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Annals of Pharmacy Practice and Pharmacotherapy

2021 Volume 1
Creative Commons License

Development of an RP-HPLC Method for Dapagliflozin and Metformin HCL Analysis


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  1. Department of Pharmaceutical Analysis, RBVRR Women’s College of Pharmacy, Affiliated to Osmania university, Barkatpura, Hyderabad, Telangana-500027, India.
Abstract

The present study aimed to investigate the RP-HPLC method for the determination of dapagliflozin and metformin HCl in bulk and combined formulation. For this purpose, the provided RP-HPLC approach was found to be straightforward, precise, specific, and cost-effective. The phase of stationary Chromatographic conditions was Phenomenex C18 250 x 4.6 mm. A 50:50 water: methanol ratio was employed as the fluid phase. The wavelength of observation was 230 nm, the diluent was water, and the flow rate was kept at 51.0 ml/min at a column temperature of 300 °C. Finally, the conditions were completed as an optimal process. Appropriate system variables were investigated by applying the standard six times, and the results were significantly below the approval standards: the linearity of metformin HCl was found to be 2-7 ppm, while the linearity of dapagliflozin was discovered to be 60-210 ppm with r2 = 0.999; the precision values for them were 0.8214% and 0.6342%, respectively. The results showed that the LOD and LOQ values for metformin HCl were 263000 and 324000 ppb, respectively, while for dapagliflozin they were 345000 ppb and 415000 ppb. Using the foregoing procedure, the formulated market was assessed, and the percentages of metformin HCl and dapagliflozin were determined to be 99.85% and 99.73%, respectively.


How to cite this article
Vancouver
Bhavyasri K, Surekha T, Begum S, Sumakanth M. Development of an RP-HPLC Method for Dapagliflozin and Metformin HCL Analysis. Ann Pharm Pract Pharmacother. 2021;1:31-8.
APA
Bhavyasri, K., Surekha, T., Begum, S., & Sumakanth, M. (2021). Development of an RP-HPLC Method for Dapagliflozin and Metformin HCL Analysis. Annals of Pharmacy Practice and Pharmacotherapy, 1, 31-38.

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