DEVELOPMENT AND VALIDATION OF STABILITY-INDICATING HPTLC METHOD FOR ESTIMATION OF CELECOXIB AND AMLODIPINE BESYLATE FROM SYNTHETIC MIXTURE

The current research paper describes a highly specific, reproducible, and efficient stability-indicating HPTLC method for estimation of Celecoxib and Amlodipine Besylate from its synthetic mixture. Chromatographic separation and quantification carried out on Merck HPTLC aluminum sheets of silica gel 60 F254 using Chloroform: Acetone: Toluene: Methanol in the ratio of 5:3:2:0.5 v/v/v/v as solvent system. This system was found to give compact and dense spots for CXB and AML with the R_f value of 0.80, 0.23 respectively. Densitometric analysis of CXB and AML was done at 238 nm and 366 nm. Regression analysis for the calibration plots was indicative of good linearity between response and concentration over the range of 0.2-1.2 µg/spot for AML and 4-24 µg/spot for CXB. Forced degradation studies were performed under different conditions. Both drugs were degraded in acidic, basic, oxidative, thermal, and photolytic conditions. In the present research, a stability-indicating HPTLC method has been developed for Celecoxib and Amlodipine Besylate. The developed method was validated as per ICHQ2R1 guidelines and was successfully applied for quantitative analysis of synthetic mixture of Celecoxib and Amlodipine Besylate.