使用带光电二极管阵列检测器的反相高效液相色谱法分离和测定厄洛替尼的工艺相关杂质。

Separation and determination of process-related impurities of erlotinib using reverse-phase HPLC with a photo-diode array detector.

作者信息

Karunakara Chandrashekara, Aparna Udupi, Chandregowda Venkateshappa, Reddy Chandrasekara G

机构信息

Vittal Mallya Scientific Research Foundation, Bengaluru, India.

出版信息

Anal Sci. 2012;28(3):305-8. doi: 10.2116/analsci.28.305.

DOI:10.2116/analsci.28.305

PMID:22451373

Abstract

A simple and rapid reverse-phase high-performance liquid chromatographic (HPLC) method for the simultaneous separation and determination of erlotinib and its process-related impurities in bulk drugs has been developed. Five process-related impurities of erlotinib have been separated on an Inerstsil ODS-3V (C18) column and detected at 254 nm using a photo diode array (PDA). This HPLC method was successfully applied to the analysis of erlotinib bulk drug. The recoveries of erlotinib and process-related impurities were in the range of 92.86-106.23%, and found to be specific, precise and reliable for the determination of unreacted raw materials, intermediates in the reaction mixtures and bulk drugs.

摘要

已开发出一种简单快速的反相高效液相色谱（HPLC）方法，用于同时分离和测定原料药中的厄洛替尼及其工艺相关杂质。在Inerstsil ODS - 3V（C18）柱上分离了厄洛替尼的5种工艺相关杂质，并使用光电二极管阵列（PDA）在254 nm处进行检测。该HPLC方法已成功应用于厄洛替尼原料药的分析。厄洛替尼及其工艺相关杂质的回收率在92.86 - 106.23%范围内，并且发现该方法对于测定未反应的原料、反应混合物中的中间体和原料药具有专属性、精密度和可靠性。