| 郑伟军.HPLC梯度洗脱法测定依托咪酯乳状注射液的有关物质[J].中国药品标准,2023,24(2): |
| HPLC梯度洗脱法测定依托咪酯乳状注射液的有关物质 |
| HPLC determination of related substances in etomidate emulsion injection by gradient elution |
| 投稿时间：2022-01-12 修订日期：2023-04-03 |
| DOI： |
| 中文关键词: 高效液相色谱法 有关物质 依托咪酯 依托咪酸 |
| 英文关键词: HPLC related substances etomidate etomiacid |
| 基金项目:基金项目：广东省药品监督管理局科技创新项目（编号：2022TDZ04） |
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| 中文摘要: |
| 目的：建立测定依托咪酯乳状注射液中的有关物质的HPLC方法。 方法：色谱柱为Waters Spherisorb C8 （4.6mm×250mm，10μm）；流动相为磷酸二氢钾溶液-乙腈-80%-四氢呋喃，梯度洗脱；柱温为40oC；检测波长为220nm，采用外标法与自身对照法。结果： 依托咪酯与依托咪酸能较好分离，依托咪酸相邻各峰间分离度均大于1.5；依托咪酸的线性范围为10.0～100.0μg/mL(r=0.9999)；平均回收率（n=9）为99.5%。结果表明，B企业产品中依托咪酸的含量相对较高，其他杂质也高于A企业产品.结论： 所建方法简便快捷、专属性强、重复性好，可用于依托咪酯乳状注射液中的有关物质检查。 |
| 英文摘要: |
| Objective: To establish a HPLC method for the determination of etomidate emulsion injection. Methods: The column was Waters Spherisorb C8 (4.6mm× 250mm,10μm), the mobile phase was Monopotassium phosphate solution-acetonitrile-80% oxolane, gradient elution, the column temperature was 40oC, and the detection wavelength was 220nm. Results: Etomidate and etomiacid were well separated, the resolution of etomidate was more than 1.5, the linear range of etomiacid was 10.0-100.0μg/mL (r = 0.9999) , the average recovery was 99.5% . The results indicate that the content of etomiacid in the products of company B is relatively high, and other impurities are also higher than those in the products of company A.Conclusion: The method is simple, rapid, specific and reproducible, and can be used for the determination of Related Substances in EtomidateEmulsion Injection. |
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