ABSTRACT

The Novel, Convenient, sensitive, accurate and precise reverse phase high performance liquid chromatography technique has been established for simultaneous estimation of Metformin and Dapagliflozin in pharmaceutical dosage form. On an Agilent C18 column (250mm x 4.6mm, 5?m), isocratic flow was used to produce the separation. Methanol and 0.05 % orthophosphoric acid buffer (70:30 v/v) make up the mobile phase, which flow rate of 1 ml/min at 233 nm, the wavelength detection was done. The retention times for Metformin and Dapagliflozin utilizing the described approach were determined to be 2.289 and 5.576 minutes, respectively. A linear response was observed over the concentration range 1-5?g/ml for Dapagliflozin and 50-250?g/ml for Metformin. The correlation coefficient was found to 0.999 for both Dapagliflozin and Metformin. The precision of the proposed method was found to be 0.175% for Metformin and 0.835 for Dapagliflozin in intraday precision and 0.083% for Metformin and 0.389% for Dapagliflozin in inter day precision. The percentage recoveries for Metformin and Dapagliflozin were reported to be between 98.21 and 101.06 and 98.45 and 101.68%, respectively. LOD and LOQ for Metformin were found to be 1.1942 ?g/ml and 3.6187 ?g/ml, and for Dapagliflozin were found to be 0.05651 ?g/ml and 0.17126 ?g/ml respectively. The % test result of Metformin and Dapagliflozin were found to be 100.47% and 99.38% respectively. All the parameter of validation were in the acceptable range Result of validation parameters demonstrated that the analytical procedure is suitable for its intended purpose and meets the criteria defined in ICH Q2R1. Keywords: Dapagliflozin, Metformin, RP-HPLC, Method Development, Validation, ICH Q2R1
Publication date: 01/10/2023

https://ijbpas.com/pdf/2023/October/MS_IJBPAS_2023_7377.pdf

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https://doi.org/10.31032/IJBPAS/2023/12.10.7377