ANALYTICAL ASSAY METHOD VALIDATION AND STRESS DEGRADATION BEHAVIOR OF S (-) AMLODIPINE BESYLATE AND S (-) ATENOLOL FROM BULK AND COMBINED DOSAGE FORM

The analytical method validation process was established for the combined dosage form of S (-) Amlodipine Besilate and S (-) Atenolol tablets. The forced degradation study was carried out for drug substances and for drug product as per ICH guidelines. The peaks were homogeneous as peak threshold value found greater than peak angle. The developed protocol applied to the analytical method validation for assay of S (-) Amlodipine Besilate and S (-) Atenolol from combined dosage form by high performance liquid chromatography. The column having specifications as Inertsil C8-3 (250mm x 4.6 mm internal diameter and 5 ? particle size) and mobile phase comprising of buffer: acetonitrile (600:400) was used. The method applies for strength formulated [S (-) Amlodipine Besilate 5mg and S (-) Atenolol 50mg/tablet]. Linearity studies showed correlation coefficient as 0.9998 and 0.9964 for S (-) Amlodipine Besilate and S(-) Atenolol, respectively No interference and adsorption of active ingredients was observed for filter papers and these were found to be compatible with formulation excipients. Thus developed analytical method was found to be specific, linear, precise, accurate, robust and rugged