DEVELOPMENT AND VALIDATION OF A STABILITY-INDICATING RP-HPLC METHOD FOR THE ESTIMATION OF CLOBETASOL PROPIONATE IN BULK AND OINTMENT DOSAGE FORM
A simple, gradient RP- HPLC method has been developed and validated for Clobetasol propionate in bulk and ointment formulation. The successful estimation was carried out of the drug product is developed on C(18) column reversed-phase using Acetonitrile: Methanol: Phosphate buffer (16:20:80 v/v) as mobile phase composition. The flow rate was adjusted to 1.5mL/minute and the absorption maxima were observed at 250 nm utilizing Shimadzu SPD-20A Prominence UV-Vis detector. Clobetasol propionate showed a good and precise linearity in the range 20-100μg/mL. The HPLC, assay shows the purity ranging 99.95 to 102.27% for ointment formulation. The mean percentage purity is 101.11%. The chromatographic retention time of Clobetasol propionate was found to be 5.12 minutes. The statistical analysis shows the method accuracy. Various forced degradation studies was conducted on Clobetasol propionate ointment to examine the stability of the drug. The developed method validated according to the ICH guidelines.
Keywords: Clobetasol propionate, RP-HPLC, UV, validation and forced degradation.
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