Redox methods validation of paracetamol and ascorbic acid in pharmaceutical preparations

Area of Science:

• Pharmaceutical Chemistry
• Analytical Chemistry

Background:

• Combination drug products require precise quantification of active pharmaceutical ingredients (APIs).
• Ensuring API content meets pharmacopeial standards is crucial for drug safety and efficacy.

Purpose of the Study:

• To develop and validate analytical methods for determining paracetamol and ascorbic acid content in a multi-ingredient preparation (TP-4).
• To assess the compliance of TP-4 and other commercial products with pharmacopeial specifications for these APIs.

Main Methods:

• Development of non-specific redox-based methods for paracetamol (cerometric titration) and ascorbic acid (2,6-dichloroindophenol titration).
• Method validation using model mixtures to assess accuracy, precision, reproducibility, and linearity across a 50-150% range.
• Application of validated methods to analyze TP-4 and other listed pharmaceutical preparations.

Main Results:

• Validated methods demonstrated accuracy, precision, reproducibility, and linearity for paracetamol and ascorbic acid determination.
• Analysis confirmed that the content of paracetamol and ascorbic acid in TP-4 and other tested products adhered to the Polish Pharmacopoeia V (FP V) requirements (+/- 10% of declared amount).

Conclusions:

• The developed cerometric and titration methods are suitable for accurate and reliable quantification of paracetamol and ascorbic acid in pharmaceutical preparations.
• The tested products, including TP-4, comply with established pharmacopeial standards for the analyzed active substances.