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别嘌醇缓释片的含量测定和有关物质检查 被引量:1

Content Determination of Allopurinol Sustained-release Tablets and Related Substances
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摘要 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.
作者 陈红 朱蓉
出处 《中国药房》 CAS CSCD 2013年第1期80-82,共3页 China Pharmacy
关键词 别嘌醇缓释片 含量测定 有关物质 杂质A 高效液相色谱法 Allopurinol sustained-release tablets Content determination Related substance Impurity A HPLC
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