Article(id=1291404330444255519, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291404284806030089, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.04.021, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1721577600000, receivedDateStr=2024-07-22, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785824385510, onlineDateStr=2026-08-04, pubDate=1740672000000, pubDateStr=2025-02-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785824385510, onlineIssueDateStr=2026-08-04, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785824385510, creator=13701087609, updateTime=1785824385510, updator=13701087609, issue=Issue{id=1291404284806030089, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='4', pageStart='451', pageEnd='600', issueExtLink='null', onlineDate='null', pubDate='1740672000000', pubDateStr='2025-02-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785824374629, creator='13701087609', updateTime=1785824374629, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext=null, issueFiles=null, downloadFileDto=null}, startPage=552, endPage=555, ext={EN=ArticleExt(id=1291404330632999200, articleId=1291404330444255519, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Determination of epinephrine in epinephrine hydrochloride injection by high performance liquid chromatography, columnId=1246531413395263850, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Research Method, runingTitle=null, highlight=null, articleAbstract=
Objective

To develop a high performance liquid chromatographic method for determination of epinephrine in epinephrine hydrochloride injection.

Methods

The separation was carried out on a Waters XBridge C18 column (150.0 mm×4.6 mm, 5 μm) with isocratic elution . The mobile phase consisted of 5.0 g·L-1 potassium dihydrogen phosphate and 2.6 g·L-1 octanesulfonic acid sodium solution (adjusting pH to 3.7 by phosphoric acid) -acetonitrile (85∶15) with the flow rate of 1.0 mL·min-1, the column temperature of 40 ℃, the detection wavelength of 280 nm and the injection volume of 10 μL. The specificity, standard curve and lower limit of quantitation (LLOQ), system suitability, stability, precision and recovery were investigated.

Results

The calibration curve of epinephrine was linear in the range of 2.09 - 83.66 μg·mL-1. The standard curve of epinephrine was y=8.74×103x-2.72×103 (r=1.000 0). The LLOQ was 2.09 μg·mL-1. The system applicability was proved to be good since the relative standard deviation (RSD) of the main peak area was 0.19% and the RSD of retention time was 0.18%. The RSD of the test solution at high, medium and low concentrations was less than 0.5%, and the average recovery rate was 105.09%-107.86%. The test solution was stable within 4 h.

Conclusion

The method validation proveded that the proposed method was stable, recovery, precise and specificity, which could be used for the measurement of epinephrine in epinephrine hydrochloride injection administration preparation.

, authors=Ling-yan HE, Chen-qian WANG, Ruo-qi WANG, Hui YUAN, Yu-hao WANG, Jian-hua CHEN, Jie GAO, Xiu-jun QIN, Jian-guo LI, authorsList=Ling-yan HE, Chen-qian WANG, Ruo-qi WANG, Hui YUAN, Yu-hao WANG, Jian-hua CHEN, Jie GAO, Xiu-jun QIN, Jian-guo LI, authorCompany=null, correspAuthors=Jian-guo LI, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1291404330930794785, articleId=1291404330444255519, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=用高效液相色谱法测定肾上腺素注射液给药制剂中肾上腺素的含量, columnId=1246531413600784769, journalTitle=中国临床药理学杂志, columnName=研究方法, runingTitle=null, highlight=null, articleAbstract=
目的

建立一种高效液相色谱法测定肾上腺素注射液给药制剂中肾上腺素的浓度。

方法

用Waters XBridge C18(150.0 mm×4.6 mm,5 μm)色谱柱等度洗脱,以离子对溶液(取磷酸二氢钾5.0 g和辛烷磺酸钠2.6 g,溶于水1 000 mL中,用磷酸调节pH值至3.7)-乙腈(85∶15)为流动相,流速为1.0 mL·min-1,柱温为40 ℃,检测波长为280 nm,进样量为10 μL。考察该方法的专属性、标准曲线与定量下限、系统适用性、稳定性、精密度与回收率。

结果

肾上腺素在2.09~83.66 μg·mL-1内,线性关系良好,标准曲线方程为y=8.74×103x-2.72×103r=1.000 0),定量下限为2.09 μg·mL-1。主峰峰面积相对标准偏差(RSD)为0.19%,保留时间RSD为0.18%,系统适用性良好;高、中、低3个质量浓度的供试品溶液测定结果的RSD均小于0.5%,平均回收率为105.09%~107.86%。肾上腺素注射液供试品溶液在4 h内稳定。

结论

本方法具有良好的稳定性、回收率、精密度和专属性,适用于测定肾上腺素注射液给药制剂中肾上腺素的含量。

, authors=何灵艳, 王晨倩, 王若琪, 袁慧, 王雨豪, 陈建华, 高洁, 秦秀军, 李建国, authorsList=何灵艳, 王晨倩, 王若琪, 袁慧, 王雨豪, 陈建华, 高洁, 秦秀军, 李建国, authorCompany=null, correspAuthors=李建国, authorNote=

何灵艳(1996-),女,实习研究员,主要从事新药安全性评价的相关研究

, correspAuthorsNote=
李建国,研究员,博士生导师 Tel: (0351)2202239 E-mail:
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用高效液相色谱法测定肾上腺素注射液给药制剂中肾上腺素的含量
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何灵艳 , 王晨倩 , 王若琪 , 袁慧 , 王雨豪 , 陈建华 , 高洁 , 秦秀军 , 李建国
中国临床药理学杂志 | 研究方法 2025,41(4): 552-555
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中国临床药理学杂志 |研究方法 2025 , 41 (4) : 552 -555
用高效液相色谱法测定肾上腺素注射液给药制剂中肾上腺素的含量
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何灵艳, 王晨倩, 王若琪, 袁慧, 王雨豪, 陈建华, 高洁, 秦秀军, 李建国
作者信息
  • 中国辐射防护研究院 药物安全性评价中心、药物毒理与放射损伤药物山西省重点实验室、中核放射毒理与放射性药物临床前评价重点实验室,山西 太原 030006
通讯作者:
李建国,研究员,博士生导师 Tel: (0351)2202239 E-mail:
作者简介:

