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  

Determination of epinephrine in epinephrine hydrochloride injection by high performance liquid chromatography

作　　者：何灵艳 王晨倩 王若琪 袁慧[1] 王雨豪 陈建华[1] 高洁 秦秀军[1] 李建国[1] HE Ling-yan;WANG Chen-qian;WANG Ruo-qi;YUAN Hui;WANG Yu-hao;CHEN Jian-hua;GAO Jie;QIN Xiu-jun;LI Jian-guo(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)

机构地区：[1]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

出　　处：《中国临床药理学杂志》2025年第4期552-555,共4页The Chinese Journal of Clinical Pharmacology

基　　金：山西省科技合作交流专项基金资助项目(202104041101032)。

摘　　要：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 C_(18)(150.0 mm×4.6 mm,5μm)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1000 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10μL。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2.09~83.66μg·mL^(-1)内,线性关系良好,标准曲线方程为y=8.74×10^(3)x-2.72×10^(3)(r=1.0000),定量下限为2.09μg·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。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 C_(18)column(150.0 mm×4.6 mm,5μm)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 10μL.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 2.09-83.66μg·mL^(-1).The standard curve of epinephrine was y=8.74×10^(3)x-2.72×10^(3)(r=1.0000).The LLOQ was 2.09μg·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.

关 键 词：肾上腺素 药物非临床研究 供试品分析 高效液相色谱法 

分 类 号：R971.9[医药卫生—药品]