Assay Method Development and Validation of Felodipine in Solid Dosage Form by Spectrofluorimetric and HPTLC Method and It's Force Degradation Study Using DOE Approach

Abstract

For the analytical determination of FELODIPINE two accurate and reproducible methods were used. These two methods are the High-Performance Thin Layer Chromatography and the Spectrofluorimetric method. The first method is HPTLC which is based on the separation of Drugs on HPTLC instrument using Aluminum Sheet precoated with silica gel 60 F254, using Chloroform: ethyl acetate: Ammonia (7:3:1) as a Mobile phase was confirmed by the use of DOE approach . The spot was measured at 363 nm with an Rf value of 0.57±2. The validation was further carried out where the linear regression data in the concentration range of 100-700ng/band gave a linear relation with r2 of 0.992. Further Felodipine was given stressed test conditions such as acid, neutral hydrolysis, alkali, oxidative and dry heat. The second method is the Spectrofluorimetric method where it measured Excitation wavelength 285 nm and emission wavelength at 580nm in methanol. Here the linearity was calculated for concentration range from 10-50μg/ml where the r2 is 0.991. The validation of both the method was done as per ICH guidelines in terms of Accuracy, Linearity, Precision, Robustness, Limit of Detection, and Limit of quantification.