Antonovich Robert S, Keller Paul R
J Chromatogr A. 2002 Sep 20;971(1-2):159-71. doi: 10.1016/s0021-9673(02)01004-x.
An array of pharmaceutical compounds and impurities were used to investigate the applicability of atmospheric pressure ionization mass spectrometry (MS) to routinely detect coeluting impurities in HPLC (i.e. peak purity). Four drugs were individually tested against their related impurity set using a straightforward HPLC-MS peak purity strategy. For the investigated set, which represents 24 unique drug-impurity permutations, 75% of the coeluting impurities were detected at levels <1.0%, including one-third at 0.1% (%, w/w). Factors that affect the applicability of this peak purity approach are also discussed.
使用一系列药物化合物和杂质来研究大气压电离质谱法(MS)在常规检测高效液相色谱法(HPLC)中共洗脱杂质(即峰纯度)方面的适用性。采用一种简单的HPLC-MS峰纯度策略,分别针对四种药物及其相关杂质组进行了测试。对于所研究的代表24种独特药物-杂质排列组合的集合,75%的共洗脱杂质在<1.0%的水平被检测到,其中三分之一在0.1%(%,w/w)的水平。还讨论了影响这种峰纯度方法适用性的因素。