interfere with steroid hormone production due to the induction of hepatic LDL receptors, it increases breakdown of LDL cholesterol. We have established a sensitive and accurate High performance liquid chromatographic method for determination of Simvastatin as per the ICH guidelines using specificity, linearity, limit of detection, limit of quantification, Precision and accuracy. Chromatography was performed with an analytical Inspire C18 column (250 mm x 2.0 mm, 5 µm), Shimadzu HPLC model with LC 10AD HPLC Pump and SPD 10A HPLC UV-Detector, and using acetonitrile: 0.1% glacial acetic acid (80: 20 % v/v) as the mobile phase. The linearity of Simvastatin is 0.999 over a concentration range of 0.1 to 10 µg/ml. Interday and intraday variability was < 10%.
Keywords: Simvastatin, Lovastatin, HPLCDOI
https://doi.org/10.22270/jddt.v4i3.871Published
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