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Analysis of fludrocortisone acetate and its solid dosage forms by high-performance liquid chromatography
A new high-performance liquid chromatography method accurately measures fludrocortisone acetate content uniformity. This stability-indicating assay effectively separates impurities and degradation products.
Area of Science:
- Analytical Chemistry
- Pharmaceutical Analysis
Background:
- Fludrocortisone acetate is a crucial corticosteroid medication.
- Accurate content uniformity testing is essential for pharmaceutical quality control.
Purpose of the Study:
- To develop and validate a novel reversed-phase high-performance liquid chromatographic (HPLC) assay for fludrocortisone acetate.
- To establish a stability-indicating method for determining content uniformity and detecting impurities.
Main Methods:
- Development of a reversed-phase HPLC method.
- Validation of the assay for accuracy, sensitivity, and interference.
- Assessment of the method's stability-indicating capabilities.
Main Results:
- The developed HPLC method is simple, sensitive, and accurate.
- The assay effectively separates known degradation products and impurities.
- The coefficient of variation for multiple weight assays ranged from 0.3% to 1.8%.
Conclusions:
- The new HPLC method is suitable for determining fludrocortisone acetate content uniformity.
- The method's stability-indicating nature ensures reliable quality control.
- This assay provides a robust tool for pharmaceutical analysis of fludrocortisone acetate.
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