目的 对克罗米通含量测定方法进行研究。方法 分别采用质量平衡法,高效液相色谱外标法与核磁定量法(QNMR)测定了克罗米通标准物质的含量。并对3个方法结果的准确性进行了评价。结果 采用上述 3种方法测得的含量分别为99.2%、102.9%和99.1%。结论 因本品顺反异构体紫外响应因子可能不同,《中国药典》2010年版克罗米通现行标准中所采用顺反异构体峰面积总和计算含量的方法是值得商榷的;采用QNMR法则可以分别测得顺反异构体的含量,为标准物质的定值提供了佐证的方法。
Abstract
OBJECTIVE To study the content determination method of crotamiton. METHODS The quantitative mass balance method, HPLC external standard method and nuclear magnetic resonance(QNMR) were used to determine the content of crotamiton, respectively. The accuracy of the three methods was evaluated. RESULTS The contents of crotamiton were 99.2%,102.9% and 99.1% respectively as determined by the three different methods. CONCLUSION Because the ultraviolet absorption coefficients of cis- and trans-crotamiton might be different, the current pharmacopoeia method, ie, using integrated peak areas to calculate the content, is questionable. QNMR method can measure the contents of cis- and trans-crotamiton respectively, so it can be a complementary method to establish the reference standard.
关键词
克罗米通 /
含量测定 /
核磁定量法 /
高效液相色谱法
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Key words
crotamiton /
content determination /
quantitative nuclear magnetic resonance /
HPLC
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中图分类号：
R917
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参考文献
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