ICP-MS与石墨炉原子吸收法测定复方氨基酸注射液中铝含量的比较

目的 对测定复方氨基酸注射液系列产品中铝含量的电感耦合等离子体质谱（ICP-MS）法与石墨炉原子吸收法（GFAAS）进行比较。方法 采用塞曼偏振背景校正的GFAAS和ICP-MS法对12家企业生产的59批复方氨基酸注射液系列制剂铝离子含量进行测定。结果 GFAAS的铝离子浓度在5~40 ng·mL^-1线性关系良好，相关系数（r）为0.995 3，平均回收率为100.1%，RSD为4.80%（n=9）；ICP-MS测得的铝离子浓度在5~100 ng·mL^-1线性关系良好，相关系数（r）为0.999 9，平均回收率为104.7%，RSD为1.75%（n=9）。结论 2种方法均可用于复方氨基酸注射液制剂中铝离子含量的测定。国内该类制剂的铝离子含量不同生产企业间存在较大差异，有必要控制复方氨基酸注射液中铝的残留量。

Comparison of Graphite Furnace Atomic Absorption Spectrometry and ICP-MS for Determination of Aluminum in Compound Amino Acid Injection

OBJECTIVE To compare the determination methods for aluminum residual in Compound Amino Acid injection by graphite furnace atomic absorption spectrometry(GFAAS) and inductively coupled plasma-mass spectrometry(ICP-MS). METHODS The content of aluminum in 59 batches of Compound Amino Acid injection produced by 12 pharmaceutical companies was determined by GFAAS with polarized Zeeman background correction and ICP-MS. RESULTS There was a good linear relationship of GFAAS in the concentration range of 5-40 ng·mL^-1(r=0.995 3), and the average recovery was 100.1%, RSD=4.80%(n=9). There was a good linear relationship of ICP-MS in the concentration range of 5-100 ng·mL^-1 (r=0.999 9), and the average recovery was 104.7%, RSD=1.75%(n=9). CONCLUSION The measured values of the two methods are basically the same. There is a significant difference in residues of aluminum between the products from different manufacturers and it is necessary to control residual aluminum in Compound Amino Acid injection.