Analytical Sciences
Online ISSN : 1348-2246
Print ISSN : 0910-6340
ISSN-L : 0910-6340
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Separation and Determination of Process-Related Impurities of Erlotinib Using Reverse-Phase HPLC with a Photo-Diode Array Detector
Chandrashekara KARUNAKARAUdupi APARNAVenkateshappa CHANDREGOWDAChandrasekara G. REDDY
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2012 年 28 巻 3 号 p. 305

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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.
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© 2012 by The Japan Society for Analytical Chemistry
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