A LIQUID CHROMATOGRAPHIC MEHTOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF AMLODIPINE BESYLATE AND LOSARTAN IN PURE AND MARKETED FORMULATIONS

Bathula Santhi Priya*, L. Ramachandra Reddy and D. Dhachinamoorthi

ABSTRACT

A novel, simple, accurate, stability indicating reverse phase liquid chromatographic method was established and validated for the simultaneous quantification of amlodipine besylate and losartan in pure and marketed formulations. Quantification of the selected drugs was done with a C18 column Agilent column. 250mm × 4.6 mmusing mobile phase of composition Acetonitrile and phosphate buffer (60:40 v/v, pH 3). The flow rate was 0.8 ml/min and the effluents were monitored at 226 nm. The retention time of Amlodipine besylate and Losartan were 2.9 min and 4.2 min respectively. The method was found to be linear over a range of 10-50 g/ml for Amlodipine besylateand 2-10 g/ml for Losartan. The established method proved as reproducible one with a %RSD value of less than 2 and having the robustness and accuracy within the specified limits. Assay of marketed formulation was determined and find with 99.08% and 99.87% for Amlodipine besylate and Losartan respectively. The stressed samples were analyzed and this proposed method was found to be specific and stability indicating as no interfering peaks of degradation compounds and excipients were noticed. The method was validated according to the guidelines of International Conference on Harmonization (ICH) and was successfully employed in the estimation of commercial formulations. This liquid chromatographic method can be applied for the qualitative and quantitative determination of selected drugs by the modern chemist.

Keywords: Amlodipine, Losartan, RP-HPLC, Stability and Method validation.