1*,2School of Pharmaceutical Sciences, Sandip University, Nashik, Maharashtra, India.
*Corresponding Author: Sachin K. Hodgar, Email: skh.vniprc@gmail.com, deoresumit@gmail.com
Background: The presence of related impurities in pharmaceutical formulations can significantly impact drug safety and efficacy, making their accurate determination essential. The present study focuses on the development and validation of a reverse-phase high-performance liquid chromatography (RP-HPLC) method for the analysis of related impurities in Dapagliflozin.
Methods: Chromatographic separation was achieved using a C18 column with an optimized mobile phase under isocratic conditions, and detection was carried out using a UV detector. The developed method was validated in accordance with International Council for Harmonisation guidelines for parameters such as specificity, linearity, accuracy, precision, robustness, limit of detection, and limit of quantification.
Results: The results demonstrated that the method is precise, accurate, and capable of effectively separating the drug substances from their related impurities.
Conclusion: Therefore, the proposed RP-HPLC method is suitable for routine quality control and stability studies of these antidiabetic drugs.
Key Words: C18 column, RP-HPLC, Dapagliflozin, UV detector
How to cite this article: Hodgar SK, Deore SR. Method Development and Validation for Related Impurities of Dapagliflozin. Int J Drug Deliv Technol. 2026;16(2): 637-646. DOI: 10.25258/ijddt.16.2.68
Source of support: Nil.
Conflict of interest: None