Abstract

DEVELOPMENT AND VALIDATION OF HPTLC METHOD FOR DETERMINATION OF GLICLAZIDE IN API AND PHARMACEUTICAL DOSAGE FORM

Amit Aher and Hemant Kumar Jain*

ABSTRACT

The aim of present work was to develop a simple and sensitive, HPTLC for the quantitative estimation of Gliclazide in its single component tablet formulations (40 mg). Gliclazide was chromatographed on silica Gel 60 F254 TLC plate using Toluene:Chloroform: methanol (4:4:2 v/v) as mobile phase. Gliclazide in methanol was scanned by Camag TLC scanner 4 with UV visible detector over wavelength range 200 to 400 nm. Gliclazide showed Rf value 0.35 and scanned at 230 nm using Camag TLC Scanner. The method was validated in terms of linearity (4-14 ng/ml), precision (intra-day variation 2.164, inter-day variation 2.614), accuracy (86.34to 92.20%) and specificity. The limit of detection and limit of quantification for Gliclazide were found to be 0.5 ng/spot and 1.53 ng/spot, respectively. It can be concluded from the results that the proposed method was accurate, precise and consistent the determination of Gliclazide in tablet dosage form. This method was validated as per ICH guideline Q2 (R1). Results suggest that this method can be used for routine estimation of Gliclazide in bulk and pharmaceutical dosage forms.

Keywords: Gliclazide, Toluene, Methanol, Chloroform, HPTLC.