Analytical method validation, S (-)

The analytical method validation process was established for the fixed dosage combination of S (-) Amlodipine (Levoamlodipine) Besilate and Losartan potassium 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 the analytical assay method of S (-) Amlodipine Besilate and Losartan potassium for fixed dosage combination by HPLC. The HPLC column having specifications as Inertsil ODS-3 (25cm x 4.6 mm internal diameter, 5µ particle size) and mobile phase comprising of buffer: acetonitrile (75:25) was used. The method applies for strength formulated [S (-) Amlodipine Besilate 5mg and Losartan potassium 50mg/tablet]. Linearity studies showed correlation coefficient as 0.9998 for both the drugs. The % relativ