1Faculty of Quality Assurance, Parul University, Waghodia, Vadodara, Gujarat, 391760, India
2Department of Quality Assurance, Parul Institute of Pharmacy and Research, Parul University, Waghodia, Vadodara, Gujarat, 391760, India
3Department of Chemistry, Jai Research Foundation, Valsad, Gujarat 396105, India
Background: Bexagliflozin is a novel sodium-glucose transporter 2 inhibitor approved by FDA for treatment and management of type-2 diabetes mellitus. The suggested LC/MS-MS method is appropriate for quantification of bexagliflozin in dog plasma.
Purpose: To establish and validate LC-MS/MS method for the quantification of bexagliflozin in canine plasma as dog is a non-rodent animal model for preclinical research.
Materials and Methods: The protein precipitation method was employed for extraction of analyte from dog plasma. Chromatographic separation was accomplished utilizing Thermo BDS Hypersil column (150 mm x 4.6 mm, 5 µm) with a mobile phase consisting of methanol: acetonitrile (50:50) and 10 mM ammonium formate in milli-Q water in a ratio of 90:10 (v/v) for isocratic elution. The runtime was 3.5 mins at flow rate of 0.7 mL/min and the injection volume was fixed at 10 µL. Rolipram was used as internal standard.
Results: The validated method showed significant sensitivity and demonstrated linearity in the range of 10 – 1280 ng/mL. The accuracy of the method was found to be 94–108%, while precision was found to be less than 9%. Lower limit of quantification was determined to be 10.38 ng/mL and bexagliflozin showed recovery of about 101%.
Conclusion: A simple, precise and reproducible LC-MS/MS bioanalytical method using protein precipitation extraction was developed for estimation of bexagliflozin in dog plasma. This developed method would be further utilized to support pharmacokinetics studies of analyte in biological matrix.
Keywords: Bexagliflozin, LC-MS/MS, Protein Precipitation, Dog Plasma.
How to cite this article: Patel SJ, Mehta H, Ahmmad SB, Khan N. Validation and Stability Assessments of Novel LC-MS/MS Method for Quantitative Determination of Bexagliflozin in Dog Plasma. Int J Drug Deliv Technol. 2026;16(3): 1-7. DOI: 10.25258/ijddt.16.3.1
Source of support: Nil.
Conflict of interest: None