New Method Development and Validation of Bexagliflozin by UV- Visible Spectroscopy

The proposed analytical methods for estimating bexagliflozin in marketed formulations have successfully met the objectives of this research work. These methods are distinguished by their simplicity, rapidity, accuracy, and reproducibility, making them highly suitable for practical applications in pharmaceutical analysis. The established linear range of 5-25 μg/mL for bexagliflozin, coupled with correlation coefficients close to one, demonstrates the robustness and reliability of the proposed methods. This linearity is essential for ensuring that the method can accurately quantify bexagliflozin across a range of concentrations encountered in pharmaceutical formulations. The validation process for these methods included rigorous recovery studies, which yielded satisfactory results, indicating that the methods are capable of providing accurate and precise results in the analysis of bexagliflozin. These recovery studies involved spiking known amounts of the drug into the sample matrix and assessing the percentage of the drug that was recovered after analysis. The results confirmed that the methods can reliably measure bexagliflozin content, ensuring compliance with quality control standards. Furthermore, precision was evaluated through various parameters, including repeatability (intra-day precision), intermediate precision (inter-day precision), and reproducibility. The results from these evaluations demonstrated consistent and reliable performance of the methods; with low % RSD values indicating minimal variability in the results. This level of precision is critical in pharmaceutical analysis, where accurate dosing and quality assurance are paramount. Overall, the developed analytical methods for bexagliflozin not only fulfill the requirements for regulatory compliance but also provide a dependable tool for routine quality control in pharmaceutical settings.