Sensitive High Performance Thin Layer Chromatographic Determination of Lercanidipine Hydrochloride in Pharmaceuticals and in Blood Plasma

Abstract

A HPTLC method was developed and validated for determination of Lercanidipine
hydrochloride in tablet formulation and in biological sample. The chromatography was
performed on pre-coated silica gel 60 F254 plates using methanol-toluene 2.5:7.5 (v/v) as
mobile phase. The optimized chromatographic conditions gave good peak shape with
acceptable Rf value of 0.70 for Lercanidipine. Method was validated according to the ICH
guidelines. The calibration plots were linear between 100-600 ng/ band and between
50-500 ng/ band in pure and in biological sample, respectively. Accuracy of the
proposed method was evaluated by recovery studies (% recovery= 100.22 % and 99.99
% from tablet sample and biological sample, respectively). The method was also
validated for precision, ruggedness, LOD & LOQ and robustness as per ICH guidelines. In
stability testing, Lercanidipine was found susceptible to acid hydrolysis, alkali
hydrolysis and oxidation (3 % H2O2). The method was able to selectively quantitate
Lercanidipine hydrochloride in presence of degradation products and components likely
to be present in biological matrix.