Document Type
Article
Publication Date
3-2022
Abstract
Ipragliflozin degradation behavior was studied under different conditions: acidic, basic, photolytic, oxidative and thermal degradation conditions. This forced degradation study showed the extensive degradation of Ipragliflozin under acidic, basic and oxidative conditions while showed high stability under thermal and photo-degradation conditions. The separation of Ipragliflozin and its degradation products was done using Hypersil Gold® UPLC C18 column with 1.9 μm particle size (3 × 50 mm) as stationary phase and a mobile phase composed of acetonitrile: potassium monobasic phosphate buffer pH 3 (50:50; v/v) delivered at flow rate of 0.6 mL min−1. Validation of the proposed method was carried out in accordance to the International Council for Harmonisation’s guidelines. The method was found to be linear within the concentration range 5.0–50.0 µg mL−1 with a limit of detection of 1.48 µg mL−1. Accuracy was proven as the percentage recovery was 98.57 ± 0.40 and the percentage relative standard deviation was 0.82 which ascertained the precision. After chromatographic separation, mass characterization was used to structurally elucidate the degradation products and to propose the degradation pathway. Kinetics parameters of oxidative, acidic and basic degradation processes were determined and it was demonstrated that the degradation appears to follow a pseudo-first-order reaction. The simplicity and sensitivity of the proposed method promote its regular use in quality control laboratories.
Recommended Citation
Mowaka, Shereen; Elhassan,, Manar M.; Mahmoud, Amr M.; and Hegazy, Maha A., "Kinetic Degradation Study of Ipragliflozin Coupled with MS/MS Structural Elucidation" (2022). Pharmacy. 667.
https://buescholar.bue.edu.eg/pharmacy/667
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