Key result
New RP-HPLC method reliably separates Aspirin and Apixaban with at least ~90% recovery.
Why the study?
A robust RP-HPLC method was needed for the simultaneous determination of Aspirin and Apixaban in bulk and in-house capsule formulations.
A robust and validated RP-HPLC method was developed for the simultaneous determination and quality control of Aspirin and Apixaban in pharmaceutical formulations.
Validated RP-HPLC method aids Aspirin-Apixaban quality control; leaves open clinical translation.
OBJECTIVES: This study aimed to develop a robust Reverse Phase-High-Performance Liquid Chromatography (RP-HPLC) method for simultaneous determination of Aspirin (ASP) and Apixaban (API) in bulk and in-house capsule formulations. METHODS: column using a Shimadzu LC20AT High-performance liquid chromatography (HPLC) system. The mobile phase consisted of 40:60 Acetonitrile (ACN): phosphate buffer (pH 4) modified by O-Phosphoric Acid (OPA). The parameters included a flow rate of 1 ml/min, a column temperature of 30°C, and Ultra-Violet (UV) detection at 227 nm. Method validation encompassed linearity, precision (Intraday and Interday), accuracy (% Recovery), and sensitivity (Limit of Detection (LOD) and Limit of Quantification (LOQ)). Stability testing followed The International Council for Harmonization (ICH) guidelines. RESULTS: The developed method demonstrated reliable separation of Aspirin and Apixaban with retention times of 5.37 min and 7.10 min, respectively. It exhibited linearity over the concentration ranges of 50-300 μg/mL for Aspirin and 5-15 μg/mL for Apixaban. The recovery percentage ranged from 90.02% to 101% for Aspirin and 98.18% to 101.18% for Apixaban. LOD and LOQ were determined as 0.84 μg/mL and 2.55 μg/mL for Aspirin, and 0.41 μg/mL and 1.24 μg/mL for Apixaban, respectively. Stability testing confirmed the method's robustness under various stress conditions. CONCLUSIONS: The validated RP-HPLC method offers a reliable tool for routine analysis of Aspirin and Apixaban in pharmaceutical formulations, highlighting its potential for combined dosage applications and routine quality control.
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Tarang Patel (2024) studied this question. RP-HPLC method for Aspirin and Apixaban was evaluated on Method validation (recovery percentage). The developed RP-HPLC method demonstrated reliable separation of Aspirin and Apixaban with recovery percentages ranging from 90.02% to 101% for Aspirin and 98.18% to 101.18% for Apixaban.
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