SIMULTANEOUS ESTIMATION OF SAXAGLIPTIN HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE IN ACTIVE PHARMACEUTICAL INGRIDENT BY RP-HPLC

NYOLA NARENDRA, GOVINDASAMY JEYABALAN

Abstract


A new simple, accurate, precise and reproducible RP-HPLC method has been developed for the simultaneous
estimation of Saxagliptin and Metformin in bulk drug form using C18 column (Phenomenex, 250 x 4.6 mm, 5 μm) in
isocratic mode. The mobile phase consisted of 0.02M Potassium dihydrogen phosphate (KH2PO4), Acetonitrile,
Methanol in the ratio of 50:25:25 (v/v/v) at pH 4.3. The detection wavelength was carried out at 240 nm. The
method was linear over the concentration range for Saxagliptin 10-50μg/ml and for Metformin 5-25 μg/ml. The
recoveries of Saxagliptin and Metformin were found to be 100.48and 101.1% respectively. The validation of method
was carried out utilizing ICH-guidelines. The described HPLC method was successfully employed for the analysis
of pharmaceutical formulations containing combined dosage form.


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