Abstract

DEVELOPMENT AND VALIDATION OF LC-MS/MS METHOD FOR QUANTIFICATION OF TENELIGLIPTIN IN HUMAN PLASMA AND ITS APPLICATION TO A PHARMACOKINETIC STUDY

Raja Haranadha Babu Chunduri* and Gowri Sankar Dannana

ABSTRACT

A selective, sensitive and rapid liquid chromatographic method with electro spray ionization tandem mass spectrometric detection has been developed and validated for quantification of teneligliptin in human plasma using repaglinide as internal standard (IS). The analytes and IS were extracted from 50 μL of plasma by liquid-liquid extraction technique using methyl tert - butyl ether which offers high sensitivity, wide linearity without interferences form endogenous matrix components. In a short chromatographic run of 1.50 min run time, separation was achieved on a Hypersil Gold C18 column using a mobile phase composed of 0.1% formic acid in Milli-Q water/0.1% formic acid in acetonitrile in gradient elution mode. The quantification of teneligliptin was performed in a positive electro spray ionization mode and multiple reaction monitoring (MRM). Response was a linear function of concentration in the ranges of 0.1 to 4000 ng/mL for teneligliptin with r2> 0.99. The intra- and inter-day precision and accuracy results were below 15% and acceptable as per Food and Drug Administration (FDA) guidelines. Stability of teneligliptin was established in a battery of stability studies, i.e. bench top, auto sampler and long term storage stability as well as freeze thaw cycles. The validated method can be used as a routine method to support pharmacokinetic studies.

Keywords: Teneligliptin; LC-MS/MS.