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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 (r(2) = 0.9999). The relative standard deviation values for intra- and inter-day precision studies were &lt; 1% and the recovery of hydroxybenzene was &gt;99%. The limit of detection and quantitation for hydroxybenzene was found to be 13.5 η g/ml and 2 μg/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.

Development and validation of a reversed-phase HPLC method for the determination of hydroxybenzene in a cream formulation