The Degradation Chemistry of Prasugrel Hydrochloride: Part 1-Drug Substance.

@article{Baertschi2019TheDC,
  title={The Degradation Chemistry of Prasugrel Hydrochloride: Part 1-Drug Substance.},
  author={Steven W. Baertschi and Lindsay Maxwell-Backer and Matthew Clemens and Tim A. Smitka and Jerry R Draper and Kenneth W. Taylor and Andreas Kaerner and Patrick J. Jansen},
  journal={Journal of pharmaceutical sciences},
  year={2019}
}
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References

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Study of the forced degradation behavior of prasugrel hydrochloride by liquid chromatography with mass spectrometry and liquid chromatography with NMR detection and prediction of the toxicity of the characterized degradation products.
TLDR
Toxicity prediction by computer-assisted technology (TOPKAT) and deductive estimation of risk from existing knowledge (DEREK) software were employed to assess in silico toxicity of the characterized degradation products.
IDENTIFICATION OF PRASUGREL (AN ANTIPLATELET DRUG) IMPURITIES BY LC-MS/MS, RAPID DETERMINATION OF PRASUGREL HYDROCHLORIDE-RELATED SUBSTANCES, AND DEGRADATION PRODUCTS IN ACTIVE PHARMACEUTICAL INGREDIENT AND PHARMACEUTICAL DOSAGE FORMS BY STABILITY INDICATING ULTRA-PERFORMANCE LIQUID CHROMATOGRAPHIC
A simple, sensitive, and reproducible gradient reverse-phase ultra-performance liquid chromatographic (UPLC) method was developed for the quantitative determination of Prasugrel and all possible…
Characterization of degradation products of amorphous and polymorphic forms of clopidogrel bisulphate under solid state stress conditions.
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The disposition and metabolism of prasugrel, a thienopyridine prodrug and a potent inhibitor of platelet aggregation in vivo, were investigated in mice, rats, and dogs and the main circulating thiol-containing metabolite in the three animal species is the pharmacologically active metabolite R-138727.
Stability-Indicating LC Method for the Determination of Prasugrel Hydrochloride in Pharmaceutical Dosage Form
A simple, rapid and precise method was developed for the quantitative estimation of prasugrel hydrochloride in pharmaceutical dosage form. A chromatographic separation of prasugrel and its degradants…
Mechanism of the Solution Oxidation of Rofecoxib Under Alkaline Conditions
TLDR
It is demonstrated that the rofecoxib anhydride species is actually the primary product of the oxidation reaction, and this work further investigates the mechanism of oxidation under the alkaline solution conditions.
COMPARATIVE STUDY OF FORCED DEGRADATION BEHAVIOR OF PRASUGREL BY UPLC AND HPLC AND THE DEVELOPMENT OF VALIDATED STABILITY INDICATING ASSAY METHOD
A novel stability-indicating ultra-performance liquid chromatographic (UPLC) assay method was developed and validated for prasugrel and its degradation products. The UPLC separation was performed on…
Stereoselective Metabolism of Prasugrel in Humans Using a Novel Chiral Liquid Chromatography-Tandem Mass Spectrometry Method
A liquid chromatography-tandem mass spectrometry method was developed to chromatographically separate the four stereoisomers of the active metabolite of prasugrel, R-138727, in human plasma after…
Determination of the active and inactive metabolites of prasugrel in human plasma by liquid chromatography/tandem mass spectrometry.
TLDR
Two fast and sensitive liquid chromatography/tandem mass spectrometry (LC/MS/MS) based bioanalytical assays were developed and validated to quantify the active and three inactive metabolites of prasugrel and showed accuracy and precision within +/-20% at the lower limit of quantification and +/-15% at other levels.
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