月桂氮酮中有关物质测定方法的改进  

Improved determination method for the related substances in Laurocapram

作　　者：刘峰[1,2] 别小琳 袁军 

机构地区：[1]四川大学生物治疗国家重点实验室,四川成都610041 [2]四川省食品药品检验检测院,四川成都610097

出　　处：《华西药学杂志》2016年第6期653-655,共3页West China Journal of Pharmaceutical Sciences

摘　　要：目的 改进月桂氮酮中有关物质的测定方法。方法 采用气相色谱法,以甲醇为溶剂、Agilent DB-1毛细管柱（30m×0.53 mm,3.0μm）、程序升温、氢火焰离子化检测器进行测定。结果 所用色谱条件可使月桂氮酮及其强降解杂质得到有效分离,专属性、重复性良好;杂质己内酰胺的检出限为0.13μg·m L^-1,线性方程为：Y=2.3511×10^3X-0.2742,10.78～269.5μg·m L^-1己内酰胺与峰面积的线性关系良好（r=0.9984）。结论 改进后的方法操作简便,准确可靠,可有效地检测月桂氮酮中的有关物质。OBJECTIVE To improve the method for the determination of related substances in Lauroeapram. METHODS The related substances were determined by gas chromatography using ethano as dissolvent. FID detector and Agilent DB - 1 （ 30 m × 0.53 mm, 3.0 μm）were used and the column temperature was programmed raised. RESULTS Lanrocapram and its related substances were separated effectively by the developed method which was specific and repeatable. The LOD of impurity caprolactam was 0. 13 μg·m L^-1. The linear range of caprolactam was 10.78 -269.5 mg·-mL^-1. The regression equation was Y = 2.3511× 10^3X -0. 2742 （r = 0. 9984 ）. CONCLUSION The method is simple, specific and reliable for the determination of the related substances in Lauroeapram.

关 键 词：月桂氮酮 己内酰胺 有关物质 改进 气相色谱法 含量测定 

分 类 号：R917[医药卫生—药物分析学]