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Stability-indicating RP-HPLC-DAD method for aspirin and vonoprazan using analytical quality by design and
Meghana Ajmeera1, Sravya Goli1, Pallavi Alegete1
1Department of Analytical and Structural Chemistry, CSIR-Indian Institute of Chemical Technology, Hyderabad 500007, India; Academy of Scientific and Innovative Research (AcSIR), Ghaziabad 201002, India.
A new analytical method accurately quantifies aspirin and vonoprazan in combination therapy, ensuring gastrointestinal safety. This method is stable-indicating and environmentally friendly for quality control.
Area of Science:
- Analytical Chemistry
- Pharmaceutical Sciences
- Drug Development
Background:
- Fixed-dose combination therapy of aspirin and vonoprazan is crucial for patients needing long-term antiplatelet treatment with reduced gastrointestinal risks.
- Effective and reliable analytical methods are essential for quality control and stability assessment of such pharmaceutical combinations.
Purpose of the Study:
- To develop and validate a robust, stability-indicating RP-HPLC method for the simultaneous quantification of aspirin (ASP) and vonoprazan fumarate (VPZ).
- To assess the environmental impact and practical feasibility of the developed analytical method for routine quality-control applications.
Main Methods:
- Method development involved Failure Mode Effects Analysis (FMEA) and optimization using a face-centered central composite design (FCCD).
- Chromatographic separation was achieved on a Zorbax SB-C18 column using isocratic elution with a water-acetonitrile-formic acid mobile phase.
- Stability-indicating specificity was confirmed through forced degradation studies (ICH Q1A(R2)), and degradation products were characterized using LC-MS/MS.
Main Results:
- The RP-HPLC method provided baseline resolution of ASP and VPZ within 8.5 minutes at 280 nm, with confirmed peak purity via DAD spectral analysis.
- Forced degradation studies demonstrated the method's stability-indicating nature, identifying key degradation pathways for vonoprazan, including hydroxylation and N-oxidation.
- Comprehensive environmental assessment tools (GAPI, AGREE, Eco-Scale, ChlorTox, BAGI, CACI) indicated favorable environmental compatibility and practical feasibility.
Conclusions:
- A validated, stability-indicating RP-HPLC method is suitable for the routine quality control of aspirin and vonoprazan fixed-dose combinations.
- The developed method is robust, specific, and demonstrates good environmental compatibility, supporting its practical application in pharmaceutical analysis.
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