DEVELOPMENT AND STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF METFORMIN HCL AND TENELIGLIPTIN HBR HYDRATE IN BULK AND PHARMACEUTICAL DOSAGE FORM

The objective of the current work is to develop a simple, efficient, economical and compatible RP-HPLC method for the analysis of Metformin HCL and Tenegliptin hydrobromide in bulk and pharmaceutical dosage form dosage forms. Samples were separated on Grace C8 (250mm x 4.6 id. particle size: 5 (micron) column with mobile phase composed of OPA and acetonitrile (pH 3.00) The method was carried out on Grace C8 (250mm x 4.6 i.d. particle size: 5 micron) using 0.1% OPA and acetonitrile in the ratio of 70:30 v/v with adjusted pH 3 at flow rate 0.9 mL/min. The wavelength of Metformin HCL and Teneligliptin HBr Hydrate at 246 nm was found to be appropriate. The linearity range was obtained in the concentration of 50-250 μg/mL Metformin HCL and 02-10 μg/mL Teneligliptin HBr Hydrate respectively. The retention time of Metformin HCL and Teneligliptin HBr Hydrate was found to be 2.395 ± 0.2 min and 2.891± 0.2 min respectively. The developed method was found be accurate, robust and sensitive which can be used for estimation of combination of Metformin HCL and Teneligliptin HBr Hydrate in bulk and pharmaceutical dosage form.

Keywords: Metformin HCL and Tenegliptin hydrobromide Phenomenex Grace C8 Column, Detection, RP HPLC