DEVELOPMENT AND VALIDATION OF HPTLC METHOD FOR ESTIMATION OF GLIMEPIRIDE IN ACTIVE PHARMACEUTICAL INGREDIENT AND PHARMACEUTICAL FORMULATION

The aim of the existing work was to develop a economical, simple, precise and accurate High performance thin layer chromatography (HPTLC) method for the estimation of Glimepiride in the single dosage tablet formulations and Active pharmaceutical ingredient. Chromatographic separation of Glimepiride was achieved on TLC aluminum plates precoated with silica gel 60 F254 using mobile phase as Acetone: Toluene (8:1 v/v). The detection of Glimepiride was completed at absorbance mode at 231 nm using Camag TLC Scanner. Glimepiride demonstrated Rf value at 0.73. The Method was validated in term of linearity (500-1750 ng/spot), Precision (% RSD for Repeatability 1.43%, % RSD for intraday variation 1.66% and inter-day variation 0.60%), Accuracy in term of recovery was getting at three different level was 103.33%, 89.78% and 86.63% and Specificity. The limit of detection and limit of quantification for Glimepiride were found to be 250 ng/spot and 500 ng/spot correspondingly. It is concluded from the results that the estimated High performance thin layer chromatography is economical, simple, reproducible, precise and accurate and it is useful in daily analysis in quality control depai iment for estimation of Glimepiride in Active pharmaceutical ingredient and Pharmaceutical dosage form. This method was validated as per ICH guideline Q2 (R1).