Abstract

ANALYTICAL METHOD DEVELOPMENT & VALIDATION FOR SIMULTANEOUS ESTIMATION OF OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE IN PHARMACEUTICAL DOSAGE FORM BY RP-HPLC METHOD

Samatha. D*, Preetika Soanpet, Lakshmi Prasanna, Divya Bharathi, Rama Raju

ABSTRACT

A simple, fast, precise reverse phase isocratic high performance liquid chromatographic (HPLC) method has been developed for the simultaneous estimation of Olmesartan medoxomil (OM) and hydrochlorothiazide (HCTZ) in marketed formulations. Estimation of drugs in this combination was done with a C18 column [ODS-3 column, 250mm x 4.6mm 5μ] using mobile phase of composition phosphate buffer and acetonitrile ( pH 6.8, 65:35v/v). The flow rate was 1.0 ml/min and the separation was monitored at 224 nm. The retention time of HCTZ and OM were 4.365 min and 15.301 min respectively. The method was found to be linear over a range of 49-149μg/ml for OM and 31-93μg/ml for HCTZ. The method was validated according to the guidelines of International Conference on Harmonisation (ICH) and was successfully employed in the estimation of commercial formulations.

Keywords: Olmesartan medoxomil, Hydrochlorothiazide, Method validation,RP-HPLC, ICH guidelines.