SIMULTANEOUS ESTIMATION AND ANALYTICAL METHOD DEVELOPMENT, VALIDATION FOR THE TENELIGLIPTIN AND METFORMIN BY RP-UFLCAbstract
The study aims to develop an analytical method for the simultaneous estimation of Teneligliptin and Metformin using RP-UFLC. A simple, sensitive and accurate method was developed for Teneligliptin and Metformin using the chromatographic conditions of C18 Phenomenex Kinetex (250 mm × 4.6 mm i.e., 5 μm particle size) column in gradient elution mode with the mobile phase consisting of methanol, acetonitrile and potassium dihydrogen orthophosphate adjusted to pH 4.6 using orthophosphoric acid (40:20:40) with a flow rate of 1.0 mL/min, injection volume 10 µl and the eluent was detected at 250 nm using PDA and UV detector. The retention time of Teneligliptin and Metformin were found to be 5.2 min and 2.5 min respectively. The above method was validated concerning system suitability, linearity, precision, limit of detection (LOD) and limit of quantification (LOQ), accuracy (recovery) and robustness according to ICH guidelines. The linearity of the above methods was found to be 2-10 µg/mL for Teneligliptin and 25-125 µg/mL for Metformin. Hence, these methods can be used for routine analysis in quality control laboratories.
R. Maruthi *, R. S. Chandan and P. Raikar
Department of Pharmaceutical Chemistry, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Mysuru, Karnataka, India.
28 July 2018
03 October 2018
19 November 2018
01 April 2019