Forced Degradation Study of Vonoprazan Fumarate by HPLC and Characterisation of Its Degradation Products Using LC‐QTOF‐MS/MS
Abstract
RATIONALE: Acid-related disorders, including gastro-oesophageal reflux disease (GERD), peptic ulcers and Helicobacter pylori infection, affect millions worldwide. Vonoprazan fumarate, a potassium-competitive acid blocker, provides rapid and sustained acid suppression. Understanding its degradation behaviour is essential for ensuring drug stability, supporting formulation development and guiding quality control. METHODS: Vonoprazan fumarate was subjected to acidic and basic hydrolysis, oxidation, thermal and photolytic stress to evaluate its degradation behaviour. Degradation products were separated by reversed-phase high-performance liquid chromatography (HPLC) using a gradient program optimised for mobile-phase composition and flow rate, thereby enabling the chromatographic resolution of closely eluting degradation products. Structural characterisation was performed using liquid chromatography-quadrupole time-of-flight tandem mass spectrometry (LC-QTOF-MS/MS) based on accurate-mass measurements and diagnostic MS/MS dissociation patterns. The method was validated for linearity, precision, accuracy, selectivity and robustness. RESULTS: Nine degradation products were detected under stress conditions: Basic hydrolysis yielded degradation product (DP)-1 and DP-8; acidic stress produced DP-1, DP-2 and DP-4; oxidation generated DP-1, DP-2, DP-7 and DP-8; and photolysis formed DP-1 to DP-6, DP-8 and DP-9. Three degradation products exhibited identical protonated molecules and…
Read the paper
Related studies
- Protective effects of tadalafil and N-acetyl cysteine therapy on cisplatin-induced testicular toxicity
- The Use of Generative AI for Scientific Literature Searches for Systematic Reviews: ChatGPT and Microsoft Bing AI Performance Evaluation
- Sildenafil as a Candidate Drug for Alzheimer’s Disease: Real-World Patient Data Observation and Mechanistic Observations from Patient-Induced Pluripotent Stem Cell-Derived Neurons
- Ozone-modified properties of pumpkin seed oil as anti-H. pylori, anticancer, anti-diabetic and anti-obesity agent
- Effectiveness of Low-Intensity Extracorporeal Shock Wave Therapy in Erectile Dysfunction: An Analysis of Sexual Function and Penile Hardness at Erection: An Umbrella Review
- Molecular Docking of Silymarin as a Ligand for Aromatase Enzyme and HIV-1 Reverse Transcriptase Using Molegro Virtual Docker
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.