Abstract
DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF AZILSARTAN AND CHLORTALIDONE IN BULK AND ITS PHARMACEUTICAL FORMULATIONS

N. Prasad Babu* and Dr. D. Ramachandran

ABSTRACT

A new simple, accurate, rapid and precise isocratic RP-HPLC was developed and validated for the determination of Azilsartan and Chlortalidone in Pharmaceutical tablet dosage form. The Method employs waters LC system on Hypersil ODS column (4.6 x 250 mm, 5 μm) and flow rate of 1.0ml/min with an injection volume 10μl. pH 4.2 phosphate Buffer, and acetonitrile was used as mobile phase in the composition of 55:45 v/v. The detection was carried out at 220nm. Linearity ranges for Azilsartan and Chlortalidone were 40-240 μg/ml, 25-150μg/ml respectively for HPLC. Retention time of Azilsartan and Chlortalidone were found to be 2.6 and 4.2 minutes respectively. Percent Recovery study values of Azilsartan and Chlortalidone were found 98.7-100.1% and 98.9-100.3% respectively. This newly developed method was successfully utilized for the Quantitative estimation of Azilsartan and Chlortalidone in tablet dosage form. This method was validated for selectivity, accuracy, precision, linearity and Robustness as per ICH guidelines.

Keywords: Liquid Chromatography, Azilsartan, Chlortalidone, Simultaneous estimation, Validation.


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