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High-performance liquid chromatographic assay of codeine in acetaminophen with codeine dosage forms
Journal of Pharmaceutical Sciences
|September 1, 1980
Summary
A new high-performance liquid chromatographic (HPLC) assay accurately quantifies codeine in acetaminophen combination products within 10 minutes. This rapid method ensures precise and reliable results for pharmaceutical analysis.
Area of Science:
- Analytical Chemistry
- Pharmaceutical Analysis
Background:
- Acetaminophen with codeine products are widely used for pain relief.
- Accurate quantification of codeine is crucial for product quality and patient safety.
Purpose of the Study:
- To develop and validate a rapid, accurate, and specific high-performance liquid chromatographic (HPLC) assay for codeine.
- To analyze codeine in the presence of acetaminophen and potential impurities.
Main Methods:
- High-Performance Liquid Chromatography (HPLC) was employed.
- Chlorpheniramine maleate served as the internal standard.
- Separation and quantification of codeine, acetaminophen, and impurities were achieved.
Main Results:
- The developed HPLC assay demonstrated excellent separation of all components within 10 minutes.
- High precision and accuracy were observed, with relative standard deviations below 0.5%.
- A strong linear correlation was established between HPLC and Gas-Liquid Chromatography (GLC) methods.
Conclusions:
- The developed HPLC assay is a suitable, rapid, and accurate method for codeine determination in combination products.
- This method can be reliably used for quality control in pharmaceutical manufacturing.
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