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.Downloads
Published
01-08-2016
How to Cite
Swarupa P, G., L. Rao K, P. KRS, and S. Babu K. “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”. Asian Journal of Pharmaceutical and Clinical Research, vol. 9, no. 7, Aug. 2016, pp. 126-35, https://journals.innovareacademics.in/index.php/ajpcr/article/view/12614.
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