摘要
目的：建立同时测定甘露醇原料、甘露醇注射液含量及有关物质的离子色谱方法。方法：采用Carbopac MA1 Analytical （4 mm ×250 mm）及Carbopac MA1 Guard（4 mm ×50 mm）色谱柱，淋洗液为0.6 mol· L^-1氢氧化钠溶液，流量0.4 mL· min^-1，检测器为安培检测器，采用金电极、Ag/AgCl参比模式、IPAD，糖四电位波形。结果：甘露醇峰面积在0.1～20μg· mL^-1范围内与其浓度成良好线性关系（A＝5.7502C-0.251，R^2＝1），平均回收率为99.7％（n＝9），最低检测限为0.03μg· mL^-1，最低定量限为0.1μg· mL^-1。结论：本方法准确，专属性强，灵敏度高，可用于甘露醇及甘露醇注射液的质量控制。
Objective：To establish an ion chromatography method for the determinations of mannitol and its related substances in mannitol and mannitol injection.Methods：The columns were Carbopac MA1 Analytical（4 mm ×250 mm） and Carbopac MA1 Guard （4 mm ×50 mm） , eluent was 0.6 mol· L^-1 NaOH with flow rate of 0.4 mL· min^-1 , using amperometric detector with a gold electrode , Ag/AgCl reference model , IPAD, sugar four potential waveform.Results：The linear range of mannitol was 0.1-20 μg· mL^-1 （ A=5.7502C-0.251, R^2 =1）, the mean recovery was 99.7%（n=9）, the lowest detection limit was 0.03 μg· mL^-1, and the lower limit of quantification was 0.1 μg· mL^-1.Conclusion：The method is sensitive, accurate and rapid.It is suitable for the quality control of mannitol and mannitol injection.
出处
《中国药品标准》
CAS
2014年第3期194-195,205,共3页
Drug Standards of China
关键词
甘露醇
甘露醇注射液
离子色谱
含量测定
有关物质
mannitol
mannitol injection
ion chromatography
content determination
related substances
