ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF TENELIGLIPTIN HYDROBROMIDE HYDRATE ACTIVE PHARMACEUTICAL INGREDIENT BY USING RP-HPLC Authors: G Srikanth Reddy , V SWETHA, B VENU G AND J PAVANI
ABSTRACT
Teneligliptin Hydrobromide Hydrate is an Anti-Diabetic drug used in the treatment of Diabetes.
From the literature survey it was found that many methods are available for determination assay
of Teneligliptin Hydrobromide Hydrate. In the proposed study an attempt will be made to
develop HPLC for the estimation of related substances. In HPLC the chromatographic separation
was achieved with L1 stationary phase (YMC Triart C18 150 x 4.6mm; 3?m). The mobile phase
involved a variable composition of solvent A (Buffer: Acetonitrile: Methanol (50:40:10) %
v/v/v), solvent B (Acetonitrile:water in the ratio of 80:20 v/v). The mobile phase was pumped
through the column with at a flow rate of 1ml/min. The detection was carried out at wavelength
210nm and column oven temperature at 45°C, the method was established from the peak purity
induces obtained with the aid of PDA detection. Regression analysis shows an 'r' value
(correlation coefficient) is 0.999 for Teneligliptin Hydrobromide Hydrate in both HPLC.
Robustness against small modification column oven temperature, flow rate and percentage of the Publication date: 01/07/21 https://ijbpas.com/pdf/2021/July/MS_IJBPAS_2021_5536.pdfDownload PDFhttps://doi.org/10.31032/IJBPAS/2021/10.7.5536