摘要
目的比较并讨论《美国药典》35版、《欧洲药典》8.0版、《英国药典》2013年版和文献中左乙拉西坦有关物质的检测方法,为左乙拉西坦中有关物质检测方法的选择提供依据。方法采用3种方法分析左乙拉西坦的已知杂质、强制降解样品、左乙拉西坦及其注射液,比较各方法的专属性、灵敏度。结果采用《美国药典》的方法检出5个已知杂质,未知杂质数目较多,专属性良好;采用《欧洲药典》的方法检出2个已知杂质,未知杂质数目少;采用文献方法检出5个已知杂质,未知杂质数目较少,杂质间分离度不好。6批样品中,采用《美国药典》方法和《欧洲药典》方法检出的总杂质量相近,文献方法中检出的总杂质量略少。结论《美国药典》的方法最适宜左乙拉西坦中有关物质的检查。
OBJECTIVE To optimize the method for the determination of the related substances of Levetiracetam（Lev） after compa- ring different HPLC methods in the United States Pharmacopeia 36th（USP） ,the European Pharmacopoeia 8.0th （EP） and the British Pharmacopoeia 2013 （BP）and the literature. METHODS Three methods was used to analyze known impurities in Lev, forced degra- dation samples, Lev and their respective injection solutions. And the specificity and sensitivity of each method were compared. RESULTS The method of USP showed the highest sensitivity, the best specificity, and five impurities were detected by this method with a relatively high number of unknown impurities. The EP method could only detect two known impurities with a relatively low num- ber of unknown impurities. The literature method detected 5 known impurities, and had bad separation. The total amount of impurities detected by the USP method and the EP method were similar in six batches of samples, and the literature method detected slightly less. CONCLUSION The USP method can be used for the determination of the related substances in levetiracetam.
出处
《华西药学杂志》
CAS
CSCD
2015年第1期97-100,共4页
West China Journal of Pharmaceutical Sciences
