Rapid fluorometric determination of procainamide hydrochloride dosage forms

Area of Science:

• Analytical Chemistry
• Pharmaceutical Analysis

Background:

• The analysis of procainamide hydrochloride is crucial for therapeutic drug monitoring and quality control.
• Existing analytical methods may lack the desired sensitivity, speed, or ease of use.

Purpose of the Study:

• To develop and validate a novel, sensitive, and rapid fluorometric assay for procainamide hydrochloride.
• To provide an improved analytical method for procainamide hydrochloride quantification.

Main Methods:

• A fluorometric procedure utilizing the reaction of procainamide hydrochloride with fluorescamine in an aqueous medium at pH 7.5.
• Spectrofluorometric measurement of the resulting fluorophore at activation and emission wavelengths of 400 nm and 485 nm, respectively.

Main Results:

• The developed method demonstrated excellent linearity (r = 0.999) over a concentration range of 0.04–1 µg/ml.
• The fluorescence signal was stable for at least 2 hours.
• High accuracy and reproducibility were confirmed with an overall recovery of 99.8% ± 1.14% (n=5).
• The method was successfully applied to analyze procainamide hydrochloride in commercial dosage forms.

Conclusions:

• The novel fluorometric method provides a significant improvement in ease, speed, and sensitivity for procainamide hydrochloride determination compared to the official method.
• This validated assay is suitable for the accurate and reliable quantification of procainamide hydrochloride in pharmaceutical products.