Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING ASSAY METHOD OF LACIDIPINE BULK DRUG AND IT’S MARKETED FORMULATION BY RP-HPLC.

Sonawane Yogesh *, Chopade Vitthal, Chaudhari Pravin

Abstract

A simple, sensitive, precise and stability indicating RP-HPLC method of analysis of lacidipine in bulk as well as formulation was developed and validated. Separation was carried out on Inertsil C18 column (250mm x 4.6mm x 4.6mm, 5 um particle size) using mobile phase Acetonitrile : Methanol (55:45 v/v) at PDA detector. The drug was subjected to stress degradation conditions like acid, alkaline, oxidative, photo and thermal degradation. The method was validated for specificity, linearity, precision, accuracy, robustness and solution stability. Method was found to be linear with correlation coefficient 0.998 and also found to be robust as %RSD values are less than 2%. Stress degradation study shows that lacidipine undergoes degradation in acid, base and oxidation (15.20%, 5.96%, 11.24% respectively). Degradation products which are formed during studies did not interfere in detection of lacidipine and thus assay can be considered stability indicating.

Keywords: Lacidipine, Stability indicating assay, RP-HPLC, Stress degradation condition.