Determination of four metal elements in flurbiprofen axetil lipid microsphere injection migrating from pharmaceutical glass containers by ICP-MS with standard addition method*

doi:10.16155/j.0254-1793.2023.05.17

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Chinese Journal of Pharmaceutical Analysis ›› 2023, Vol. 43 ›› Issue (5) : 867-872. DOI: 10.16155/j.0254-1793.2023.05.17

Safety Monitoring

Determination of four metal elements in flurbiprofen axetil lipid microsphere injection migrating from pharmaceutical glass containers by ICP-MS with standard addition method^*

WANG Ni, ZHANG Fang-fang, ZHOU Ya-ju^**

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Abstract

Objective: To establish a inductively coupled plasma mass spectrometry (ICP-MS) method for the determination of arsenic (As), cadmium(Cd), antimony(Sb), lead (Pb) in flurbiprofen axetil lipid microsphere injection migrating from neutral borosilicate glass ampoule, and three batches of samples were quantitatively analyzed. Methods: Samples were diluted 20 times with deionized water and directly injected. The contents of four elements were quantitated by the standard addition method. The working parameters of the ICP-MS were as follows: RF power of 1 600 W, sampling depth of 10.0 mm, carrier gas (argon) flow rate of 0.70 L·min^-1, atomizer pump speed of 0.10 r·s^-1, atomization chamber temperature of 2 ℃, compensating gas (argon) flow rate of 0.45 L·min^-1, full quantitative analysis mode was adopted. Results: The linearity was good in the range of 1-100 ng·mL^-1 for As, Cd, Sb, while it was good in the range of 5-100 ng·mL^-1for Pb. The correlation coefficients were 0.999-1.000, and the recoveries were in the range of 91%-104% with RSD less than 2%. The contents of As, Cd, Sb and Pb in the three batches were 0.61-0.79 ng·mL^-1, 0.05-0.09 ng·mL^-1, 0.51-0.90 ng·mL^-1 and 0.41-0.53 ng·mL^-1, respectively. Conclusion: The method has been validated and can be used to determine the migrating amount of As, Cd, Sb, Pb in flurbiprofen axetil lipid microsphere injection.

Key words

flurbiprofen / inductively coupled plasma mass spectrometry / standard addition method / As / Cd / Sb / Pb / package compatibility study / migrating amount

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WANG Ni, ZHANG Fang-fang, ZHOU Ya-ju. Determination of four metal elements in flurbiprofen axetil lipid microsphere injection migrating from pharmaceutical glass containers by ICP-MS with standard addition method^*[J]. Chinese Journal of Pharmaceutical Analysis, 2023, 43(5): 867-872 https://doi.org/10.16155/j.0254-1793.2023.05.17

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