离子色谱法测定甘露醇原料及注射液的含量和有关物质

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。

Determinations of Mannitol and Related Substances in Mannitol and Mannitol Injection by Ion Chromatography

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.