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

被引：11

作者：

Karunakara, Chandrashekara ^{[1
]}

Aparna, Udupi ^{[1
]}

Chandregowda, Venkateshappa ^{[1
]}

Reddy, Chandrasekara G. ^{[1
]}

机构：

[1] VMSRF, Bengaluru 560076, India

来源：

ANALYTICAL SCIENCES | 2012年 / 28卷 / 03期

关键词：

MASS-SPECTROMETRY; HUMAN PLASMA; HYDROCHLORIDE; OSI-774;

D O I：

10.2116/analsci.28.305

中图分类号：

O65 [分析化学];

学科分类号：

070302 ; 081704 ;

摘要：

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.

引用

页码：305 / 308

页数：4

共 10 条

[1]

Chandregowda V, 2007, HETEROCYCLES, V71, P39

[2]

CHIADMI F, 2007, EJHP SCI, V13, P48

[3]

Conaway M. C. Prieto, 2010, J CHROMATOGR B, V878, P1059

[4] Erlotinib hydrochloride [J].

Dowell, J ;

Minna, JD ;

Kirkpatrick, P .

NATURE REVIEWS DRUG DISCOVERY, 2005, 4 (01) :13-14

[5] Simple and selective method for the determination of various tyrosine kinase inhibitors used in the clinical setting by liquid chromatography tandem mass spectrometry [J].

Honeywell, R. ;

Yarzadah, K. ;

Giovannetti, E. ;

Losekoot, N. ;

Smit, E. F. ;

Walraven, M. ;

Lind, J. S. W. ;

Tibaldi, C. ;

Verheul, H. M. ;

Peters, G. J. .

JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES, 2010, 878 (15-16) :1059-1068

[6] Liquid-chromatographic determination of erlotinib (OSI-774), an epidermal growth factor receptor tyrosine kinase inhibitor [J].

Lepper, ER ;

Swain, SM ;

Tan, AR ;

Figg, WD ;

Sparreboom, A .

JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES, 2003, 796 (01) :181-188

[7]

Pan Jiongwei, 2010, Pharmaceutics, V2, P105

[8] Validated Stability-Indicating Chromatographic Method for the Assay of Erlotinib Active Pharmaceutical Ingredient [J].

Pujeri, S. S. ;

Khader, A. M. A. ;

Seetharamappa, J. .

ANALYTICAL LETTERS, 2009, 42 (12) :1855-1867

[9] Analysis of erlotinib and its metabolites in rat tissue sections by MALDI quadrupole time-of-flight mass spectrometry [J].

Signor, Luca ;

Varesio, Emmanuel ;

Staack, Roland F. ;

Starke, Volkmar ;

Richter, Wolfgang F. ;

Hopfgartner, Gerard .

JOURNAL OF MASS SPECTROMETRY, 2007, 42 (07) :900-909

[10] Specific method for determination of OSI-774 and its metabolite OSI-420 in human plasma by using liquid chromatography-tandem mass spectrometry [J].

Zhao, M ;

He, P ;

Rudek, MA ;

Hidalgo, M ;

Baker, SD .

JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES, 2003, 793 (02) :413-420

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