高效液相色谱法测定L-肌肽原料药的含量及其有关物质  

Determination of L-Carnosine and Its Related Substances by HPLC

作　　者：韩木南[1] 陈晓辉[1] 其其格[1] 纪晓影[1] 毕开顺[1] 

机构地区：[1]沈阳药科大学药学院,沈阳110016

出　　处：《中国药学杂志》2009年第14期1111-1113,共3页Chinese Pharmaceutical Journal

摘　　要：目的建立HPLC测定L-肌肽原料药的含量并进行有关物质检查。方法采用KromasilNH2色谱柱(4.6mm×200mm,5μm),流动相为乙腈-40mmol·L-1磷酸氢二钾溶液(44∶56,磷酸调pH6.3),流速1.0mL·min-1,检测波长为210nm,柱温35℃。结果L-肌肽在9.93～99.3mg·L-1内线性关系良好(r=0.9998),平均回收率为100.5%(RSD=1.0%),检测限为1ng(S/N=3)。L-肌肽与有关物质分离良好。结论该方法操作简便、重复性好、专属性强,可用作L-肌肽原料药的含量测定和有关物质检查。OBJECTIVE To establish a HPLC method for determining the content of L-carnosine and its related substances. METHODS The determination of L-carnosine and the separation of its related substances was performed on a Kromasil NH2 column （4.6 mm×200 mm, 5 μm）.The mobile phase consisted of acetonitrile-methanol -40 mmol.Ll dibasic potassium phosphate （44 ： 56, adjusted pH to 6.3 with Phosphoric acid）.The flow rate was 1.0 mL·min^-1. Ultraviolet absorption detector was set at 210 nm and column temperature at 35 ℃. RESULTS The linearity of L-carnosine was in the range of 9.8 to 98 mg·L^-1 （r=0.999 8）. The average recovery was 100.5% with RSD of 1.0%. The related substances of L-camosine were completely separated from L-carnosine. The limit of detection （LOD） was 1 ng （S/N=3） . CONCLUSION A reproducible and specific method is provided for the determination of L-carnosine and its related substances.

关 键 词：高效液相色谱法 L-肌肽 含量测定 相关物质 

分 类 号：R917[医药卫生—药物分析学]