Available online www.jocpr.com Journal of Chemical and Pharmaceutical Research, 2016, 8(3):841-848 Research Article ISSN : 0975-7384 CODEN(USA) : JCPRC5 841 Development and validation of thin layer chromatography-densitometry method for determination of glimepiride in tablets Harrizul Rivai 1* , Vera Wahyuni Adha 2 and Fitra Fauziah 2 1 Faculty of Pharmacy, University of Andalas, Padang 25163, Indonesia 2 College of Pharmacy, Jl. Tamansiswa No. 9, Padang 25132, Indonesia _____________________________________________________________________________________________ ABSTRACT A simple, selective and accurate thin layer chromatography (TLC)-densitometry method has been developed and validated for analysis of glimepiride in tablets. Glimepiride assay was performed by TLC-densitometry using silica gel 60 F 254 plates as the stationary phase and a mixture of chloroform : methanol (9 : 1) as the best mobile phase. Standard solution of glimepiride in the range of 100-500 ppm resulted in a regression equation y = 1221.03 + 17.9959x with r = 0.9973. Glimepiride detection limit was 44.10598 ppm and the limit of quantification of glimepiride was 133.6545 ppm. Accuracy was obtained percent recovery for glimepiride was 101.19 % ± 2.67 % for Metrix ® (PT Kalbe Farma) and 100.86 % ± 1,83 % for generic tablet (PT Dexa Medica). Precision intraday and interday had good repeatability as RSD ≤ 2 %. The analysis showed levels of glimepiride on a generic tablet of 104.68 % ± 0.50 % and glimepiride tablets under the trade name of 104.49 % ± 0.60 %. The levels glimepiride obtained have suitably qualified Indonesian Pharmacopoeia edition V, i.e. 90-110 %. Keywords: Glimepirida, thin layer chromatography, densitometry, validation _____________________________________________________________________________________________ INTRODUCTION Glimepiride (Fig. 1) is a derivative sulfonylurea class of drugs, with the chemical name 1-[[p-[2-(3-ethyl-4-methyl- 2-oxo-3pyrolin-1-carboxamido) ethyl] phenyl] sulfonyl]-3-(trans-4-methyl-cyclohexyl) urea [1]. Metformin- glimepiride tablets resulted in significantly greater reductions in glycosylated hemoglobin and fasting plasma glucose compared with metformin plus glibenclamide in patients with type 2 diabetes mellitus [2]. Glimepiride monotherapy markedly improved a rapid homeostatic model assessment (HOMA-R) with moderate insulin stimulation, which may account for the difference in macro vascular disease development as compared with the group receiving glibenclamide [3]. Fig. 1: Chemical structure of glimepiride Later this as an antidiabetic drug use is increasing, because of the benefits that a low therapeutic dose and risk of hypoglycemia effect is smaller compared to other sulfonylurea class. Glimepiride has a long-term action with a half-