Separation and Determination of Process-Related Impurities of Erlotinib Using Reverse-Phase HPLC with a Photo-Diode Array Detector

Chandrashekara KARUNAKARA; Udupi APARNA; Venkateshappa CHANDREGOWDA; Chandrasekara G. REDDY

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Separation and Determination of Process-Related Impurities of Erlotinib Using Reverse-Phase HPLC with a Photo-Diode Array Detector

机译：使用光电二极管阵列检测器的反相HPLC分离和确定厄洛替尼的过程相关杂质

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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.

机译：开发了一种简单，快速的反相高效液相色谱（HPLC）方法，用于同时分离和测定散装药物中的厄洛替尼及其过程相关杂质。已在Inerstsil ODS-3V（C18）色谱柱上分离出了五种与厄洛替尼相关的工艺相关杂质，并使用光电二极管阵列（PDA）在254 nm下进行了检测。该HPLC方法已成功地用于厄洛替尼原料药的分析。厄洛替尼和与工艺有关的杂质的回收率在92.86 – 106.23％的范围内，被发现对未反应的原料，反应混合物中的中间体和原料药的测定具有特异性，精确性和可靠性。

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《Analytical Sciences》 |2012年第3期|共4页
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Chandrashekara KARUNAKARA; Udupi APARNA; Venkateshappa CHANDREGOWDA; Chandrasekara G. REDDY;
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1. Separation and Estimation of Process-Related Impurities of Gefitinib by Reverse-Phase High-Performance Liquid Chromatography [J] . Karunakara A. Chandrashekara, Aparna Udupi, Chandrasekara G. Reddy Journal of Chromatographic Science . 2014,第8期

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2. Developing an Improved UHPLC Method for Efficient Determination of European Pharmacopeia Process-Related Impurities in Ropinirole Hydrochloride Using Analytical Quality by Design Principles [J] . Tim Tome, Ale? Obreza, Zdenko ?asar Molecules . 2020,第11期

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3. Process-related impurities of eplerenone: determination and characterisation by HPLC methods and Raman spectroscopy [J] . Katarzyna Filip, Marta ?aszcz, Andrzej Le?, Journal of Pharmaceutical and Biomedical Analysis: An International Journal on All Drug-Related Topics in Pharmaceutical, Biomedical and Clinical Analysis . 2018,第期

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4. Determination of related substance of cefotiam hydrochloride for injection using reverse-phase HPLC methods [C] . Ran Zhou, Ming Chang, Fei Wang, International Conference on Medical Engineering and Bioinformatics . 2015

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5. Determination of norepinephrine in rat tissue by reversed-phase HPLC separation and amperometric detection using a boron doped nanocrystalline thin film electrode. [D] . Schaeffer, Luther Sterling. 2006

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6. Developing an Improved UHPLC Method for Efficient Determination of European Pharmacopeia Process-Related Impurities in Ropinirole Hydrochloride Using Analytical Quality by Design Principles [O] . Tim Tome, Aleš Obreza, Zdenko Časar 2020

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Separation and Determination of Process-Related Impurities of Erlotinib Using Reverse-Phase HPLC with a Photo-Diode Array Detector

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