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Kromasil NH2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。
Abstract
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·L-1 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-carnosine 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
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Key words
HPLC /
L-carnosine /
quantitative determination /
related substances
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韩木南;陈晓辉;其其格;纪晓影;毕开顺.
高效液相色谱法测定L-肌肽原料药的含量及其有关物质[J]. 中国药学杂志, 2009, 44(14): 1111-1113
HN Mu-nn;CHEN Xio-hui;QI Qi-ge;JI Xio-ying;I Ki-shun.
Determination of L-Carnosine and Its Related Substances by HPLC [J]. Chinese Pharmaceutical Journal, 2009, 44(14): 1111-1113
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参考文献
[1] WANG A M,ZHOU H B,DONG Q. Carnoine, a small miraculous peptide[J].Chem Life(生命的化学),2004,24(4):314-315.
[2] GUO Y,YAN H. Preventive effect of carnosine on cataract development[J]. Eye Sci(眼科学报),2006,22(2):85-88.
[3] Ch.P(2005)VolⅡ(中国药典2005年版.二部附录)[S]. 2005:Appendix,30.
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脚注
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