Development and Validation of a Reversed-phase HPLC Method for the Determination of Hydroxybenzene in a Cream Formulation

摘要

A rapid, sensitive and specific reversed-phase high performance liquid chromatographic method with diode-array detection has been developed and validated for the determination of hydroxybenzene (0.494%, w/w) in a commercially available cream pharmaceutical formulation. Isocratic chromatography was performed on a C18 column with methanol-water 60:40 (v/v) containing 0.1% phosphoric acid (v/v) as mobile phase at a flow rate of 1.0 ml/min. UV detection was at 254 nm. Linearity of the method was excellent (r2 = 0.9999). The relative standard deviation values for intra- and inter-day precision studies were < 1% and the recovery of hydroxybenzene was >99%. The limit of detection and quantitation for hydroxybenzene was found to be 13.5 g/ml and 2 ug/ml, respectively. The method was also validated for specificity and robustness. The method was found to be robust and can be reliably used to determine the hydroxybenzene content of marketed formulations.