中文摘要：

建立HPLC法测定5-氨基酮戊酸（5-ALA）盐酸盐粗品中的杂质百分含量.使用带有DAD检测器的安捷伦高效液相色谱仪进行检测,色谱柱为岛津Inertsil ODS-SP色谱柱（4.6 mm×250mm,5μm）;流动相为离子对溶液（辛烷磺酸钠2.16 g、磷酸二氢钠3.12 g,加水配成1 000 m L溶液,磷酸调节p H值为3.65）-乙腈（82∶18）;柱温30℃;流速1 m L/min;波长205 nm;线性范围0.2～1.0mg/m L之间,R2=0.999 2,回收率为104%,RSD为0.96%,方法能将主峰与杂质峰有效分离,可作为5-ALA盐酸盐杂质百分含量分析方法.

英文摘要：

A HPLC method to analyze the impurities of crude 5- aminolevulinic acid（ 5-ALA） samples was established. HPLC analysis was performed with Agilent liquid chromatograph equipped with DAD detector. An Inertsil ODS- SP analytical column（ 4. 6 mm × 250 mm,5 μm） was used to separate the samples. The mobile phase was the mixture of acetonitrile and ion pair solution（ 18 ∶ 82）. Sodium octane sulfonate of 2. 16 g and monosodium phosphate of 3. 12 g were dissolved into 1 000 m L water,and then the p H value of solution was regulated to 3. 65 to be used as ion pair solution. The detection wavelength was 205 nm and the column temperature was kept at 30 ℃. The linear relationship was between 0. 2 and1. 0 mg / m L（ R2= 0. 999 2）. The average recoveries of 5- ALA was 104%（ RSD = 0.96%）. The protocol was able to separate all the compositions of crude 5- ALA,monitoring the purity of 5- ALA.