Development and validation of RP-HPLC method for simultaneous estimation of Hydrochlorthiazide and Olmesartan medoxomil in bulk and pharmaceutical dosage form

Abstract

A simple and sensitive gradient RP-HPLC method was developed for the simultaneous estimation of Hydrochlorthiazide and Olmesartan medoxomil present in bulk and their pharmaceutical dosage form using Inertsil ODS C18 (150 × 4.6 mm i.d, packed with 5 μ particle size) column at 30°C in an gradient mode with mobile phase comprising 0.2% acetate buffer: Acetonitrile. The flow rate was 1.2 ml/min and effluent was monitored at 252 nm. The retention time were found to be 5.080 min for Hydrochlorthiazide and 10.493 min for Olmesartan, respectively. The assay exhibited a linear concentration range of 25–150 μg/ml for Hydrochlorthiazide and 20–120 μg/ml for Olmesartan with a correlation coefficient of 0.9998 for Hydrochlorthiazide and 0.9994 for Olmesartan, respectively. The overall mean % recovery was found to be 100.2 for Hydrochlorthiazide and 101.4 for Olmesartan, respectively. The proposed method was statistically developed and validated as per ICH guidelines and can be applied for routine quality control analysis of Hydrochlorthiazide and Olmesartan medoxomil in pharmaceutical dosage forms.