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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