Objective: Method validation is an important aspect for the determination of pharmaceutical products. A well validated method play an important role in the control of quality of the products. So this purpose the proposed study have been done regarding develop a validated method for losartan potassium.
Methods: A reversed phase high performance liquid chromatographic method used on isocratic mode.
Results: The chromatographic separation of losartan potassium was obtained using a C
18 column by isocratic elusion at the 25
0C column temperature. The green solvent (methanol and water, 30:70 v/v) was used as a mobile phase. The analysis was performed at the flow rate 1.0 ml/min. A well defined peak was detected at 273 nm. The retention time of acive engredients losartan potassium was obtained in 7 min. The limit of detection and limit of quantification was calculated 0.03 and 0.09 µg/ml, respectively. A Good results was obtained with respect to linearity R
2=0.998. The mean recoveries in inter-day and intra-day were calculated 98.85 % and 99.4 % with CV value 1.38 and 2.24 respectively.
Conclusion: The method was validated according to ICH guidelines. This method is very efficient for the analysis of losartan potassium at 25
0C.