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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。
Objective To study the determination of crotamiton. Methods The content of crotamiton reference substance was determined by mass balance method, high performance liquid chromatography external standard method and nuclear magnetic quantification (QNMR). The accuracy of the results of the three methods was evaluated. Results The contents of the above three methods were 99.2%, 102.9% and 99.1%, respectively. Conclusion Due to the different UV-response factors of cis- and trans-isomers of this product, the method of calculating the content of the sum of cis- and trans-isomers peak area in the current edition of Chinese Pharmacopoeia 2010 edition is questionable. The QNMR rule The content of cis-trans isomers can be measured separately, which provides a corroborative method for the determination of standard materials.