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VOL. 8, ISSUE 2 (2023)
Bioanalytical method development for dapagliflozin and saxagliptin by RP-HPLC method
Authors
Chaitrashree N, Tanuja A J, Chetan M B, Hanumanthachar Joshi
Abstract
The simultaneous quantification of Dapagliflozin and Saxagliptin in rat plasma, a straightforward, precise, quick, and accurate RP-HPLC method was created. By using methanol as a solvent and the protein precipitation method, the drug samples were extracted. The separation was achieved by using C-8 Eclipse plus(5µ particle size, 250×4.6mm,5µm internal diameter). The mobile phase comprises of 0.01% Trimethylamine in water and Methanol in the ratio of 40:60(v/v). The flow rate was 1.0ml/min and the effluents were monitored at 228 nm with a total run time of 15min. The retention time was found to be 4.243 and 11.304 respectively for Saxagliptin and Dapagliflozin. The detection concentration was linear over 25- 175ng/ml for Saxagliptin and Regression equation was found to be y =852.37x+3836with regression coefficients 0.9932 and percentage recovery of 99.96%.The detection concentration was linear over 100-700ng/ml for Dapagliflozin and Regression equation was found to be y=132.88x+322.9 with regression coefficients 0.9902 and percentage recovery of 99.80%. The liquid chromatography method was extensively validated for linearity, accuracy, precision and recovery. The developed approach was successfully shown for the simultaneous determination of Saxagliptin and Dapagliflozin in rat plasma and verified in accordance with ICH criteria. All these analytical validation parameters were found to be satisfactory. For the examination of rat plasma for use in pharmacokinetic studies, pharmacological interactions, bio availability, and bio equivalence, this method is therefore conveniently applicable.
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Pages:7-12
How to cite this article:
Chaitrashree N, Tanuja A J, Chetan M B, Hanumanthachar Joshi "Bioanalytical method development for dapagliflozin and saxagliptin by RP-HPLC method". International Journal of Research in Pharmacy and
Pharmaceutical Sciences, Vol 8, Issue 2, 2023, Pages 7-12
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