Abstract
Clobetasol 17-propionate is used most potent topical glucocorticoid clinical effective in treatment of topical dermatitis, vitiligo and psoriasis. A rapid, simple, selective and precise UV- Visible Spectrophotometric method has been developed for the determination of Clobetasol 17-Propionate (CP) in bulk forms and dosage formulations. The spectrophotometric detection was carried out at an absorption maximum of 239 nm using ethanol as solvent. The method was validated for specificity, linearity, accuracy, precision, and robustness. The detector response for the CP was linear over the selected concentration range 2 to 40μg/ml with a correlation coefficient of 0.9999. The accuracy was between 99.1 and 101.4 %. The precision of 4μg/ml sample preparation three times in a day (intraday) was 0.1325%. The Limit of Detection (LOD) and Limit of Quantification (LOQ) are 0.84 and 2.55μg/ml, respectively. The recovery of CP was about 101.84%. The results demonstrated that the excipients in the commercial formulation did not interfere with the method and can be conveniently employed for daily routine quality control analysis of CP in bulk drug, marketed formulations.
Highlights
High potency dihalogenated corticosteroid, Clobetasol 17-Propionate (CP) is used for skin diseases such as vitiligo, psoriasis and atopic dermatitis due to its antiinflammatory, vasoconstrictive, antiproliferative and immunosuppressive activities
Clobetasol 17-Propionate is used to relieve redness, itching, sweeling, or other discomfort caused by skin conditions
Literature search reveals HPLC, RP-HPLC and liquid chromatography methods were reported for determination of various salts of Clobetasol in formulations like ointment, creams and suspensions[6,7,8,9,10,11]
Summary
Clobetasol 17-Propionate (CP) is used for skin diseases such as vitiligo, psoriasis and atopic dermatitis due to its antiinflammatory, vasoconstrictive, antiproliferative and immunosuppressive activities. It was proven to be the first topical corticosteroid that demonstrated satisfactory results in the treatment for psoriasis[2,4]. Literature search reveals HPLC, RP-HPLC and liquid chromatography methods were reported for determination of various salts of Clobetasol in formulations like ointment, creams and suspensions[6,7,8,9,10,11]. Some simultaneous analytical estimations of Clobetasol 17-Propionate with other drugs have been reported in literature[12,13,14,15,16]. No studies have been reported for estimation of CP in bulk and ointment formulation using a validated UV-visible spectrophotometric assay method. The aim of the present work is to develop and validate analytical method by UV-Visible spectrophotometer which is simple, rapid and advantageous and in which no complexation agent, extraction, derivatization, or evaporation steps are involved
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