ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF FELODIPINE IN BULK AND TABLET DOSAGE FORM BY USING RP-HPLC TECHNIQUES

This paper describes the analytical method suitable for validation of Felodipine by reversed Phase High Performance Liquid Chromatography (RP-HPLC) method. The method utilized RP-HPLC (Water 2695 with PDA detector) model and a column ODS C18 (4.6 x 150mm, 5m). The mobile phases were comprised with Acetonitrile and Water (80:20 V/V) at a flow rate of 1.0 ml/min. UV detection at 305 nm MTS were eluted with retention times of 3.155min. The method was continued and validated accordance with ICH guidelines. Validation revealed the method is rapid, specific, accurate, precise, reliable, and reproducible. Calibration curve plots were linear over the concentration ranges 15-75 μg/mL (R2 = 0.9998). Limit of detection (LOD) was 0.19µg/ml and limit of quantification (LOQ) was 0.6µg/mL. The method showed good recoveries (98.9 - 100.4%). Statistical analysis was proves the method is suitable for the analysis of Felodipine as a bulk, in tablet dosage form without any interference from the excipients. It was also proved study for degradation kinetics. It may be extended for its estimation in plasma and other biological fluids. Keywords: Felodipine, RP-HPLC, Method Development and Validation