盐酸兰地洛尔原料药中基因毒性杂质的定量分析方法研究
Validation of Analysis Method of 3-Sulfonic Acid Methyl Ester and 3-Sulfonic Acid Ethyl Ester in Landiolol Hydrochloride
摘要: 文章建立了气相色谱-串联四极级杆质谱法测定3-硝基苯磺酸甲酯、3-硝基苯磺酸乙酯的方法，采用多反应监测(MRM)模式，有效地降低基质干扰，在0.05~1 µg/mL的范围内，两种目标物的线性相关系数都在0.99以上，通过方法精密度及准确度实验，样品在两个加标浓度水平下准确度均在95.0%~110.0%之间、方法精密度在1.5%~3.0%之间，准确度及精密度良好，该方法能完全满足盐酸兰地洛尔杂质中的3-硝基苯磺酸甲酯、3-硝基苯磺酸乙酯的检测。
Abstract: Analysis method of 3-sulfonic acid methyl ester and 3-sulfonic acid ethyl ester in Landiolol Hy-drochloride were established in this work. Multiple reaction monitoring was used to reduce the interference of the matrix and increase the sensitivity of the method. The linear correlation coeffi-cients of two target compounds were all above 0.99 in the concentration range of 0.05 µg/ml to 1 µg/ml. The recoveries of samples with two standard additions ranged from 95.0% to 110.0%. The precision (RSD%, n = 6) of the method was between 1.5% and 3.0%. The method was able to ana-lyze 3-sulfonic acid methyl ester and 3-sulfonic acid ethyl ester in Landiolol Hydrochloride.
文章引用：宁凡盛, 王珊珊, 李磊, 林云良, 王晓利, 陈相峰. 盐酸兰地洛尔原料药中基因毒性杂质的定量分析方法研究[J]. 分析化学进展, 2017, 7(2): 60-66. https://doi.org/10.12677/AAC.2017.72008

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