Abstract
Author(s): Ramchandra Krishna Pawar*, Ram Lokhande, Ravi Yadav, Bhanupratap Bind, Shirish Velankar
A Revered Phase HPLC method was developed and validated for determination of Assay for Diltiazem HCl Active Pharmaceutical ingredient (API). The method was validated as per ICH Q2 (R1) and FDA guidelines and found to be simple, specific, linear, precise and robust which can be used for routine analysis purpose. The separation was achieved by using HPLC column Ascentis Express C18 column having dimension 7.5cm x 4.6mm and particle size 2.7μm. The mobile phase consists of mixture of 0.1% Triethylamine pH-3.0 (Previously adjusted with orthophosphoric acid) and Acetonitrile in the ratio of 65:35 v/v. The column temperature and mobile phase were constantly maintained at 50ºC and 1.0 ml/min respectively. The detection was performed at wavelength 236 nm using PDA detector. The retention time of Diltiazem peak was found to be about 1.5 minutes. The method was specific as no interference was observed at retention time of Diltiazem peak. The linear regression analysis data for the calibration curve shows a linear relationship over the concentration range of 50-150μg/mL for Diltiazem HCl and the correlation coefficient value obtained was 0.9999. The experimental data shows that the method was Specific, Linear, Precise and Robust for the Assay determination of Diltiazem Active Pharmaceutical ingredient.
