Abstract

DEVELOPMENT AND VALIDATION OF HPTLC METHOD FOR DETERMINATION OF DARUNAVIR ETHANOLATE IN BULK AND TABLETS

Hemant Kumar Jain*, Umakant Jadhav and K. N. Gujar

ABSTRACT

The aim of present work was to develop a rapid, simple and sensitive, HPTLC method for the quantitative estimation of Darunavir Ethanolate in bulk and tablets. Darunavir Ethanolate was chromatographed on silica Gel 60 F254 TLC plate using Toluene: Chloroform: Methanol (4:4:1 v/v) as mobile phase. Darunavir Ethanolate in methanol was scanned by Camag TLC scanner 4 with UV visible detector over wavelength range 200 to 400 nm. Darunavir Ethanolate showed Rf value 0.46 and scanned at 267 nm using Camag TLC Scanner. The method was linear over the concentration range (300-900 ng/spot), Precision (intra-day variation 2.759, inter-day variation 2.665), accuracy (83.3 to 87.8 %) and specificity. The LOD and LOQ for Darunavir Ethanolate were found to be 100 ng/spot and 300 ng/spot, respectively. The proposed method was accurate, precise and consistent the determination of Darunavir Ethanolate in tablet dosage form. This method was validated as per ICH guideline Q2 (R1). Results suggest that this method can be used for routine analysis of this drug in pharmaceutical industry.

Keywords: Darunavir Ethanolate, Validation, HPTLC.