Abstract

BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF TENELIGLIPTIN USING RP-HPLC IN RABBIT PLASMA

Nallakumar P.* and Siva Kumar R.

Abstract

A simple, highly sensitive, precise and accurate high-performance liquid chromatographic (HPLC) method was developed and validated for the determination of teneligliptin in rabbit plasma samples. The chromatographic separation was achieved with a reverse phase column thermo C18 (4.6×100 mm, 5μ) and the mobile phase consisted of methanol and 5mm potassium phosphate buffer (60:40 v/v) at a flow rate of 1mL/min. Sitagliptin was used as an internal standard. The retention time of Teneligliptin and sitagliptin were found to be 3.9 and 2.2min respectively. The calibration curve was linear (r2 > or = 0.99) ranging from 7.20 to 470ng/ml and the lower limit of quantification was 7.20 ng/mL. Interday precision were lower than 5% (CV) and accuracy ranged from 90 to 110% in terms of percent accuracy. Mean extraction recovery was found to be above 82%. The method was successfully developed and validated in rabbit plasma for excellent selectivity, accuracy, precision, recovery and stability.

Keywords: HPLC; Teneligliptin; internal standard, Rabbit plasma; Validation.