Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING STRESS DEGRADATION METHOD FOR ESTIMATION OF LERCANIDIPINE USING HPTLC

Akansha A.*, Lalit R. and Poonam G.

ABSTRACT

As a calcium antagonist of the dihydropyridine group, lercanidipine prevents calcium from entering smooth and cardiac muscle across the membrane. Its direct relaxant impact on vascular smooth muscle lowers total peripheral resistance, which is the mechanism behind its antihypertensive effects. In this research work, forced degradation study of lercanidipine was carried out according to the ICH guideline Q1A(R2). The drug was subjected to acid (0.1N HCl), alkaline (0.1N NaOH), and neutral hydrolysis. Oxidative decomposition at room temperature, thermal study in hot air oven (50oC) and photo stability study by keeping drug in direct sunlight was also carried out. The product formed under different stress conditions were investigated by HPTLC. The result of analysis of HPTLC method was validated in terms of accuracy, ruggedness, linearity and range. The method was found to be sensitive, accurate, reliable, rapid and economic.

Keywords: Lercanidipine, Dihydropyridine, Antihypertensive, HPTLC, Oxidative.