Abstract
STABILITY-INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF TENELIGLIPTIN HYDROBROMIDE HYDRATE AND METFORMIN HYDROCHLORIDE IN A COMBINED TABLET DOSAGE FORM

Anjani Mahesh Sharma*, Dr. Vandana Jain and Vidhya Raghunath Prabhu

ABSTRACT

The proposed research palimpsest describes a simple, accurate, precise and reproducible RP-HPLC method for simultaneous estimation of Teneligliptinhydrobromide hydrate (TEN) and Metformin hydrochloride (MET) in a combined tablet dosage form. Separation was achieved on Shimadzu shimpack C18 column (250 mm × 4.6 mm, 5 μ) using 50mM potassium dihydrogen orthophosphate (KH2PO4) buffer pH 3: Methanol (40:60) as mobile phase, at flow rate of 0.8mL/min. The UV detection wavelength was 254 nm. The linearity was obeyed over a concentration range of 10μg/ml to 30μg/ml for Teneligliptin hydrobromide hydrate and 250μg/ml to 750μg/ml for Metformin hydrochloride with correlation coefficient below 0.999. The proposed method was validated for its accuracy, precision, robustness and system suitability parameters. The developed method was statistically evaluated and %RSD was found to be less than 2 throughout the validation. Forced degradation was performed by subjecting the drugs to various stress conditions like acid, alkali, oxidation, photolytic, humidity and thermal degradation. The method was successfully employed for the simultaneous estimation of Teneligliptinhydrobromide hydrate and Metformin hydrochloride in a combined tablet dosage form and validated as per ICH guidelines.

Keywords: Teneligliptin hydrobromide hydrate, Metformin hydrochloride, RP-HPLC, Stability, Anti-diabetic.


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