2017•Asian Journal of Pharmaceutical AnalysisOpen access

Development of a RP-HPLC method for separation of ezetimibe in presence of atorvastatin caclium and simvastatin and its application for qunatitation of tablet dosage forms

Kavita Wagh, Sandeep Suresh Sonawane, Santosh Chhajad, Sanjay Jayprakash Kshirsagar

Abstract

A single, simple, accurate and precise RP-HPLC method has been developed for the estimation of ezetimibe in presence of atorvastatin calcium and simvastatin in bulk and marketed combined formulations. The chromatographic separation was achieved on C18 column (250 × 4.6 mm, 5 μ) using Acetonitrile: water 70: 30 v/v as a mobile phase at flow rate of 1.2 mL/min. The separation was achieved in isocratic mode and the detection was performed at 242 nm. Further the developed method was validated as per the ICH Q2 (R1) and applied for quantitation of atorvastatin calcium-ezetimibe and ezetimibe-simvastatin in tablet formulations.

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Key concepts: Ezetimibe, Simvastatin, Atorvastatin, Mathematics, Chromatography, Dosage form, Medicine, Biomedical engineering