Quality Evaluation Of Clobetasol Propionate And Betamethasone Valerate Topical Corticosteroid Creams Marketed In Addis Ababa

Topical corticosteroids have revolutionized the practice of dermatology since theirrnintroduction in the late 1950s. They have improved the management of manyrninflammatory skin diseases but like all medications, the drugs are associated withrnpotential adverse (side) effects.rnFive brands of cream formulations (GlaxoSmithKline of England and Saudi Arabia),rnZygpharma pvt. Ltd (India), Hoe Pharmaceuticals (Malaysia) and Pharma Inklrn(Jordan)) containing, 0.05 % w/w clobetasol -17-propionate (CP) and 0.1% w/wrnbetamethasone -17-valerate (BV) as active ingredients were purchased fromrndifferent retail outlets in Addis Ababa and their qualities were evaluated forrnmicrobiological, identification (qualitative) and assay(quantitative) tests using thernofficial USP 2008.rnMicrobial limit test mannital – salt and cetrimide agar media were used to test thernpresence or absence of Staphylococcus aureus and Pseudomonas aeruginosa,rnrespectively. The specimens were incubated for five days at a temperature of 25rnOC but the growth of the expected microorganisms were not observed ( i.e thernresults were negative ).rnIdentification test was performed using thin layer chromatography; clobetasolrnpropionate (1.0 gm) and betamethasone valerate (2.0 gm) creams were weighedrnand extracted with a series of steps using appropriate chemicals which arernrecommended by USP 2008. The dried residues were dissolved in chloroform andrnequal volumes (10μl) of the standards and the tests were spotted. After the platesrnwere dried in the hood their retention factor (Rf) values were calculated byrnmeasuring the distance traveled by the standards and the extracts to that of thernsolvent front and found to be as 0.56 for clobetasol propionate and 0.33 forrnbetamethasone valerate.rnxrnAssay was performed by using RP-HPLC. Clobetasol propionate (2 gm) andrnbetamethasone valerate (2.5 gm) cream were weighed and extracted withrnmethanol. The mixtures were shaken using a shaker and centrifuged at about 3500rnrpm for 10 minutes followed by filtration through a 0.45 μm filter paper and thernfiltrates were added into a vial. Equal volumes of the standard and the sample (10rnμl) were injected at a flow rate of 1.0 ml/min for clobetasol propionate and 1.2rnml/min for betamethasone valerate and the amount in mg of each active ingredientrnwere found as 0.908 to 1.149 mg (90.8-114.9%) clobetasol propionate and 2.41 torn2.76 mg (96.4-110.4 %) betamethasone valerate.rnThe above results showed that all the brands of the two cream products fulfill thernUSP 2008 specifications interms of physical stability (appearance), microbiological,rnidentification and assay tests.rnKey words: corticosteroids, clobetasol 17-propionate, betamethasone-17-valerate,rnmicrobial limit, identification, assay and retention factor.

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