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Abstract

VALIDATED METHOD DEVELOPMENT FOR SIMULTANEOUS ESTIMATION OF LOSARTAN POTASIUM AND CHLORTHALIDONE IN TABLET DOSAGE FORM BY RP-HPLC METHOD

Nitin S. Jadhav, K.G. Lalitha*

Abstract

A new, simple, rapid RP-HPLC method was developed and validated for the simultaneous estimation of Losartan potassium and Chlorthalidone in tablet dosage form. The chromatographic separation was achieved on a Agilent XDB C18( 150 x 4.6 mm, 5m) particle size column was used with PDA detector by using mobile phase containing mixture of 0.02M Potassium dihydrogen orthophosphate (KH2PO4) buffer : acetonitrile (70:30 % v/v pH 3.5) was used. The flow rate was 1 ml / min and detection was carried at 254 nm. The retention time for Chlorthalidone and Losartan was found to be 2.718 and 4.848 min. respectively. The method was linear over the concentration range of 12.5 - 75μg/ml for Losartan potassium and 1.55 – 9.35 μg/ml for Chlorthalidone respectively. Limit of detection (LOD) for Losartan potassium and Chlorthalidone was 0.121 μg/ml and 0.0168μg/ml. and Limit of quantitation(LOQ) for Losartan potassium and Chlorthalidone was 0.369μg/ml and 0.0510μg/ml respectively. The proposed method in this study was found to be simple, rapid, precise, accurate, sensitive and applicable for the simultaneous determination of Losartan potassium and Chlorthalidone in combined dosage forms.

Keywords: Losartan potassium, Chlorthalidone, RP-HPLC and ICH guidelines.


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