ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR ESTIMATION OF LERCANIDIPINE HYDROCHLORIDE AND ENALAPRIL MALEATE IN COMBINATION

Stability indicating RP-HPLC method for simultaneous estimation of Lercanidipine Hydrochloride and Enalapril Maleate in their Combined Dosage Form has been developed. A reverse phase high performance liquid chromatographic method was developed for the simultaneous estimation of Lercanidipine HCl and Enalapril Maleate in their combined dosage form. The separation was achieved by column C18 (250mm x 4.6 mm) Hypersil BDS and Buffer (pH 5.0): Methanol (30:70 % v/v) as mobile phase, at a flow rate of 1 ml/min. Detection was carried out at 233 nm. Retention time of Lercanidipine HCl and Enalapril Maleate were found to be 4.057 min and 6.470 min respectively. The method has been validated for linearity, accuracy and precision. Linearity observed for Lercanidipine HCl 10-30 μg/ml and for Enalapril Maleate 20-60 μg/ml. Developed method was found to be accurate, precise and rapid for simultaneous estimation of Lercanidipine HCl and Enalapril Maleate In Their Combined Dosage Form Keywords: Lercanidipine HCl, Enalapril Maleate, Stability indicating RP-HPLC Method, Validation Method