Principles of Chromatography Method Development

Biochemical Analysis Tools - Methods for Bio-Molecules Studies Pub Date : 2019-10-26 DOI:10.5772/intechopen.89501

Dr. Narasimha S. Lakka, PhD, C. Kuppan

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引用次数: 15

Abstract

This chapter aims to explain the key parameters of analytical method development using the chromatography techniques which are used for the identification, separation, purification, and quantitative estimation of complex mixtures of organic compounds. Mainly, the versatile techniques of ultra − /high-performance liquid chromatography (UPLC/HPLC) are in use for the analysis of assay and organic impurities/related substances/degradation products of a drug substance or drug product or intermediate or raw material of pharmaceuticals. A suitable analytical method is developed only after evaluating the major and critical separation parameters of chromatography (examples for UPLC/HPLC are selection of diluent, wavelength, detector, stationary phase, column temperature, flow rate, solvent system, elution mode, and injection volume, etc.). The analytical method development is a process of proving the developed analytical method is suitable for its intended use for the quantitative estimation of the targeted analyte present in pharmaceutical drugs. And it mostly plays a vital role in the development and manufacture of pharmaceuticals drugs.

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色谱法发展原理“，

本章旨在解释使用色谱技术开发分析方法的关键参数，色谱技术用于鉴定，分离，纯化和复杂有机化合物混合物的定量估计。超高效液相色谱(UPLC/HPLC)的多功能技术主要用于原料药或药品中间体或原料药的测定和有机杂质/相关物质/降解产物的分析。只有对色谱法的主要分离参数和关键分离参数(如:稀释剂、波长、检测器、固定相、柱温、流速、溶剂体系、洗脱方式、进样量等的选择)进行评价后，才能开发出合适的分析方法。分析方法开发是证明所开发的分析方法适合其用于药物中存在的目标分析物的定量估计的预期用途的过程。它在药品的开发和生产中起着至关重要的作用。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Biochemical Analysis Tools - Methods for Bio-Molecules Studies

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