Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC AND UV METHODS FOR SIMULTANEOUS ESTIMATION OF ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE IN BULK AND PHARMACEUTICAL DOSAGE FORM

Dr. Damerakonda Kumara Swamy*, Sai Krishna Guduru and Ch. Prashanthi

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Abstract

To develop simple, accurate, precise and rapid reverse phase high performance liquid chromatography method and Two UVSpectrophotometric methods have been developed for the simultaneous estimation of Enalapril maleate and Hydrochlorothiazide in bulk and pharmaceutical dosage form. In RP-HPLC analysis is carried out using Methanol: Acetonitrile (9:1, v/v) as the mobile phase at a flow rate of 0.5mL/min. this method includes Shimadzu LC-2010 instrument, Zodiac C18 (250 4.6mm, 5μm) column as stationary phase with detection wavelength of 238nm. Retention time of Enalapril maleate and Hydrochlorothiazide was found to be 2.340 & 2.992 respectively. The linearity of proposed method in the range of 1-5μg/mL (HPLC) & 2-10μg/mL (UV) for both Enalapril maleate and Hydrochlorothiazide respectively. The LOD of Enalapril and Hydrochlorothiazide was 0.091&0.072μg/mL respectively. The LOQ of Enalapril and Hydrochlorothiazide was 0.314&0.219μg/mL. The first UV method was determination using the Q-absorbance ratio method at 238nm & 262nm over the concentration range 2-10μg/mL respectively. The second UV method using determination of the Area under the curve method at 222-232 & 262-272nm over concentration range of 2-10μg/mL for Enalapril maleate and Hydrochlorothiazide respectively. The Regression equation of both drugs were 0.999.

Keywords: Enalapril maleate, Hydrochlorothiazide, RP-HPLC, UV-Methods, Stability studies.