The combination of high-performance liquid chromatography and mass spectrometry (LC/MS) has had a significant impact on drug development over the past decade. Continual improvements in LC/MS interface technologies combined with powerful features for structure analysis, qualitative and quantitative, have resulted in a widened scope of application. These improvements coincided with breakthroughs in combinatorial chemistry, molecular biology, and an overall industry trend of accelerated development. New technologies have created a situation where the rate of sample generation far exceeds the rate of sample analysis. As a result, new paradigms for the analysis of drugs and related substances have been developed. The growth in LC/MS applications has been extensive, with retention time and molecular weight emerging as essential analytical features from drug target to product. LC/MS-based methodologies that involve automation, predictive or surrogate models, and open access systems have become a permanent fixture in the drug development landscape. An iterative cycle of "what is it?" and "how much is there?" continues to fuel the tremendous growth of LC/MS in the pharmaceutical industry. During this time, LC/MS has become widely accepted as an integral part of the drug development process. This review describes the utility of LC/MS techniques for accelerated drug development and provides a perspective on the significant changes in strategies for pharmaceutical analysis. Future applications of LC/MS technologies for accelerated drug development and emerging industry trends are also discussed.

中文翻译：

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LC / MS在药物开发中的应用。

在过去十年中，高效液相色谱法和质谱分析法（LC / MS）的结合对药物开发产生了重大影响。LC / MS接口技术的不断改进，结合强大的结构分析，定性和定量功能，导致了广泛的应用范围。这些改进与组合化学，分子生物学的突破以及整个行业加速发展的趋势相吻合。新技术造成了这样一种情况，即样品的产生速度远远超过了样品分析的速度。结果，开发了用于药物和相关物质分析的新范例。LC / MS应用的增长迅速，保留时间和分子量已成为从药物靶标到产品的基本分析特征。涉及自动化，预测或替代模型以及开放获取系统的基于LC / MS的方法论已成为药物开发领域的永久性手段。“什么是迭代”的迭代周期。和“多少钱？” 继续推动制药行业LC / MS的巨大增长。在此期间，LC / MS已被广泛接受为药物开发过程的组成部分。这篇综述描述了LC / MS技术在加速药物开发中的实用性，并为药物分析策略的重大变化提供了一个视角。还讨论了LC / MS技术在加速药物开发和新兴行业趋势方面的未来应用。