DEVELOPMENT AND VALIDATION RP-HPLC METHOD FOR ANALYSIS OF FELODIPINE IN BULK AND PHARMACEUTICAL DOSAGE FORM

Abstract

The aim of present study was to develop and validate new simple, easy, selective, precise and accurate reverse phase high performance liquid chromatography for the estimation of Felodipine in bulk and pharmaceutical dosage form. The separation was carried on HPLC system consisting C-18 column (150 x 4.6 mm, 5 $\mu $m) at room temperature coupled with a guard column of silica with flow rate 1 ml/min. The mobile phase used was Acetonitrile: Water in the ratio 70:30. The drug was detected using UV-Vis detector at the wavelength of 238 nm and the run time was 10 minutes. The retention time was 8.29 minutes. The percentage RSD for precision and accuracy of the method was found to be less than 2 %. The method was validated as per ICH guidelines. The proposed method was found to be accurate, repeatable and consistent. It was effectively applied for the analysis of the drug in marketed formulation and could be used for the regular analysis of formulation containing the Felodipine.