何灵艳(1996-),女,实习研究员,主要从事新药安全性评价的相关研究

Determination of epinephrine in epinephrine hydrochloride injection by high performance liquid chromatography
Ling-yan HE, Chen-qian WANG, Ruo-qi WANG, Hui YUAN, Yu-hao WANG, Jian-hua CHEN, Jie GAO, Xiu-jun QIN, Jian-guo LI
Affiliations
  • Drug Safety Evaluation Center, Shanxi Key Laboratory of Drug Toxicology and Drug for Radiation Injury, China Nuclear Key Laboratory on Radiotoxicology and Radiopharmaceutical Preclinical Evaluation, China Institute for Radiation Protection, Taiyuan 030006, Shanxi Province, China
出版时间: 2025-02-28 doi: 10.13699/j.cnki.1001-6821.2025.04.021
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目的

建立一种高效液相色谱法测定肾上腺素注射液给药制剂中肾上腺素的浓度。

方法

用Waters XBridge C18(150.0 mm×4.6 mm,5 μm)色谱柱等度洗脱,以离子对溶液(取磷酸二氢钾5.0 g和辛烷磺酸钠2.6 g,溶于水1 000 mL中,用磷酸调节pH值至3.7)-乙腈(85∶15)为流动相,流速为1.0 mL·min-1,柱温为40 ℃,检测波长为280 nm,进样量为10 μL。考察该方法的专属性、标准曲线与定量下限、系统适用性、稳定性、精密度与回收率。

结果

肾上腺素在2.09~83.66 μg·mL-1内,线性关系良好,标准曲线方程为y=8.74×103x-2.72×103r=1.000 0),定量下限为2.09 μg·mL-1。主峰峰面积相对标准偏差(RSD)为0.19%,保留时间RSD为0.18%,系统适用性良好;高、中、低3个质量浓度的供试品溶液测定结果的RSD均小于0.5%,平均回收率为105.09%~107.86%。肾上腺素注射液供试品溶液在4 h内稳定。

结论

本方法具有良好的稳定性、回收率、精密度和专属性,适用于测定肾上腺素注射液给药制剂中肾上腺素的含量。

肾上腺素  /  药物非临床研究  /  供试品分析  /  高效液相色谱法
Objective

To develop a high performance liquid chromatographic method for determination of epinephrine in epinephrine hydrochloride injection.

Methods

The separation was carried out on a Waters XBridge C18 column (150.0 mm×4.6 mm, 5 μm) with isocratic elution . The mobile phase consisted of 5.0 g·L-1 potassium dihydrogen phosphate and 2.6 g·L-1 octanesulfonic acid sodium solution (adjusting pH to 3.7 by phosphoric acid) -acetonitrile (85∶15) with the flow rate of 1.0 mL·min-1, the column temperature of 40 ℃, the detection wavelength of 280 nm and the injection volume of 10 μL. The specificity, standard curve and lower limit of quantitation (LLOQ), system suitability, stability, precision and recovery were investigated.

Results

The calibration curve of epinephrine was linear in the range of 2.09 - 83.66 μg·mL-1. The standard curve of epinephrine was y=8.74×103x-2.72×103 (r=1.000 0). The LLOQ was 2.09 μg·mL-1. The system applicability was proved to be good since the relative standard deviation (RSD) of the main peak area was 0.19% and the RSD of retention time was 0.18%. The RSD of the test solution at high, medium and low concentrations was less than 0.5%, and the average recovery rate was 105.09%-107.86%. The test solution was stable within 4 h.

Conclusion

The method validation proveded that the proposed method was stable, recovery, precise and specificity, which could be used for the measurement of epinephrine in epinephrine hydrochloride injection administration preparation.

epinephrine  /  nonclinical drug study  /  test sample analysis  /  high performance liquid chromatography
何灵艳, 王晨倩, 王若琪, 袁慧, 王雨豪, 陈建华, 高洁, 秦秀军, 李建国. 用高效液相色谱法测定肾上腺素注射液给药制剂中肾上腺素的含量. 中国临床药理学杂志, 2025 , 41 (4) : 552 -555 . DOI: 10.13699/j.cnki.1001-6821.2025.04.021
Ling-yan HE, Chen-qian WANG, Ruo-qi WANG, Hui YUAN, Yu-hao WANG, Jian-hua CHEN, Jie GAO, Xiu-jun QIN, Jian-guo LI. Determination of epinephrine in epinephrine hydrochloride injection by high performance liquid chromatography[J]. Chinese Journal of Clinical Pharmacology, 2025 , 41 (4) : 552 -555 . DOI: 10.13699/j.cnki.1001-6821.2025.04.021
  • 山西省科技合作交流专项基金资助项目(202104041101032)
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doi: 10.13699/j.cnki.1001-6821.2025.04.021
  • 接收时间:2024-07-22
  • 首发时间:2026-08-04
  • 出版时间:2025-02-28
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  • 收稿日期:2024-07-22
基金
山西省科技合作交流专项基金资助项目(202104041101032)
作者信息
    中国辐射防护研究院 药物安全性评价中心、药物毒理与放射损伤药物山西省重点实验室、中核放射毒理与放射性药物临床前评价重点实验室,山西 太原 030006

通讯作者:

李建国,研究员,博士生导师 Tel: (0351)2202239 E-mail:
参考文献
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2种不同金属材料的力学参数

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种数
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鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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