alexa Abstract | Development and validation of thin layer chromatography-densitometry method for determination of glimepiride in tablets

Journal of Chemical and Pharmaceutical Research
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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 F254 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 %.

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Author(s): Harrizul Rivai Vera Wahyuni Adha and Fitra Fauziah

Keywords

Glimepirida, thin layer chromatography, densitometry, validation, chromatography

 
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