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ISSN 2063-5346
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Establishment of Degradation behaviour of Metformin, Dapagliflozin and Saxagliptin by LC-Ms/Ms and prediction of their degradation pathways

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Juhi C. Sheth, DR. Ketan V. Shah
» doi: 10.48047/ecb/2023.12.si4.1024

Abstract

The present study examined the deterioration structures of Metformin, Dapagliflozin and Saxagliptin under varying levels of stress were studied regarding the ICH's (International Conference on Harmonization) guidelines. The degradation products and probable fragmentation mechanisms investigated using LC-MS/MS, a liquid chromatography-tandem mass spectrometry method. Methodology: The mobile phase was made up of isocratic elution, acetonitrile in a 70:30 volume ratio, and water containing 0.1% formic acid. For separation, an Agilent, Zorbax C18 column (150x4.6mm, 5 m) was chosen. The analysis of an ionization mass spectrophotometer used curtain gas flow at 20 psi and a source temperature of 400 C. By integrating column eluting into the apparatus for Q1 and MRM scan, drug fragments of metformin, dapagliflozin, and Saxagliptin were subjected to mass spectrometric analysis. Result: Metformin, Dapagliflozin, and Saxagliptin were shown to have retention times of 2.01, 6.1, and 3.95 minutes, accordingly. The calibration curve of peak region versus maintaining focus for metformin, dapagliflozin & Saxagliptin was linear in the vicinity of 0.5-1.5 g/ml with a r2 of 0.999. Different validation parameters were used, and the findings show that they are all within acceptable limits. Studies on force deterioration in various environments, including UV light, H2O2, acid, and base. Conclusion: It can be used to characterize the degradant products of metformin, dapagliflozin, and Saxagliptin. The proposed method was straightforward, exact, specific, robust, quick, and sensitive.

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