Abstract

DEVELOPMENT AND VALIDATION OF NEW ANALYTICAL METHODS FOR THE SIMULTANIOUS ESTIMATION OF RAMIPRIL AND HYDROCHLOROTHIAZIDE IN BULK DRUG AND PHARMACEUTICAL FORMULATIONS BY RP-HPLC

Pokala Pravalika, *Damerakonda Kumara Swamy, Sai Krishna Guduru, Thota Sreekanth

Abstract

A HPLC method for simultaneous estimation of Ramipril and Hydrochlorothiazide in Drug and Pharmaceutical formulation was developed and validated. The developed method involves Merck Hitachi L-7100 double reciprocating pump, UV detector L-7400 (190-666nm), 150×4.6mm column with mobile phase composition orthophosphate buffer: Acetonitrile (60: 40 v/v) with neutral pH, at a flow rate of 0.8 ml/min and UV detection at 226 and 253 nm for first five minutes for Hydrochlorothiazide and 270nm for Ramipril. The method was validated as per ICH guidelines; Linearity was observed over concentration range of 1 to 5 μg/ ml for Ramipril and 2.5 to 12.5 μg/ ml Hydrochlorothiazide. The Accuracy of the proposed method was determined by recovery studies and found to be 97.95-102.3% and 97.98-102.66% for Ramipril and Hydrochlorothiazide respectively. The proposed method was extended for estimation of Ramipril and Hydrochlorothiazide in marketed pharmaceutical formulation (AltaceHCT) and it was found to be well within the acceptance limit. The developed and validated HPLC method for simultaneous estimation of Ramipril and Hydrochlorothiazide was found to be linear, accurate, precise, robust and rugged. Hence it can be used for routine analysis of Ramipril and Hydrochlorothiazide in tablet.

Keywords: HPLC, Ramipril, Hydrochlorothiazide, Merck Hitachi.