Stability Study of the Calcium Channel Blocker Lercanidipine and its Determination by Reversed Phase Chromatography in Pharmaceutical Formulation and Plasma

Abstract

A sensitive, selective, and rapid stability indicating RP-HPLC method was developed and validated for determination of Lercanidipine (LERC) in presence of its acidic, basic, and oxidative degradation products in bulk powder, pharmaceutical formulation, and human plasma, using benazepril (BENZ) as an internal standard (IS). The method uses Inertsil C18 column (250 x 4.6mm, 5µ) and acetonitrile-potassium hydrogen phosphate buffer pH = 3.5 (55/45 v/v) as a mobile phase. The flow rate was 1.0 mL/min and the detection wavelength was 235 nm. A detailed validation of the method was performed following the ICH guidelines and the standard curve was found to be linear in the range of 1-30 µg/mL for Lercanidipine. Statistical comparison was done between the proposed method and the reported one where no significant difference was found between the two methods. Also the method was applied to spiked human plasma.