别嘌醇缓释片的含量测定和有关物质检查

Content Determination of Allopurinol Sustained-release Tablets and Related Substances

目的:建立别嘌醇缓释片的含量测定和有关物质的检查方法。方法:采用高效液相色谱法。色谱柱为Inertsil@ODS-3,流动相为甲醇-0.125%磷酸二氢钾溶液(10:90,V/V),流速为1.0ml/min,有关物质和主药检测波长分别为220、250nm。对别嘌醇杂质A进行定量检查,对其他未知杂质采用自身对照法检查。结果:主药与杂质能完全分离;主药和杂质的检测质量浓度线性范围分别为1～100、0.02～4μg/m(lr均为0.9999),平均回收率分别为100.1%、95.3%,RSD分别为0.7%、14%;杂质A最低检测限为0.2ng。结论:本法具有良好的专属性、灵敏度和重复性,适用于别嘌醇缓释片的质量控制。

OBJECTIVE：To establish a method for the content determination of Allopurinol sustained-release tablets and related substances.METHODS：HPLC method was adopted.The determination was performed on Inertsil@ODS-3 column with mobile phase consisted of methanol-0.125% monopotassium phosphate（10：90,V/V）at the flow rate of 1.0ml/min.The detection wavelength was set at 220nm and 250 nm for related substances and main component.The quantity of allopurinol impurity A was detected quantitatively and other impurities by self control method.RESULTS：Relative substances could be separated from main component completely.The linear ranges of main component and impurity were 1-100 μg/ml and 0.02-4 μg/ml（r=0.999 9）.The average recoveries were 100.1%（RSD=0.7%）and 95.3%（RSD=14%）.The lowest limit of detection for impurity A was 0.2ng.CONCLUSION：The method is specific,sensitive and reproducible,and can be used for quality control of Allopurinol sustained-release tablets.