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Stability-indicating HPLC Method for Simultaneous Determination of Aspirin and Prasugrel
Shital M Patel1, C N Patel, V B Patel
1Department of Quality Assurance, Shri Sarvajanik Pharmacy College, Mehsana-384 001, India.
Indian Journal of Pharmaceutical Sciences
|December 5, 2013
Summary
A new high-performance liquid chromatography method accurately determines aspirin and prasugrel simultaneously. This stability-indicating assay effectively quantifies these drugs in various conditions and formulations.
Area of Science:
- Analytical Chemistry
- Pharmaceutical Analysis
Background:
- Aspirin and prasugrel are commonly prescribed antiplatelet medications.
- Accurate quantification and stability assessment are crucial for pharmaceutical quality control.
Purpose of the Study:
- To develop and validate a simple, sensitive, and specific stability-indicating reversed-phase high-performance liquid chromatographic (RP-HPLC) method.
- To enable the simultaneous determination of aspirin and prasugrel in bulk drugs and pharmaceutical formulations.
Main Methods:
- Utilized a Kromasil 100 C18 column (150 × 4.6 mm, 5 μm).
- Employed a mobile phase of acetonitrile:methanol:water (30:10:60, v/v) at pH 3.0, adjusted with o-phosphoric acid.
- Investigated drug stability under various stress conditions including acid, alkali, neutral hydrolysis, oxidation, dry heat, and UV exposure.
Main Results:
- Achieved distinct retention times for aspirin (3.28 min) and prasugrel (6.61 min).
- Demonstrated linearity for aspirin (15-150 μg/ml) and prasugrel (2-20 μg/ml).
- Reported high percentage recoveries for both drugs (aspirin: 99.34-100.32%; prasugrel: 98.92-102.09%).
- Identified differential susceptibility to degradation: aspirin to alkaline hydrolysis, prasugrel to neutral hydrolysis.
- Ensured excellent resolution between degradation products and parent drugs.
Conclusions:
- The developed RP-HPLC method is simple, sensitive, specific, accurate, and stability-indicating.
- The method is suitable for the simultaneous quantitative analysis of aspirin and prasugrel in bulk and finished pharmaceutical products.
- The method effectively differentiates between the drugs and their degradation products, crucial for stability studies.
