Quality Evaluation of Clobetasol Propionate and Betamethasone Valerate Topical Corticosteroid Creams Marketed in Addis Ababa
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Date
2010-04
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Addis Ababa University
Abstract
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.
Description
Keywords
corticosteroids;clobetasol 17-propionate; betamethasone-17-valerate;microbial limit; identification;assay and retention factor