今日药学

2017, v.27(09) 599-601+605

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RP-HPLC法测定注射用替加环素的有关物质
Determination of Related Substances in Tigecycline for Injection by RP-HPLC

尹霞;王燕清;黄滔;
YIN Xia;WANG Yanqing;HUANG Tao;Livzon Group Pharmaceutical Research Institute;

摘要(Abstract):

目的建立反相高效液相色谱(RP-HPLC)法测定注射用替加环素的有关物质。方法采用Phenomenex Gemini C_(18)柱(4.6 mm×150 mm,3μm);以20 mmol·L~(-1)磷酸氢二钾和2.5 mmol·L~(-1)乙二胺四乙酸二钠溶液(用磷酸调节pH值至6.4)为流动相A;以乙腈为流动相B;以1.0 mL·min~(-1)的流速进行梯度洗脱;检测波长为248 nm;柱温为30℃。结果在该色谱条件下,替加环素与各杂质分离良好,主峰纯度大于998,物料基本平衡。以替加环素校正因子为1,米诺环素、9-氨基米诺环素、9-硝基米诺环素、Di-Ma-Tig、CMI校正因子分别为1.17、0.94、1.36、1.05、1.03。结论所建立的RP-HPLC法能准确测定注射用替加环素的有关物质,可用于注射用替加环素的质量控制。
OBJECTIVE To establish a method for the determiniation of related substances in tigecycline for injection by reversed-phase High Performance Liquid Chromatographic( RP-HPLC). METHODS Phenomenex Gemini C_(18)( 4.6 mm×150 mm,3 μm) was used with phosphate buffer( 20 mmol·L~(-1)dipotassium phosphate and 2. 5 mmol·L~(-1)ethylenediamine tetraacetic acid disodium,and adjust pH to 6. 4 with phosphoric acid) as mobile phase A and acetonitrile as mobile phase B. Gradient elution was adopted with a flow rate of 1. 0 mL·min~(-1). The detection wavelength was 248 nm,and column temperature was 30 ℃. RESULTS Tigecycline and impurities were completely separated. With tigecycline as reference,the relative response factor of minocycline,9-aminomycetin,9-nitro-minocycline,Di-Ma-Tig and CMI were 1.17,0.94,1.36,1.05 and 1.03,respectively. CONCLUSION The established method can be used to determine the related substances in tigecycline for injection,and can be used to control the quality of tigecycline for injection.

关键词(KeyWords): 注射用替加环素;有关物质;杂质研究;反相高效液相色谱法
tigecycline for injection;related substances;impurity research;RP-HPLC

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作者(Author): 尹霞;王燕清;黄滔;
YIN Xia;WANG Yanqing;HUANG Tao;Livzon Group Pharmaceutical Research Institute;

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