Development and Validation of Stability Indicating UPLC Method for Simultaneous Determination of Olmesartan Medoxomil and Chlorthalidone in Bulk and Pharmaceutical Dosage Form

Abstract

Aim: The establishment and validation of simultaneous determination of Olmesartan medoxomil and chlorthalidone by UPLC according to ICH guidelines ensure that the analytical method meets regulatory standards and can be used effectively for quantitative analysis of these compounds.

Objectives: To develop a new UPLC method for simultaneous estimation of Chlorthalidone and Olmesartan to develop a validated method according to ICH guidelines. To apply a validated technique for the estimation of Chlorthalidone and Olmesartan in pharmaceutical formulation.

Methods: The analysis employs an ACQUITY UPLC HSS C18 column with dimensions of 2.1 mm x 50 mm and a particle size of 1.8 µm. The mobile phase consists of a 60:40 mixture of orthophosphoric acid (OPA) and acetonitrile (ACN). This mobile phase is passed through the column at a flow rate of 0.4 mL/min, with the column temperature held constant at 30.0°C. The detection of Olmesartan and Chlorthalidone is optimized at a wavelength of 235 nm.

Results: : Retention time of Olmesartan and Chlorthalidone was found to be 1.134 min and 1.535 min. %RSD of the Olmesartan and Chlorthalidone was and found to be 0.1 and 0.6 respectively. %Recovery was Obtained as 99.95 % and 99.38% for Olmesartan and Chlorthalidone. LOD, LOQ values were obtained from regression equations of Olmesartan and Chlorthalidone were 0.08ppm, 0.25ppm and 0.09ppm, 0.26ppm respectively. Regression equation of Olmesartan is y = 29829x + 9806.4, and Chlorthalidone is y = 32492x + 2718.1.

Conclusions: The newly developed method shows to be simple and economical, with shorter run durations and lower retention times. This makes it appropriate for regular quality control testing in industrial settings.