Quality Evaluation of Clobetasol Propionate and Betamethasone Valerate Topical Corticosteroid Creams Marketed in Addis Ababa

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Addis Ababa University


Topical corticosteroids have revolutionized the practice of dermatology since their introduction in the late 1950s. They have improved the management of many inflammatory skin diseases but like all medications, the drugs are associated with potential adverse (side) effects. Five brands of cream formulations (GlaxoSmithKline of England and Saudi Arabia), Zygpharma pvt. Ltd (India), Hoe Pharmaceuticals (Malaysia) and Pharma Inkl (Jordan)) containing, 0.05 % w/w clobetasol -17-propionate (CP) and 0.1% w/w betamethasone -17-valerate (BV) as active ingredients were purchased from different retail outlets in Addis Ababa and their qualities were evaluated for microbiological, identification (qualitative) and assay(quantitative) tests using the official USP 2008. Microbial limit test mannital – salt and cetrimide agar media were used to test the presence or absence of Staphylococcus aureus and Pseudomonas aeruginosa, respectively. The specimens were incubated for five days at a temperature of 25 OC but the growth of the expected microorganisms were not observed ( i.e the results were negative ). Identification test was performed using thin layer chromatography; clobetasol propionate (1.0 gm) and betamethasone valerate (2.0 gm) creams were weighed and extracted with a series of steps using appropriate chemicals which are recommended by USP 2008. The dried residues were dissolved in chloroform and equal volumes (10μl) of the standards and the tests were spotted. After the plates were dried in the hood their retention factor (Rf) values were calculated by measuring the distance traveled by the standards and the extracts to that of the solvent front and found to be as 0.56 for clobetasol propionate and 0.33 for betamethasone valerate. x Assay was performed by using RP-HPLC. Clobetasol propionate (2 gm) and betamethasone valerate (2.5 gm) cream were weighed and extracted with methanol. The mixtures were shaken using a shaker and centrifuged at about 3500 rpm for 10 minutes followed by filtration through a 0.45 μm filter paper and the filtrates were added into a vial. Equal volumes of the standard and the sample (10 μl) were injected at a flow rate of 1.0 ml/min for clobetasol propionate and 1.2 ml/min for betamethasone valerate and the amount in mg of each active ingredient were found as 0.908 to 1.149 mg (90.8-114.9%) clobetasol propionate and 2.41 to 2.76 mg (96.4-110.4 %) betamethasone valerate. The above results showed that all the brands of the two cream products fulfill the USP 2008 specifications interms of physical stability (appearance), microbiological, identification and assay tests. Key words: corticosteroids, clobetasol 17-propionate, betamethasone-17-valerate, microbial limit, identification, assay and retention factor.



corticosteroids;clobetasol 17-propionate; betamethasone-17-valerate;microbial limit; identification;assay and retention factor