中国临床药理学杂志2025，Vol.41Issue(4)：552-555,4.DOI:10.13699/j.cnki.1001-6821.2025.04.021
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
摘要
Abstract
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 2.09μg·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Key words
epinephrine/nonclinical drug study/test sample analysis/high performance liquid chromatography分类
医药卫生引用本文复制引用
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[J].中国临床药理学杂志,2025,41(4):552-555,4.基金项目
山西省科技合作交流专项基金资助项目(202104041101032) （202104041101032）
