ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RPHPLC METHOD FOR ESTIMATION OF AMLODIPINE BESYLATE AND CELECOXIB IN SYNTHETIC MIXTURE.

A simple, rapid, economical, precise and accurate HPLC method for simultaneous estimation of Celecoxib and Amlodipine Besylate in their combined dosage form has been developed. A Stability indicating reverse phase high performance liquid chromatographic method was developed for the simultaneous estimation of Celecoxib and Amlodipine Besylate in their combined dosage form. The separation was achieved by LC- 20 AT C18 (250mm x 4.6 mm x 2.6 ?m) column and Buffer (Potassium Phosphate, pH 4.5): Methanol (85:15) at a flow rate of 1 ml/min. Detection was carried out at 240 nm. Retention time 4.080 min and 5.343 for Celecoxiband AmlodipineBesylaterespectively.Themethodhasbeenvalidatedforlinearity, accuracy and precision. Linearity observed for Celecoxib 20-60 μg/ml and for Amlodipine Besylate 1-3 μg/ml. Developed method was found to be accurate, precise and rapid for simultaneousestimationofCelecoxibandAmlodipineBesylateintheircombineddosageform. The proposed method was successfully applied for the simultaneous estimation of both the drugs in commercial Combineddosageform. The drug was subjected to stress condition of hydrolysis, oxidation, photolysis and Thermal degradation, Considerable Degradation was found in Thermal degradation. The proposed method was successfully applied for the simultaneous estimation of both the drugs in commercial Combined dosage form.