Abstract:

Objective To develop a method for the determination of aluminum（AI） in compound calcium gluconate oral solution by inductively coupled plasma mass spectrometry（ICP-MS），and to analyze and control the risks associated with the use of this product in different populations. Methods A 5% nitric acid solution was used as diluent，and matrix matching method was employed. Calcium of the same concentration as the test solution was added into the standard solution，and the samples were directly determined after dilution. With Scandium as the internal standard，the content of aluminum in compound calcium gluconate oral solution was determined by ICP-MS. Results The linear relationship of aluminum was good within the concentration range of 5-400 ng/mL，with a correlation coefficient of 1.000. The average recoveries of compound calcium gluconate oral solution at various concentration levels were 98.08%-102.67%，with relative standard deviation（RSD） of 0.35%-1.55%. Conclusion This method is convenient，rapid，accurate and sensitive，and can be used for the determination of aluminum in compound calcium gluconate oral solution，which can also provide reference for the determination of elemental impurities in samples with high calcium content，and for the quality control of compound calcium gluconate oral solution. Setting the limit of aluminum in compound calcium gluconate oral solution at 10 μg/mL can control the risk of using this product in people of all ages.

Key words: Inductively coupled plasma mass spectrometry, Matrix matching method, Aluminum, Compound calcium gluconate oral solution, Risk control