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Stability of cefuroxime axetil in suspensions
Y Pramar1, V Das Gupta, C Bethea
1Department of Pharmaceutics, University of Houston, TX 77030.
Journal of Clinical Pharmacy and Therapeutics
|October 1, 1991
Summary
A new HPLC method accurately quantifies cefuroxime axetil. Sugar-containing suspensions showed excellent stability for cefuroxime axetil up to 28 days at 5°C, unlike sugar-free formulations.
Area of Science:
- Pharmaceutical Sciences
- Analytical Chemistry
Background:
- Cefuroxime axetil is an antibiotic present as a 50:50 mixture of two active isomers.
- Assessing the stability of cefuroxime axetil in various suspension formulations is crucial for ensuring therapeutic efficacy.
Purpose of the Study:
- To develop and validate a stability-indicating high-pressure liquid chromatography (HPLC) method for cefuroxime axetil quantification.
- To evaluate the chemical stability of cefuroxime axetil in different suspension vehicles.
Main Methods:
- Development of a stability-indicating HPLC method for cefuroxime axetil.
- Quantification of cefuroxime axetil in suspensions stored at 5°C over 28 days.
- Assessment of pH and physical appearance of the suspensions.
Main Results:
- The developed HPLC method demonstrated high accuracy, precision (RSD 1.2%), and reproducibility.
- Cefuroxime axetil suspensions in sugar-containing vehicles showed minimal degradation (±6%), while sugar-free vehicles exhibited significant variability (±31%).
- Cefuroxime axetil remained stable for 28 days at 5°C in sugar-containing suspensions, with stable pH and physical appearance.
Conclusions:
- The validated HPLC method is suitable for stability studies of cefuroxime axetil.
- Viscous, sugar-containing vehicles enhance the chemical stability of cefuroxime axetil suspensions.
- Refrigerated storage at 5°C for 28 days maintains cefuroxime axetil stability in optimized suspension formulations.