Determination of Sodium Fusidate and Fusidic Acid In Dosage Forms by High-Performance Liquid Chromatography and a Microbiological Method

A new High-performance liquid chromatographic (HPLC) method for the assay of sodium fusidate (I) or fusidic acid in dosage forms was developed and compared to a microbiological assay. A linear relationship was obtained between absolute peak area and amount of I (r = 0.99+) in the 50-1000-μg/ml range...

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Bibliographic Details
Published in:Journal of pharmaceutical sciences 1982-11, Vol.71 (11), p.1297-1298
Main Authors: Hikalx, Ahmed H., Shibl, Atef, El-Hoofy, Sammy
Format: Article
Language:English
Subjects:
Biological Assay
Chromatography, High Pressure Liquid - methods
Fusidate sodium-determination in dosage forms
Fusidate sodium—determination in dosage forms high-performance liquid chromatography, microbiological method, tablets, suspension, ointment
Fusidic Acid - analysis
Fusidic acid-determination in dosage forms
Fusidic acid—determination in dosage forms sodium fusidate, high-performance liquid chromatography, microbiological method, tablets, suspension, ointment
high-performance liquid chromatography
High-performance liquid chromatography-determination of fusidate sodium and fusidic acid in dosage forms
High-performance liquid chromatography—determination of fusidate sodium and fusidic acid in dosage forms microbiological method, tablets, suspension, ointment
Keyphrases
microbiological method
ointment
Ointments - analysis
sodium fusidate
suspension
Suspensions - analysis
tablets
Tablets - analysis
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Summary:A new High-performance liquid chromatographic (HPLC) method for the assay of sodium fusidate (I) or fusidic acid in dosage forms was developed and compared to a microbiological assay. A linear relationship was obtained between absolute peak area and amount of I (r = 0.99+) in the 50-1000-μg/ml range. In the microbiological assay, Staphylococcus aureus (NCTC 6571) was the test organism, using an agar diffusion technique. With five test levels of the standard, potencies were interpolated from standard curve using a log transformation straight-line method with least-squares fitting (r = 0.99+). Both methods were applied to assay I (or fusidic acid) in tablets, a suspension, and an ointment. Excellent agreement was observed between results of the two methods.
ISSN:0022-3549
1520-6017
DOI:10.1002/jps.2600711130