Abstract

STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT FOR DETERMINATION OF SIMVASTATIN IN DOSAGE FORMS

Praveen Kumar*, Guno Sindhu Chakraborthy

ABSTRACT

A reliable and sensitive isocratic stability indicating RP-HPLC method has been developed and validated for assay of Simvastatin in tablets and for determination of content uniformity. An isocratic separation of Simvastatin was achieved on Zorbax SB C18 (250mm x 4.6mm), 5 μm particle size columns with a flow rate of 1 ml/min and using a UV detector to monitor the eluate at 238 nm. The mobile phase consisted of Methanol: water (70:30 v/v).The drug was subjected to oxidation, hydrolysis, photolysis and thermal degradation. All degradation products in an overall analytical run time of approximately 8 minute with the parent compound Simvastatin eluting at approximately 4.75 minute. Response was a linear function of drug concentration in the range of 2-20 μg/ml with correlation coefficient (r 2 = 0.9992). Accuracy (recovery) was 100.79.  1.51%. Degradation products resulting from the stress studies did not interfere with the detection of Simvastatin and the assay is thus stability-indicating.

Keywords: Content uniformity, method validation, Simvastatin, stability- indicating.