Concurrent Estimation of Clopidogrel Bisulfate and Aspirin in Tablets by Validated RP-HPLC Method

Area of Science:

• Analytical Chemistry
• Pharmaceutical Analysis

Background:

• Cardiovascular diseases require combination therapy with drugs like aspirin and clopidogrel bisulfate.
• Accurate quantification of these active pharmaceutical ingredients in dosage forms is crucial for therapeutic efficacy and patient safety.

Purpose of the Study:

• To develop and validate a simple, rapid, and precise reversed-phase high-performance liquid chromatography (RP-HPLC) method.
• To enable simultaneous estimation of aspirin and clopidogrel bisulfate in tablet dosage forms.

Main Methods:

• RP-HPLC was employed using a mobile phase consisting of acetonitrile, potassium dihydrogen phosphate buffer, and methanol (50:30:20, v/v) at pH 3.
• Separation was achieved at a flow rate of 1.5 ml/min with detection at 240 nm.

Main Results:

• The method provided good separation of aspirin and clopidogrel bisulfate, eluting at 2.2 min and 7.47 min, respectively.
• Linearity was established in the concentration ranges of 1.5-7.5 μg/ml for aspirin and 3.5-15.0 μg/ml for clopidogrel bisulfate.
• All analytical validation parameters met ICH guidelines, confirming method reliability.

Conclusions:

• The developed RP-HPLC method is suitable for the simultaneous quantification of aspirin and clopidogrel bisulfate in tablet formulations.
• This validated method offers a reliable tool for quality control in pharmaceutical manufacturing of cardiovascular drugs.