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Determination of fluoride in fluoride tablets and solutions by ion-selective electrode: collaborative study
Summary
A new fluoride ion-selective electrode method accurately determines fluoride in tablets and solutions. This validated method shows high recovery and low variation, achieving official adoption.
Area of Science:
- Analytical Chemistry
- Electrochemistry
Background:
- Accurate determination of fluoride concentration is crucial for pharmaceutical quality control.
- Existing methods may lack precision or require complex procedures.
Purpose of the Study:
- To develop and validate a novel method for quantifying fluoride (F) ion concentration.
- To assess the method's reliability in pharmaceutical formulations like tablets and solutions.
Main Methods:
- Utilized a fluoride ion-selective electrode for potentiometric determination.
- Conducted a collaborative study involving 11 laboratories and 8 diverse sample types.
- Analyzed authentic and commercial fluoride solutions and tablets.
Main Results:
- Achieved high average recoveries (99.5-99.6%) for authentic fluoride solutions.
- Demonstrated low relative coefficients of variation (CV) across all sample types (1.88-3.71%).
- Commercial samples showed results close to declared values, with mean values ranging from 0.981 to 0.994 mg.
Conclusions:
- The developed fluoride ion-selective electrode method is precise and accurate for determining fluoride in pharmaceutical products.
- The method's successful collaborative study led to its adoption as an official first action method.