HPLC法测定氯苯扎利二钠片中有关物质含量

Content Determination of Related Substances in Lobenzarit Disodium Tablets by HPLC

目的:建立测定氯苯扎利二钠片中有关物质含量的方法。方法:采用高效液相色谱法测定3批样品中杂质A(邻氨基苯甲酸)和杂质B(2,4-二氯苯甲酸)及其他有关物质的检查。色谱柱为TianHe C18,流动相为乙腈-磷酸二氢钾溶液(pH3.2)(50:50),流速为1.0ml/min,检测波长为222nm,柱温为30℃。结果:氯苯扎利二钠检测质量浓度线性范围为0.2608～2.608μg/m(lr=0.9994),平均回收率为99.85%,RSD=0.22%(n=9)。氯苯扎利二钠、杂质A、杂质B的检测限分别为0.20224、0.3744、0.8384ng。结论:本法灵敏、准确,可作为氯苯扎利二钠片有关物质的测定方法。

OBJECTIVE：To establish the method for the determination of related substances of Lobenzarit disodium tablets.METHODS：HPLC method was adopted to determin impurity A（anthranilate）,impurity B（2,4-dichlorobenzoic acid）and other related substances of 3 batches of samples.The determination was performed on TianHe C18 column with mobile phase consisted of acetonitrile-monopotassium phosphate（pH 3.2）（50：50）at the flow rate of 1.0 ml/min.The detection wavelength was set at 222 nm and column temperature was 30 ℃.RESULTS：The linear range of lobenzarit disodium were 0.260 8-2.608 μg/ml（r=0.999 4）with average recovery of 99.85%（RSD=0.22%,n=9）.The detection limits of lobenzarit disodium,impurity A and impurity B were 0.202 24 ng,0.374 4 ng and 0.838 4 ng.CONCLUSIONS：The method is sensitive and accurate,and it is suitable for the determination of related substances in Lobenzarit disodium tablets.