Simple spectrophotometric methods for the quantitative analysis of two binary mixtures containing paracetamol as a...

Area of Science:

• Analytical Chemistry
• Pharmaceutical Analysis
• Spectrophotometry

Background:

• Simultaneous determination of multiple active pharmaceutical ingredients in a single dosage form presents analytical challenges.
• Accurate quantification is crucial for ensuring drug efficacy and patient safety.
• Development of simple, reliable, and cost-effective analytical methods is essential for quality control.

Purpose of the Study:

• To develop and validate simple, reliable spectrophotometric methods for the simultaneous determination of paracetamol (PAR) and meloxicam (MEL) in mixture I.
• To develop and validate simple, reliable spectrophotometric methods for the simultaneous determination of paracetamol (PAR) and domperidone (DOM) in mixture II.
• To assess the greenness of the developed analytical procedures.

Main Methods:

• Direct zero-order spectrophotometry and first-order derivative (1D) spectrophotometry were employed for the PAR-MEL mixture.
• A ratio difference method was utilized for the simultaneous determination of PAR and DOM.
• Method validation was performed according to ICH criteria, including linearity, range, precision, accuracy, and limits of detection and quantitation.

Main Results:

• The developed methods demonstrated excellent linearity with correlation coefficients of at least 0.9991 for mixture I and 0.9999 for mixture II across specified concentration ranges.
• The methods were successfully applied to laboratory-made tablets, yielding assay results comparable to reported methods.
• The analytical procedures were evaluated for their environmental impact using the Analytical Eco-Scale and AGREE metric.

Conclusions:

• Simple and reliable spectrophotometric methods (zero-order, 1D derivative, and ratio difference) are effective for the simultaneous quantification of PAR with MEL and DOM.
• The validated methods are suitable for the analysis of these drug combinations in bulk and pharmaceutical formulations.
• The developed spectrophotometric procedures exhibit favorable green analytical characteristics.