Automated analysis of warfarin sodium tablets

Area of Science:

• Pharmaceutical analysis
• Analytical chemistry
• Drug quality control

Background:

• The United States Pharmacopeia (USP) manual procedure is the standard for warfarin sodium determination.
• Manual assays can be time-consuming and labor-intensive.
• Automation offers potential improvements in efficiency and consistency for pharmaceutical testing.

Purpose of the Study:

• To develop and validate an automated procedure for warfarin sodium determination.
• To ensure the automated method meets the standards of the manual USP procedure.
• To assess the applicability of the automated method for various sample types and concentrations.

Main Methods:

• Development of an automated analytical procedure based on the manual USP method.
• Testing the automated procedure with single warfarin sodium tablets and composites of 20 tablets.
• Evaluation of sensitivity, precision, accuracy, and reproducibility.

Main Results:

• The automated procedure demonstrated equivalent sensitivity, precision, accuracy, and reproducibility to the manual USP method.
• Sensitivity was determined to be approximately 15 µg/ml.
• The coefficient of variation was 0.711%, indicating high precision.

Conclusions:

• The developed automated procedure provides a reliable and efficient alternative for warfarin sodium determination.
• The method is suitable for quality control testing of warfarin sodium tablets.
• Automation maintains the analytical rigor of the established USP manual procedure.