Determination of Nifedipine by Validated RP-HPLC Method in Bulk and Pharmaceutical Dosage Form

Abstract

The present paper deals with the development and validation of reverse phase HPLC method for the determination of Nifedipine on Nucleosil 100, 5 μm, C₈, 250 x 4.0 mm column. A mobile phase consisting of 40 ml 2-propanol: 60 ml phosphoric acid 0.85% was employed in this study. The flow rate was kept at 0.8 ml/min and the injection volume was 10 µl. The separation was performed at 40°C. Eluents were monitored by UV detector set at 237 nm. The developed method was statistically validated for the linearity, precision, robustness, specificity and solution stability. The specificity of the method was ascertained by force degradation studies by acid and alkali hydrolysis, oxidation, heat and photo degradation. The degraded products were well resolved from the analyte peak with significant differences in their retention time values.