RP-HPLC method development and validation for simultaneous estimation of Losartan Potassium, Amlodipine Besilate and Hydrochlorthiazide in tablet dosage form
By S. Jayaseelan, M. Rajasekar, S. Ganesh, V. Sekar, P. Perumal
A high-performance liquid chromatographic method has been developed for the simultaneous analysis of Losartan potassium, Amlodipine besilate and Hydrochlorthiazide in combined solid dosage form. The mobile phase consisting of phosphate buffer (pH 7.0), methanol and acetonitrile in ratio of 60:20:20% v/v was delivered at the flow rate of 1.0 mL/min and UV detection was carried out at 238nm. The separation was achieved using C18 reverse-phase column (250 X 4.6 mm I.D., particle size 5μm). The method was linear over the concentration range of 200.24-300.36 μg/mL for Losartan potassium and 27.84-41.76 μg/mL for Amlodipine besilate and 50.00-75.00 μg/mL for Hydrichlorthiazide.The analytical recovery obtained was 100.15%. The validation of method carried out as per ICH guidelines. The described HPLC method was successfully employed for the analysis of pharmaceutical formulations containing combined dosage form and can be employed for bioequivalence study in future for the same formulations.
Keywords : RP-HPLC, Losartan potassium, Amlodipine besilate, Hydrochlorthiazide, Validation.