DEVELOPMENT AND VALIDATION OF STABILITY INDICATING REVERSED PHASE HIGHPRESSURE LIQUID CHROMATOGRAPHY METHOD FOR SIMULTANEOUS ESTIMATION OF METFORMIN AND EMPAGLIFLOZIN IN BULK AND TABLET DOSAGE FORM

Abstract

ABSTRACT Objective: To develop accurate, fast, simple, and precise reversed-phase high-pressure liquid chromatography method for simultaneous determination of the binary mixture of metformin (MET) and empagliflozin (EMPA) in dosage forms. Methods: The method uses a mobile phase consisting of phosphate buffer, acetonitrile, methanol (15:80:5 v/v/v), an octadecyl silica C-18 column (4.6 mm × 250 mm, 5 μ particle size) in isocratic mode, detection wavelength of 227 nm, and a flow rate of 1 mL/minutes. Results:  The  measured  retention  times  for  MET  and  EMPA  and  were  2.528  and  4.140 minutes,  respectively.  The  percentage  recoveries  of  MET  and  EMPA  were 101.12% and 100.55%, respectively. The relative standard deviation for assay of tablets was found to be <2%. The correlation coefficient for MET and  EMPA was found to be 0.9990. The limit of detection and quantification for MET was 0.10 µg/mL and 0.31 µg/mL and for EMPA 0.01 µg/mL and 0.03 µg/mL. Conclusion: The method was fast, accurate, precise, and sensitive hence it can be employed for routine quality control of tablets containing both drugs in quality control laboratories and pharmaceutical industries. Keywords: Empagliflozin, Forced degradation method, Metformin, Reversed-phase high-performance liquid, Stability-indicating assay.