沈春丽,黄文华,梁洪,宋艳刚
SHEN Chunli,HUANG Wenhua,LIANG Hong,SONG Yangang

• 1:丽珠集团利民制药厂

摘要(Abstract)：

目的建立测定混合糖电解质注射液中5-羟甲基糠醛含量的高效液相色谱(HPLC)法。方法色谱柱:Welch Topsil C18柱(250 mm×4.6 mm,5μm),柱温:35℃,流动相:0.05 mol·L~(-1)磷酸二氢钾-乙腈(90∶10,V/V),流速:0.8 mL·min~(-1),检测波长:284 nm。结果 5-羟甲基糠醛在0.5~5μg·mL~(-1)范围内与峰面积呈良好的线性关系,r=1.000 0;加样回收率在93.3%~96.0%之间,RSD为0.93%;检测的3批混合糖电解质注射液中5-羟甲基糠醛的含量均低于10μg·mL~(-1)。结论该方法简便快速,准确可靠,重现性好,是测定混合糖电解质注射液中5-羟甲基糠醛含量的有效方法。
OBJECTIVE To establish a method for the determination of 5-hydroxymethyl furfural in Carbohydrate and Electrolyte Injection.METHODS The HPLC column was Welch Topsil C_(18)(250 mm×4.6 mm,5 μm) with mobile phases consisting of0.05 mol·L~(-1) KH_2PO_4-acetonitrile(90∶10,V/V) at a flow rate of 0.8 mL·min~(-1).The detection wavelength was 284 nm,and the column temperature was 35 ℃.RESULTS 5-hydroxymethyl furfural in the range of 0.5-5 μg·mL-1 and peak area showed a good linear relationship,r=1.000 0.The recovery rate was between 93.3%-96.0%,and RSD was 0.93%.The content of 5-hydroxymethyl furfural was less than 10 μg·mL~(-1) in three batches of Carbohydrate and Electrolyte Injection.CONCLUSION This method is simple,rapid,accurate,reliable and reproducible.It is an effective method for the determination of 5-hydroxymethyl furfural in Carbohydrate and Electrolyte Injection.

关键词(KeyWords)： 混合糖电解质注射液;5-羟甲基糠醛;高效液相色谱法
carbohydrate and electrolyte injection;5-hydroxymethyl furfural;HPLC

Abstract:

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基金项目(Foundation): 韶关市科技计划项目(2012CX/G04)

作者(Author): 沈春丽,黄文华,梁洪,宋艳刚
SHEN Chunli,HUANG Wenhua,LIANG Hong,SONG Yangang

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