---

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

Full Text PDF

---

Original Article

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

Volume : 4, Issue : 1, Year : 2017

Article Page : 13-19

Suggest article by email

Get Permission

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 R_f 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

How to cite : Bhole R, Wankhede S, Zambare Y, Wankhede T, High performance thin layer chromatographic determination of linagliptin in pharmaceutical formulations and in biological samples. Int J Pharm Chem Anal 2017;4(1):13-19

This is an Open Access (OA) journal, and articles are distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as appropriate credit is given and the new creations are licensed under the identical terms.