Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR DETERMINATION OF LACIDIPINE AND ITS RELATED IMPURITIES IN TABLETS

P.Gayathri*, Prof K.N.Jayaveera, E. Sasi Kiran Goud

ABSTRACT

A simple, sensitive and accurate gradient reverse phase high performance liquid chromatography method was developed for determination of lacidipine and its related impurities in tablets. The effective separation was achieved on Thermo Hypersil BDS C18 150 x 4.6 mm column with particle size 5μm. The mixture of buffer and methanol in the ratio 90: 10 v/v used as a mobile phase-A and the mixture of buffer and methanol in the ratio 10:90v/v used as a mobile phase-B. The buffer was prepared as 4.0 g of ammonium acetate in 2000 ml of purified water and adjusts the pH 6.5 with glacial acetic acid. The flow rate of the mobile phase was 0.8 mL/min and the total elution time was 60 minutes. The UV detection wavelength was carried at 242 nm and experiments were conducted at 30°C. The developed method was validated in terms of system suitability, selectivity, linearity, precision, accuracy, limits of detection and quantification for the impurities following the ICH guidelines.

Keywords: Lacidipine tablets, Method development, Hypersil BDS C18 and RP-HPLC.