Abstract

METHOD DEVELOPMENT AND VALIDATION OF FLUVASTATIN BY RP-HPLC

Mallepally Monika*, Ch. Sai Preethi, D. Aruna Rekha, Durgesh Pandey and G. Madhuri

ABSTRACT

A simple, economic, accurate, precise, robust and highly selective stability indicating reverse phase high performance liquid chromatography (RP-HPLC) method has been developed and validated using Fluvastatin. It is an anti lipidemic agent.Chromatographic separation was achieved using Shimadzu, LC 100 separation module, Agilent C18 column at temperature 30o centigrade. Flow rate selected was 1ml/min. Drug is detected at 202nm. Mobile phase employed was Acetonitrile: water (50:50), which resulted best sensitivity. Developed method was validated in terms of linearity range (25-150 μg/ml), and correlation coefficient was found to be 0.998. The method was validated for the linearity, accuracy, precision, robustness, system suitability as per ICH guidelines. The validation of proposed method was verified by recovery studies and can be applicable in routine pharmaceutical analysis.

Keywords: RP-HPLC, Acetonitrile, Fluvastatin, HPLC grade water.