Development and Validation of Stability Indicating Method for Determination of Few Drugs in Bulk and Pharmaceutical by HPLC HPTLC

Abstract

A simple and sensitive, HPTLC method has been developed for the quantitative estimation of Amlodipine, Felodipine, Nisoldipine, Nifedipine and Clindipine in its single component tablet formulation. newlineThe separation was carried out on Merck aluminium plates precoated with silica Gel 60 F254 using Chloroform: Methanol (8.5:1.5 v/v) as mobile phase. Amlodipine showed Rf value of 0.53±0.027 and was scanned at 237 nm using Camag TLC Scanner3. The linear regression data for the calibration plot showed a good relationship with r=0.9947. Felodipine -mixture of n-hexane: Ethyl acetate (6: 4 v/v) could resolve spot with better peak shape. The drug was satisfactorily resolved with Rf value 0.53±0.027. Nisoldipine - mixture of Chloroform: Glacial acetic acid: Methanol (8.5: 1:0.5 v/v) could resolve spot with better peak shape. The drug was satisfactorily resolved with Rf value 0.29 ± 0.008. Nifedipine- mixture of Chloroform: Methanol: Ethyl acetate (6:2:2 v/v) could resolve spot with better peak shape. The drug was satisfactorily resolved with Rf value 0.59±0.027. Cilnidipine- mixture of Toluene: Chloroform: Ethyl acetate (6:2:2 v/v/v) could resolve spot with better peak shape. The drug was satisfactorily resolved with Rf value 0.43 ± 0.52. newlineThe further study extended for characterization of photo degradation of four dipine. By doing photo degradation analysis by LCMS study and try to find out their degradation pattern. newline