Abstract

QUANTITATIVE ANALYSIS OF LINAGLIPTIN IN ITS PHARMACEUTICAL DOSAGE FORM BY UV SPECTROSCOPY AND RP-HPLC TECHNIQUES

J.N. Suresh Kumar, B. Satya Prasad*, M. Keerthana, N. Varsha, P. Asha, T. Shantha Kumari, P. Vijay Babu

.

Abstract

Linagliptin, an oral anti-diabetic agent, stimulates insulin release to control blood glucose levels in Type-II diabetes mellitus. Existing methods analyzed Linagliptin and its related impurities in bulk and formulation by chromatographic techniques. Hence it was addressed to estimate Linagliptin commercial tablets (Trajenta) by simple, accurate, precise and economical validated methods including spectrophotometric and chromatographic techniques. The methods designed were calibration graph method (method-1), AUC method (method-2) and RP-HPLC method (method-3). For method -1 and method -2, 0.1M Hydro chloric acid was used as solvent and analytical wavelength was at 295 nm and 290-300nm respectively. For method-3, Stationary phase used was phenomenex C18 column and mobile phase constituted acetonitrile: phosphate buffer-8 (0.02M) (60:40) at flow rate of 1ml/min with UV detection at 299nm. The developed three methods demonstrated good linearity with R2>0.999 in the concentration range of 5-25 μg/ml (method-1 and method-2) and 20-40 μg/ml (method-3). Accuracy values were 100.68% (method-1) 98.86% (method-2) and 101.22% (method-3). Precision results were decorous & within limits for 3 methods (%RSD

Keywords: Linagliptin, Calibration graph method, AUC method, RP-HPLC, Validation and Dissolution.