Development and Validation of Liquid Chromatography (RP-HPLC)Methodology for Estimation of Efonidipine HCl Ethanolate (EFD)

Abstract

A Reversed Phase High Performance Liquid Chromatographic (RP-HPLC) method using symmetry C18, 5.0 mm column was developed for the determination of Efonidipine Hydrochloride Ethanolate (EFD). The mobile phase acetonitrile and water ratio was selected 85: 15 via flow rate were 0.8 mL/min and elution was monitored at 254 nm. Response was a linear function of concentration over the range 20-140 μg/ml (R2=0.9994) and the limits of detection was 681.83 ng/ml. The limit of quantification was 2.06 μg/ml. The coefficient of variation for intra-assay and inter-assay precision was less than or equal to 1.5% and the accuracy was 104.0-105.0% and method was validated accordance with International Conference on Harmonization (ICH) guidelines to check content uniformity. In this lieu, a simple and rapid with good accuracy precision validated method is developed which is applicable in quality-estimation, in-future.