Abstract
DEVELOPMENT AND VALIDATION OF HPTLC METHOD FOR DETERMINATION OF GLICLAZIDE IN BULK AND PHARMACEUTICAL DOSAGE FORM
Aarti Gaikwad*, Dr. Kisan Jadhav, Dr. Vilasrao Kadam
ABSTRACT
The determination of the active agent both qualitatively and quantitatively is important to ensure a quality of the product. The present work is aimed to develop and validate a simple, economic and sensitive High-Pressure Thin Layer Chromatography method to analyse Gliclazide in bulk as well as in its single component tablet formulation. GLZ was chromatographed on Silica Gel 60 F254 precoated TLC plates and Toluene: Acetonitrile: Methanol (7:2:1 v/v) was selected as a mobile phase. GLZ dissolved in methanol was scanned over the range of 200 to 400 nm by Camag TLC scanner 4. GLZ showed Rf value 0.55 at 231 nm. The developed method was validated in terms of linearity, range, precision, accuracy, robustness as per the International Conference on Harmonization guidelines Q2 (R1). It showed a significant calibration coefficient 0.993 with a linearity of concentration (40- 280ng/spot).The limit of detection (LOD) and the limit of quantification (LOQ) of the method was found to be 1.64 and 4.97 ng/spot respectively.
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