Asian Journal of Chemistry and Pharmaceutical Sciences

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Development and Validation of UV Spectrophotometric Method for Quantitative Estimation of Clobetasol 17-Propionate


Affiliations
  • Guru Jambheshwar University of Science and Technology, Department of Pharmaceutical Sciences, Hisar, India
  • Guru Jambheshwar University of Science and Technology, Department of Pharmaceutical Sciences, hisar, India
  • Maharishi Dayanand University, Department of Pharmaceutical Sciences, Rohtak, India
 

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.

Keywords

Clobetasol 17-Propionate, ICH Guidelines, UV-Visible Spectroscopy, Validation
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  • Development and Validation of UV Spectrophotometric Method for Quantitative Estimation of Clobetasol 17-Propionate

Abstract Views: 813  |  PDF Views: 248

Authors

Neelam Devi
, India
Sunil Kumar
, India
Sunny Rajan
, India
Jagbir Gegoria
, India
Sheefali Mahant
, India
Rekha Rao
, India

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.

Keywords


Clobetasol 17-Propionate, ICH Guidelines, UV-Visible Spectroscopy, Validation

References