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Liquid chromatographic determination of acetaminophen in tablets: collaborative study
Journal - Association of Official Analytical Chemists
|March 1, 1987
Summary
A validated reverse phase liquid chromatography method accurately determines acetaminophen in various tablet formulations. This robust analytical method achieved excellent repeatability and reproducibility across multiple laboratories.
Area of Science:
- Analytical Chemistry
- Pharmaceutical Analysis
Background:
- Accurate quantification of acetaminophen is crucial for pharmaceutical quality control.
- Existing methods require validation for diverse tablet compositions.
Purpose of the Study:
- To collaboratively study and validate a reverse phase liquid chromatographic method for acetaminophen determination in tablets.
- To assess the method's performance across different commercial and synthetic formulations.
Main Methods:
- Collaborative study involving 5 laboratories analyzing synthetic and commercial acetaminophen tablet samples.
- Application of a previously reported reverse phase liquid chromatography (RPLC) method.
- Statistical analysis of pooled repeatability (CVDo) and reproducibility (CVDx) values.
Main Results:
- Excellent pooled repeatability (CVDo) and reproducibility (CVDx) values were observed for proprietary (0.89%, 1.34%) and generic (0.66%, 0.74%) tablets.
- High recovery (98.9%) of acetaminophen from synthetic formulations with low variability.
- Overall method repeatability was 0.64% and reproducibility was 0.95%.
Conclusions:
- The reverse phase liquid chromatographic method is highly reliable and reproducible for acetaminophen quantification in tablets.
- The method's adoption as official first action underscores its validated performance and suitability for pharmaceutical quality control.