电感耦合等离子体质谱法测定拉考沙胺注射液中10种杂质元素

ICP-MS Determination of 10 Impurity Elements in Lacosamide Injection

摘要: 拉考沙胺注射液样品用稀释剂定容至100.0 mL，采用电感耦合等离子体质谱法测定样品溶液中锂、钒、钴、镍、铜、砷、镉、锑、汞、铅等10种杂质元素的含量。采用内标法定量，10种杂质元素的检出限（3s/k）为0.002~0.040 μg·L^-1，测定下限（10s/k）为0.007~0.120 μg·L^-1。以空白样品为基体进行加标回收试验，所得回收率为95.2%~124%，测定值的相对标准偏差（n=6）为1.0%~2.5%。通过风险评估和每日最大推荐剂量，确定了拉考沙胺注射液中各杂质元素的每日允许暴露量与各杂质元素的含量限度。

Abstract: The Lacosamide injection sample was diluted to 100.0 mL with diluent. ICP-MS was applied to the determination of 10 impurity elements, i.e. Li, V, Co, Ni, Cu, As, Cd, Sb, Hg and Pb in the sample solution. Internal standard method was used for quantitative. Detection limits (3s/k) of the 10 impurity elements were in the range of 0.002-0.040 μg·L^-1 and lower limits of determination (10s/k) were in the range of 0.007-0.120 μg·L^-1. On the base of blank sample, test for recovery was made by standard addition method; values of recovery found were in the range of 95.2%-124%, with RSDs (n=6) of determined values in the range of 1.0%-2.5%. Through risk assessment and daily maximum recommended dose, the daily allowable exposure and content limit of each impurity element in Lacosamide injection were determined.