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Determination of epinephrine in epinephrine hydrochloride injection by high performance liquid chromatography
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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
Chinese Journal of Clinical Pharmacology | 2025, 41(4) : 552 - 555
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Chinese Journal of Clinical Pharmacology | 2025, 41(4): 552-555
Research Method
Determination of epinephrine in epinephrine hydrochloride injection by high performance liquid chromatography
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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
Published: 2025-02-28 doi: 10.13699/j.cnki.1001-6821.2025.04.021
Outline
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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
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
Year 2025 volume 41 Issue 4
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doi: 10.13699/j.cnki.1001-6821.2025.04.021
  • Receive Date:2024-07-22
  • Online Date:2026-08-04
  • Published:2025-02-28
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  • Received:2024-07-22
Funding
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    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
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表12种不同金属材料的力学参数

Family
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Number of
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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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