Abstract

IDENTIFICATION AND QUANTIFICATION OF LINAGLIPTIN IN PHARMACEUTICAL PREPARATION BY HIGH PERFORMANCE LIQUID CHROMATOGRAPHY

Suraj Sahoo*, Suman Kumar Mekap, Monalisa Mahapatra, Rasmita Jena and Deepak Sarangi

Abstract

A high performance liquid chromatography (HPLC) procedure was developed for Linagliptin, a dipeptidyl peptidase-4 inhibitor. The present work is optimised to develop simple, economic procedure which is linear, precise, accurate and robust. Identification was executed by HPLC using mobile phase that consist of 0.1 % percholric acid, acetonitrile and methanol in the ratio of 65:35:10 v/v at a flow rate of 1.2 ml/min with detection at 235 nm by Ultraviolet detector. The retention time noted is 3.7 minutes. Linearity results with correlation coefficient value of 0.999 to get calibration curve holds good agreement between different concentration levels and detector response. The % RSD values under precision obtained for method precision and intermediate precision are 0.3 and 0.5 respectively. There exists a good agreement among amount recovered (99.6 -100.4%) at different levels. The % RSD values obtained for robustness under change in organic solvent, flow rate detection and wavelength are 0.8, 0.2 and 0.7 respectively. The validation results obtained are within the acceptance criteria laid down by ICH. The present procedure can be applied for the identification of Linagliptin in tablet dosage form in routine laboratory works.

Keywords: Linagliptin, HPLC, Ultraviolet, Validation, ICH.