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.pdf
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https://doi.org/10.31032/IJBPAS/2021/10.7.5536