Abstract

ANALYTICAL METHOD DEVELOPMENT AND FORCE DEGRADATION STUDY TO DETERMINE INHERENT STABILITY BY RP-HPLC METHOD FOR THE RELATED SUBSTANCES OF LERCANIDIPINE HYDROCHLORIDE IN LERCANIDIPINE HYDROCHLORIDE TABLETS 10MG

Anjani L. Singh* and Amrish Chandra

Abstract

A simple, accurate, selective, specific and stability indicating method was developed by RP-HPLC method for estimation of related substance Lercanidipine Hydrochloride in Lercanidipine Hydrochloride Tablet. A gradient RP-HPLC method was developed and force degradation study performed on C-8 Column, Water symmetry C8, 250 X 4.6mm, 5  or equivalent, using Sodium Perchlorate Monohydrate with pH 4.0 with Acetonitrile in the ration of 50:50 v/v as mobile phase. The flow rate was adjusted to 1.5 ml/min, column oven temperature 30°C and the detection wavelength was 220 nm with 70 minutes run time (for sample solution, system suitability solution, diluent, placebo Solution), 30 minutes (For diluted standard). The retention time for Lercanidipine Hydrochloride was found to be 20 minutes. Proposed method was validated for specificity and force degradation study. This validation study is intended to show that the method is stability indicating and is suitable to determine inherent stability of drug for Lercanidipine Hydrochloride in Lercanidipine Hydrochloride Tablets of 10 mg and 20mg dosage strengths.

Keywords: Lercanidipine Hydrochloride, Impurities, RP- HPLC, Stability indicating, Force Degradation.