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International Journal of Pharmaceutical Chemistry and Analysis


High performance thin layer chromatographic determination of linagliptin in pharmaceutical formulations and in biological samples


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Author Details: RP Bhole, SB Wankhede, YB Zambare, TS Wankhede

Volume : 4

Issue : 1

Online ISSN : 2394-2797

Print ISSN : 2394-2789

Article First Page : 13

Article End Page : 19


Abstract

A HPTLC method was developed and validated for determination of Linagliptin in tablet formulation and in biological sample. The chromatography was performed on pre-coated silica gel 60 F254 plates using methanol: toluene 7:3 (v / v) as mobile phase. The optimized chromatographic conditions gave good peak shape with acceptable Rf value of 0.48 for Linagliptin. Method was validated as per ICH guidelines. The calibration plots were linear between 50–300 ng/ band and between 50-500 ng/ band in pure and in biological sample, respectively. Accuracy of the proposed method was evaluated by recovery studies (% recovery= 100.38 % and 99.99 % from tablet sample and biological sample, respectively). In stability testing, Linagliptin was found susceptible to acid hydrolysis, alkali hydrolysis and oxidation (3 % H2O2). The method was able to selectively quantitative. Linagliptin in presence of degradation products and components likely to be present in the biological matrix.

Keywords:
Linagliptin, high performance thin layer chromatography, Method development, Validation, Pharmaceutical formulation, Biological sample