Quantitative determination of clobetasone butyrate in bulk and cream formulation by a validated stability-indicating reversed-phase HPLC method
Hassan Ahmad Alhazmi (1,*) , Gunasekar Manoharan (2) , Mohammed Al Bratty (3) , Sadique Akhtar Javed (4)
(1) Department of Pharmaceutical Chemistry, College of Pharmacy, Jazan University, Jazan, 45142, Kingdom of Saudi Arabia
(2) Chemistry Department, Faculty of Science, Jazan University, Jazan, 45142, Kingdom of Saudi Arabia
(3) Department of Pharmaceutical Chemistry, College of Pharmacy, Jazan University, Jazan, 45142, Kingdom of Saudi Arabia
(4) Department of Pharmaceutical Chemistry, College of Pharmacy, Jazan University, Jazan, 45142, Kingdom of Saudi Arabia
(*) Corresponding Author
Received: 08 Mar 2018, Accepted: 18 Apr 2018, Published: 30 Jun 2018
A simple isocratic reversed-phase HPLC method for quantification of clobetasone in bulk and cream dosage forms has been developed. Chromatographic analysis was accomplished on an C18 column utilizing a mixture of methanol and water (84:16 v:v, pH = 6.0) as mobile phase. An effluent flow rate of 1 mL/min was adjusted and the detection was made at 240 nm wavelength. The method was evaluated according to ICH guidelines Q2 R1 for linearity, specificity, sensitivity, precision and accuracy. The method exhibited good linearity with correlation coefficient (r2) of 0.9993 over the concentration range from 5 to 50 μg/mL. The recoveries of the test drug from the cream sample was found to be 98.56 to 99.51% and the limit of detection and quantification were calculated as 0.85 and 2.83 μg/mL, respectively, suggesting the accuracy and sensitivity of the developed method. The precision was demonstrated by a low percentage of relative standard deviation (<1%) from six independent assay analysis performed for the cream formulation. Stability indicating property of the proposed method was demonstrated by performing the analysis of forced degradation samples. The developed method can be used for estimation of the clobetasone butyrate in bulk and pharmaceutical formulations for routine analysis in the quality control laboratories.
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DOI Link: https://doi.org/10.5155/eurjchem.9.2.92-98.1700
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