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International Journal of Analytical Chemistry
Volume 2017, Article ID 2951529, 6 pages
https://doi.org/10.1155/2017/2951529
Research Article

In Vitro Dissolution Profile of Dapagliflozin: Development, Method Validation, and Analysis of Commercial Tablets

1Post-Graduation Program in Pharmaceutical Sciences, Department of Pharmacy, Universidade Estadual do Centro-Oeste (UNICENTRO), 85040-080 Guarapuava, PR, Brazil
2Department of Pharmacy, Federal University of Paraná, Curitiba, PR, Brazil

Correspondence should be addressed to Larissa Sakis Bernardi; moc.liamg@bs.assiral

Received 12 April 2017; Accepted 2 July 2017; Published 31 July 2017

Academic Editor: Troy D. Wood

Copyright © 2017 Rafaela Zielinski Cavalheiro de Meira et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Dapagliflozin was the first of its class (inhibitors of sodium-glucose cotransporter) to be approved in Europe, USA, and Brazil. As the drug was recently approved, there is the need for research on analytical methods, including dissolution studies for the quality evaluation and assurance of tablets. The dissolution methodology was developed with apparatus II (paddle) in 900 mL of medium (simulated gastric fluid, pH 1.2), temperature set at °C, and stirring speed of 50 rpm. For the quantification, a spectrophotometric ( nm) method was developed and validated. In validation studies, the method proved to be specific and linear in the range from 0.5 to 15 μg·mL−1 (). The precision showed results with RSD values lower than 2%. The recovery of 80.72, 98.47, and 119.41% proved the accuracy of the method. Through a systematic approach by applying Factorial 23, the robustness of the method was confirmed (). The studies of commercial tablets containing 5 or 10 mg demonstrated that they could be considered similar through , , and dissolution efficiency analyses. Also, the developed method can be used for the quality evaluation of dapagliflozin tablets and can be considered as a scientific basis for future official pharmacopoeial methods.