ICP-MS法测定左羟丙哌嗪口服溶液中元素杂质及其包材中元素的迁移
摘要：本研究采用电感耦合等离子体质谱法建立了研究左羟丙哌嗪口服溶液与聚酯/铝/聚乙烯口服液体药用复合膜包材相容性元素杂质实验方法。使用2%的硝酸为稀释剂，以氦气为碰撞气进行测定，通过内标校正的标准曲线法进行计算。各元素在考察的浓度区间内，线性关系良好(r2>0.999)，定量限为0.0226 ~ 0.3423 ng·mL-1，平均回收率为98.33%~107.80%，精密度RSD≤5.1% (n=12)，研究结果表明，该方法灵敏度高、精密度好、准确度高，可实现左羟丙哌嗪口服溶液中元素杂质的准确定量测定。
关键词：左羟丙哌嗪；元素杂质；电感耦合等离子体质谱法
Determination
of Elemental Impurities in Levodropropizine Oral Solution and Migration of
Elements from Packaging Materials by ICP-MS
Abstract: In this study, inductively coupled plasma mass spectrometry (ICP-MS) was employed to establish a method for the determination of elemental impurities to investigate the compatibility between levodropropizine oral solution and polyester/aluminium/polyethylene composite film packaging materials for oral liquids. The analysis was performed using 2% nitric acid as the diluent and helium as the collision gas, with calculations based on the standard curve method calibrated using an internal standard. Within the concentration ranges examined, the elements exhibited good linearity (r 2> 0.999), with limits of quantification ranging from 0.0226 to 0.3423 ng·mL⁻¹,respectively, and average recoveries were 98.33% to 107.80%, with precision (RSD) ≤ 5.1% (n = 12). The results indicate that this method offers high sensitivity, good precision and high accuracy, and is capable of accurately quantifying elemental impurities in levodropropizine oral solution.
Key words: levodropropizine; elemental impurity; inductively coupled plasma mass
spectrometry
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