SIMULTANEOUS DETERMINATION OF CLOBETASOL (AS PROPIONATE) AND CHLOROCRESOL IN CREAM BY STABILITY INDICATING RP-HPLC METHOD
Abstract
A stability-indicating reverse phase-HPLC method has been developed and validated for the simultaneous determination of Clobetasol propionate (CLOB) and Chlorocresol (CHLOR) in pharmaceutical dosage form (cream). Beclomethasone dipropionate monohydrate (BEC) was used as internal standard. The column (Luna) C18 (250 mm × 4.6 mm, 5μm particle size) was used for chromatographic separation. The gradient elution system was performed using mobile phase A: Ammonium dihydrogen phosphate pH 4.5 and methanol in the ratio of 80:30 respectively, and Acetonitrile as mobile phase B. The flow rate was adjusted to 1.5 ml/min. The column oven was set at 25°C and the detection wavelength at 240nm. The retention times of CHLOR, CLOB and BEC were found to be 8.86 min, 13.36 min and 15.6 min respectively. The linearity was performed in the concentration ranges of 64.0-96.0μg/ml (CHLOR), 32.0-48.0μg/ml (CLOB), and 80μg/ml (BEC) with squared correlation coefficient of 0.9995 and 0.9996 for CHLOR and CLOB respectively. The percentage purity of CHLOR and CLOB was found to be > 99.5 %. The analytical method has been validated for specificity, linearity, precision, accuracy, ruggedness and robustness which were found to be within the acceptance limit according to ICH guidelines. The developed method was successfully employed for routine and stability analysis of CHLOR and CLOB in pharmaceutical cream.
Keywords:
Chlorocresol, Clobetasol propionate, Beclomethasone dipropionate, Stability-Indicating, RP-HPLC, ValidationDOI
https://doi.org/10.25004/IJPSDR.2014.060212References
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