Method development and validation for simultaneous estimation of telmisartan and amlodipine by RP-HPLC

Abstract

A novel, precise, accurate, rapid and effective isocratic RP-HPLC method was developed, optimized and validated for the estimation of Telimsartan (TEL) and Amlodipine (AML) in pharmaceutical dosage forms (tablet). The drugs were estimated using Symmetry C18 (250 x 4.6 mm, 5 µm) column. A mobile phase composed of phosphate buffer of pH 6 and acetonitrile in the ratio of 40:60, v/v), at a flow rate of 0.8 ml/min was used for the separation. Detection was carried out at 243 nm. The linearity range obtained was 16-48 µg/ml for TEL and 2-6 µg/ml for AML with retention times (_Rt) of 3.209 min and 5.351 min for TEL and AML respectively. The correlation coefficient values were found to be 0.999. Precession studies showed % RSD values less than 2 % for both the drugs in all the selected concentrations. The percentage recoveries of TEL and AML were in the range of 98.01-101.62% and 99.30-101.40% respectively. The assay results of TEL and AML were 99.60% and 99.75% respectively. The method was validated as per the International Conference on Harmonization (ICH) guidelines. The developed validated method was successfully used for the quantitative analysis of commercially available dosage form.