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Content determination of impurity elements in gadolinium-based contrast agent by inductively coupled plasma tandem mass spectrometry
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Bi-yu NI1, Lin CHEN2, Chao ZHENG1, Jian-hua HUANG2, Wen XIE1, **
Chinese Journal of Pharmaceutical Analysis | 2025, 45(5) : 880 - 888
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Chinese Journal of Pharmaceutical Analysis | 2025, 45(5): 880-888
Safety Monitoring
Content determination of impurity elements in gadolinium-based contrast agent by inductively coupled plasma tandem mass spectrometry
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Bi-yu NI1, Lin CHEN2, Chao ZHENG1, Jian-hua HUANG2, Wen XIE1, **
Affiliations
  • 1. The First People’s Hospital of Changde City, Changde 415003, China
  • 2. Institute of Chinese Materia Medica, Hunan Academy of Chinese Medicine, Changsha 410013, China
doi: 10.16155/j.0254-1793.2024-1229
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Objective: To meet the needs of gadolinium-based contrast agent (GBCA) analysis and testing, and to ensure drug quality and safety, a new strategy for inductively coupled plasma tandem mass spectrometry (ICP-MS/MS) determination of 12 impurity elements (Cr, Fe, Co, Ni, Cu, V, Zn, As, Cd, Ba, Sb, and Pb) in GBCA was proposed. Methods: GBCA was diluted with 2% HNO3 and directly analyzed by ICP-MS/MS. Spectral interferences from V, Cr, Fe, Co, Ni, and Cu were eliminated using cool plasma/NH3/He reaction mode. In addition,spectral interferences from Zn, As, Cd, Ba, and Sb were eliminated using hot plasma/O2/H2 reaction mode. To evaluate the accuracy and reliability of the method, the standard reference material (NIST SRM 1643f) was analyzed by comparing the method with high-resolution ICP-MS (HR-ICP-MS), and the spiked recovery experiment was conducted. Results: Under optimized conditions, the limits of detection (LOD) of the analytes were 0.014-0.86 ng · L-1, the spiked recoveries were 96.7%-105.8%, and the RSDs were 1.6%-4.0%. The HR-ICP-MS determination values were consistent with reference values of NIST SRM 1643f. Statistical analysis showed that there was no significant difference between the measured values of the two methods at a 95% confidence level. Conclusion: The analysis method is accurate, reliable, stable and high precision. The combination of ICP-MS/MS and various reaction modes under different plasma conditions has shown promotion value for multi-element analysis in GBCA and can be extended to other fields.

gadolinium-based contrast agent  /  ICP-MS/MS  /  impurity elements  /  background equivalent concentration  /  reaction mode  /  spectral interference
Bi-yu NI, Lin CHEN, Chao ZHENG, Jian-hua HUANG, Wen XIE. Content determination of impurity elements in gadolinium-based contrast agent by inductively coupled plasma tandem mass spectrometry[J]. Chinese Journal of Pharmaceutical Analysis, 2025 , 45 (5) : 880 -888 . DOI: 10.16155/j.0254-1793.2024-1229
Year 2025 volume 45 Issue 5
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doi: 10.16155/j.0254-1793.2024-1229
  • Receive Date:2024-10-28
  • Online Date:2025-12-12
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  • Received:2024-10-28
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    1. The First People’s Hospital of Changde City, Changde 415003, China
    2. Institute of Chinese Materia Medica, Hunan Academy of Chinese Medicine, Changsha 410013, China
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表12种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)

Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
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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