Analytical method development and validation of prasugrel in bulk and its pharmaceutical formulation using the...

Area of Science:

• Analytical Chemistry
• Pharmaceutical Analysis

Background:

• Prasugrel is an antiplatelet medication.
• Accurate quantification of prasugrel is crucial for pharmaceutical quality control.

Purpose of the Study:

• To develop and validate a simple, sensitive, precise, and specific reverse phase high-performance liquid chromatographic (HPLC) method.
• To determine prasugrel in bulk and tablet dosage forms.

Main Methods:

• Reverse phase HPLC using an Inertsil ODS-3V column.
• Mobile phase: water:acetonitrile (30:70 v/v) with phosphate buffer.
• Detection at 210 nm.

Main Results:

• Linear calibration curve for prasugrel (100-600 μg/ml).
• High sensitivity: Limit of Detection (LOD) 0.25 μg/ml, Limit of Quantification (LOQ) 0.75 μg/ml.
• Excellent accuracy (99.8-101.2% recovery) and precision.

Conclusions:

• The developed HPLC method is simple, fast, accurate, and precise.
• Suitable for routine quality control analysis of prasugrel in bulk and dosage forms.