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Sci. Pharm. 2011, 79(3), 601-614; doi:10.3797/scipharm.1105-16

Synthesis, Characterization and Quantification of Simvastatin Metabolites and Impurities

Department of Pharmaceutical Chemistry, Bharati Vidyapeeth College of Pharmacy, Near Chitranagari, Kolhapur-416013(M.S.), India
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Received: 25 May 2011 / Accepted: 25 July 2011 / Published: 25 July 2011
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Abstract

Simvastatin is used in treatment of hypercholesterolemia because it regulates cholesterol synthesis as a result of its β-hydroxy acid acting as an inhibitor of 3-hydroxy-methylglutaryl coenzyme A (HMG-CoA). The present communication deals with synthesis, characterization and development of accurate, precise and sensitive Reverse Phase High Performance Liquid Chromatography (RP-HPLC) method for simultaneous estimation of simvastatin and its synthetic impurities. The impurities methyl ether and β-hydroxy acid of simvastatin were synthesized in the laboratory and characterized by MS, NMR and FT-IR spectroscopy. The separation of simvastatin and its impurities was carried out on an isocratic JASCO RP-HPLC system using KYA TECH HIQ SIL C18 column (150 x 4.6 mm internal diameter, particle size 5 μm) operating at ambient temperature using acetonitrile:water (80:20 v/v) with 0.1% orthophosphoric acid as mobile phase. The method developed for HPLC analysis of three impurities along with simvastatin was validated using ICH Q2B (R1) guidelines and it complied with these guidelines. The results of analysis were found to be in the range of 98.14% to 101.89% for all analytes with acceptable accuracy and precision. The method can be used for detection and quantification of synthetic impurities in bulk or formulations of simvastatin.
Keywords: Simvastatin; β-Hydroxy acid; Methyl ether of simvastatin; RP-HPLC Simvastatin; β-Hydroxy acid; Methyl ether of simvastatin; RP-HPLC
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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MDPI and ACS Style

BHATIA, M.S.; JADHAV, S.D.; BHATIA, N.M.; CHOUDHARI, P.B.; INGALE, K.B. Synthesis, Characterization and Quantification of Simvastatin Metabolites and Impurities. Sci. Pharm. 2011, 79, 601-614.

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