| 引用本文: | 谢赞，白敏，王茉莉，王婀娜，郝卫华，史颖.HPLC测定注射用厄他培南的含量及有关物质[J].中国现代应用药学,2012,29(5):431-433. |
| XIE Zan, BAI Min, WANG Moli, WANG Enuo, HAO Weihua, SHI Ying.Determination of Ertapenem for Injection and its Related Substances by HPLC[J].Chin J Mod Appl Pharm(中国现代应用药学),2012,29(5):431-433. |
|
| 摘要: |
| 目的 建立高效液相色谱法测定注射用厄他培南含量及有关物质。方法 采用Inertsil ODS C18柱(250 mm×4.6 mm，5 μm)，0.01 mol·L-1乙酸铵溶液为流动相A，乙腈为流动相B，梯度洗脱，流速为1.0 mL·min-1，柱温25 ℃，检测波长为230 nm。结果 厄他培南在0.17~0.87 mg·mL-1内线性关系良好，r=0.999 7，最低检测浓度为17 ng·mL-1，噁嗪酮、Pro-maba、开环降解物和二聚物等有关物质在该色谱条件下均分离良好。结论 本法重现性好，专属性强，可用于测定注射用厄他培南的含量和有关物质。 |
| 关键词: 注射用厄他培南 高效液相色谱法 含量 有关物质 |
| DOI： |
| 分类号: |
| 基金项目:科技部“十一五”重大新药创制(2010ZX09401-402) |
|
| Determination of Ertapenem for Injection and its Related Substances by HPLC |
|
XIE Zan, BAI Min, WANG Moli, WANG Enuo, HAO Weihua, SHI Ying1,2
|
|
1.Shijiazhuang Pharm Group Zhongqi Pharmaceutical Technology(Shijiazhuang) Co., Ltd., Shijiazhuang 050035, China;2.Hebei Provincical Institute for Drug Control, Shijiazhuang 050011, China
|
| Abstract: |
| OBJECTIVE To develop an HPLC method for determintation of ertapenem for injection and its related substances. METHODS The column was Inertsil ODS C18 (250 mm×4.6 mm, 5 μm). Mobile phase A: 0.01 mol·L-1 ammonium acetate solution; mobile phase B: acetonitrile. The gradient elution was used with a flow rate of 1.0 mL·min-1. The column temperature was 25 ℃. The detection wavelength was 230 nm. RESULTS The calibration curve was linear in the range of 0.17-0.87 mg·mL-1(r=0.999 7). The limit of detection of ertapenem was 17 ng·mL-1. The related subatances in ertapenem sodium such as oxazinone, Pro-maba, ring-opend hydrolysis product and dimers were separated successfully. CONCLUSION This method with good reproducibility and specificity, is suitable for the determination of ertapenem for injection and its related substances. |
| Key words: ertapenem for injection RP-HPLC content related substances |
