ESTIMATION OF METFORMIN HYDROCHLORIDE AND TENELIGLIPTIN INPHARMACEUTICAL FORMULATION BY HIGH PERFORMANCETHIN LAYER CHROMATOGRAPHY

摘要

A new, accurate and precise high performance thin layer chromatographic (HPTLC) method has been developed for simultaneous analysis of metformin hydrochloride and teneligliptin in tablet formulation. The chromatographic separations were achieved on TLC plates precoated with silica gel G60 F254 and the plates were developed with 0.5% ammonium acetate-n propanol-ammonia (4.5:5:0.5, V/V/V) as mobile phase. Detection and evaluation of chromatograms were performed densitometrically at 252 nm. The retention factor of metformin hydrochloride and teneligliptin was found to be 0.2 and 0.63, respectively. The method was found to be linear in the range of 100-1200 ng per spot and 200-2400 ng per spot for metformin and teneligliptin, respectively. The method was validated with respect to precision, accuracy, specificity and robustness as per ICH guidelines Q2 (R1) and the results were found to be within the acceptance criteria. The method was successfully applied for the analysis of drugs in combined tablet dosage form.