RP-HPLC METHOD DEVELOPMENT AND VALIDATION OF METFORMIN, DOPAGLIFLOZIN, SAXAGLIPTIN IN TABLET DOSAGE FORMS

Abstract

A SIMPLE, ACCURATE, PRECISE METHOD WAS DEVELOPED FOR THE SIMULTANEOUS ESTIMATION OF THE
METFORMIN, DAPAGLIFLOZIN AND SAXAGLIPTIN IN PHARMACEUTICAL DOSAGE FORM. CHROMATOGRAM
WAS RUN THROUGH ZORBAX C18 250X4.6MM, 5 . MOBILE PHASE CONTAINING 0.01N KH2PO4AND
ACETONITRILE IN THE RATIO OF 55:45 V/V WAS PUMPED THROUGH COLUMN AT A FLOW RATE OF
1.0ML/MIN. TEMPERATURE WAS MAINTAINED AT 30°C. OPTIMIZED WAVELENGTH FOR
METFORMIN. DAPAGLIFLOZIN AND SAXAGLIPTIN WAS 230.0 NM. RETENTION TIME OF
SAXAGLIPTIN, METFORMIN AND DAPAGLIFLOZIN WERE FOUND TO BE 2.253MIN, 2.701MIN AND
3.598MIN. %RSD OF SYSTEM PRECISION FOR METFORMIN,
SAXAGLIPTINANDDAPAGLIFLOZINWEREANDFOUNDTOBE1.1,1.7AND1.1RESPECTIVELY.%RSDOFM
ETHOD PRECISION FOR METFORMIN, SAXAGLIPTIN AND DAPAGLIFLOZIN WERE AND FOUND TO
BE 0.8, 1.1 AND 0.6 RESPECTIVELY. % RECOVERY WAS OBTAINED AS 98.94%, 100.35% AND 100.13%
FOR METFORMIN,
SAXAGLIPTINANDDAPAGLIFLOZINRESPECTIVELY.LODVALUESAREOBTAINEDFROMREGRESSION
EQUATIONSOF
METFORMIN,SAXAGLIPTINANDDAPAGLIFLOZIN.WERE4.50PPM,0.02PPM,0.10PPMANDLOQVALUESA
RE OBTAINED FROM REGRESSION EQUATIONS OF METFORMIN, SAXAGLIPTIN AND
DAPAGLIFLOZIN WERE 13.65PPM, 0.05PPM ,0.31PPM RESPECTIVELY. REGRESSION EQUATION OF
METFORMIN WAS Y = 5934X + 13728., DAPAGLIFLOZIN WAS Y = 119948X + 2393.4.AND OF
SAXAGLIPTIN WAS Y = 101914X + 5013. RETENTION TIMES ARE DECREASED SO THE METHOD
DEVELOPED WAS SIMPLE AND ECONOMICAL THAT CAN BE ADOPTED IN REGULAR QUALITY
CONTROL TEST ININDUSTRIES.