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Ion exchange method for determining mephentermine sulfate in drug formulations: collaborative study
Journal - Association of Official Analytical Chemists
|January 1, 1978
Summary
This study details a method for analyzing mephentermine sulfate in drug products using ion exchange chromatography and ultraviolet spectrophotometry. The validated method demonstrated high accuracy and precision in commercial samples and collaborative testing.
Area of Science:
- Analytical Chemistry
- Pharmaceutical Analysis
Background:
- Accurate quantification of active pharmaceutical ingredients is crucial for drug quality control.
- Mephentermine sulfate is a sympathomimetic amine used in various pharmaceutical formulations.
Purpose of the Study:
- To develop and validate an ion exchange chromatography method for separating and quantifying mephentermine sulfate.
- To assess the accuracy and precision of the method in commercial drug formulations.
Main Methods:
- Separation of mephentermine sulfate using ion exchange chromatography.
- Quantification of the separated drug by ultraviolet spectrophotometry.
- Assay of commercial tablets and injectables, followed by a collaborative study with multiple formulations.
Main Results:
- Assays on commercial samples showed recoveries between 97.6% and 104% of declared content.
- A collaborative study yielded mean recoveries from 94.7% to 99.3% across different formulations.
- Coefficients of variation in the collaborative study ranged from 1.39% to 2.00%, indicating high precision.
Conclusions:
- The developed ion exchange chromatography method is suitable for the accurate and precise determination of mephentermine sulfate in pharmaceutical products.
- The method's reliability was confirmed through assays of commercial samples and a collaborative study.