Shabir G A
Oxford Brookes University, School of Life Sciences, Headington Campus, Oxford, OX3 0BP, United Kingdom.
Indian J Pharm Sci. 2010 May;72(3):307-11. doi: 10.4103/0250-474X.70475.
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 < 1% and the recovery of hydroxybenzene was >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.
已开发并验证了一种采用二极管阵列检测的快速、灵敏且特异的反相高效液相色谱法，用于测定市售乳膏剂药物制剂中羟基苯（0.494%，w/w）的含量。在C18柱上进行等度色谱分析，以甲醇 - 水60:40（v/v）含0.1%磷酸（v/v）作为流动相，流速为1.0 ml/min。紫外检测波长为254 nm。该方法的线性良好（r(2) = 0.9999）。日内和日间精密度研究的相对标准偏差值均<1%，羟基苯的回收率>99%。羟基苯的检测限和定量限分别为13.5 ηg/ml和2 μg/ml。该方法还进行了特异性和稳健性验证。结果表明该方法稳健，可可靠地用于测定市售制剂中羟基苯的含量。
