Development and validation of a dissolution method for warfarin sodium and aspirin combination tablets

Area of Science:

• Pharmaceutical Sciences
• Analytical Chemistry
• Drug Development

Background:

• Warfarin sodium and aspirin are commonly prescribed together.
• Accurate quantification of these drugs in combination formulations is crucial for patient safety and therapeutic efficacy.
• Existing analytical methods may require optimization for simultaneous determination in complex dosage forms.

Purpose of the Study:

• To develop and validate a dissolution method for warfarin sodium-aspirin combination tablets.
• To establish a reliable analytical technique for the simultaneous determination of warfarin sodium, aspirin, and salicylic acid.

Main Methods:

• Dissolution testing using USP Apparatus 1 (baskets) at 50 rpm in phosphate buffer (pH 6.8).
• Reversed-phase liquid chromatography (RP-LC) on an octadecylsilica column with a specific mobile phase composition.
• UV detection at 282 nm for simultaneous drug analysis.

Main Results:

• A robust dissolution method for warfarin sodium-aspirin combination tablets was successfully developed.
• The RP-LC method demonstrated simultaneous determination of warfarin sodium, aspirin, and salicylic acid.
• Validation data confirmed the accuracy, precision, linearity, and ruggedness of the dissolution methodology.

Conclusions:

• The developed dissolution method is suitable for quality control of warfarin sodium-aspirin combination tablets.
• The validated analytical methods provide reliable quantification for these active pharmaceutical ingredients.
• This work contributes to ensuring the quality and consistency of combined drug products.