Trace Level Quantification of Derivatized Boronic Acids by LC/MS/MS,Organic Process Research & Development

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Trace Level Quantification of Derivatized Boronic Acids by LC/MS/MS
Organic Process Research & Development ( IF 3.1 ) Pub Date : 2019-01-08 00:00:00 , DOI: 10.1021/acs.oprd.8b00377
Aaron F. Baldwin ₁ , Robert North ₁ , Shane Eisenbeis ₁

Affiliation

Boron-containing compounds are often controlled as potentially mutagenic impurities based on ICH M7 guidance in drug substances. Herein, we describe a simple method to derivatize a subset of organoborons, non-nitrogen-containing aryl boronic acids, in order to quantify trace levels remaining in a drug substance using LC/MS/MS. Through this derivatization we are able to increase the sensitivity, demonstrate linearity, and spiked analyte recovery in matrix down to low parts per million (ppm) levels. The feasibility of this method is proven as three different examples are described, two in which one boronic acid may be present in a drug substance and one where two boronic acids may be present in the final product.

中文翻译：

LC / MS / MS对痕量硼酸进行痕量定量

基于ICH M7指导原则，通常将含硼化合物控制为潜在诱变杂质。在这里，我们描述了一种简单的方法来衍生化有机硼的子集，即不含氮的芳基硼酸，以便使用LC / MS / MS量化残留在药物中的痕量水平。通过这种衍生化，我们能够提高灵敏度，显示线性度以及将基质中的分析物回收率提高到低至百万分之一（ppm）的低水平。通过描述三个不同的实例，证明了该方法的可行性，其中两个实例中的一种药物中可能存在一种硼酸，而另一种实例中的最终产品中可能存在两种硼酸。

更新日期：2019-01-08

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