HPLC法测定氧化樟脑注射液的有关物质  

HPLC determination of related substances of vitacamphorae injection

作　　者：刘艳娥[1] 车慧[1] 靳守东[1] 梁爱君[1] 

机构地区：[1]总后勤部卫生部药品仪器检验所,北京100166

出　　处：《药物分析杂志》2012年第5期861-864,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立高效液相色谱法测定氧化樟脑注射液的有关物质,并测定2个杂质的校正因子。方法:采用Kromasil 100-5C18(250 mm×4.6 mm,5"m)色谱柱,流动相为95%乙腈溶液(A)-0.2%磷酸溶液(B),线性梯度洗脱[0 min,20%A;0～20min,20%A→80%A,保持15 min],流速1 mL·min-1,检测波长286 nm。结果:样品中氧化樟脑峰与杂质峰分离良好;初步鉴定了2个主要杂质的结构,采用加校正因子的主成分自身对照法控制其质量。结论:所建立的方法简便、快速,可准确地测定氧化樟脑注射液中的有关物质。Objective： To establish an HPLC method for the determination of the related substances of vitacamphorae injection and calculate the correction factor of the impurities.Methods： The chromatographic column was Kromasil 100-5 C18（250 mm×4.6 mm,5 μm）,the mobile phase consisted of 95% acetonitrile（A）-0.2% phosphoric acid（B） with linear gradient elution[0 min,20%A;0-20 min,20%A→80%A,keeping 15 min],the flow rate was 1 mL·min-1,and the detection wavelength was 286 nm.Results： Vitacamphorae peak was separated with other impurity peaks thoroughly;Structure of two main impurities was identified;Corrected peak areas of impurities compared with that produced by the main peak of a diluted solution of substance being examined.Conclusion： The method is simple,rapid,specific,accurate and suitable for analysing the related substances in vitacamphorae injection.

关 键 词：高效液相色谱法 校正因子 自身对照法 氧化樟脑 中枢兴奋药 注射剂 有关物质 杂质 安全监测 

分 类 号：R917[医药卫生—药物分析学]