References
- Chandrashekara, K. A.; Udupi, A.; Reddy, G. C. Separation and Estimation of Process-Related Impurities of Gefitinib by Reverse-Phase High-Performance Liquid Chromatography. J. Chromatogr. Sci. 2014, 52, 799–805.
- Chandregowda, V.; Rao, G. V.; Reddy, G. C. Improved Synthesis of Gefitinib and Erlotinib Hydrochloride – Anticancer Agents. Synth. Commun. 2007, 37, 3409.
- Pao, W.; Miller, V.; Zakowski, M.; Doherty, J. Politi, W.; Sarkaria, I.; Singh, B.; Heelan, R.; Rusch, V.; Fulton, L.; Mardis, E.; Kupfer, D.; Wilson, R.; Kris, M.; Varmus, H. EGF Receptor Gene Mutations Are Common in Lung Cancers from “Never” Smokers and Are Associated with Sensitivity of Tumors to Gefitinib and Erlotinib. Proc. Natl. Acad. Sci. U.S.A. 2004, 101, 13306.
- Sordella, R.; Bell, D. W.; Haber, D. A.; Settleman, Gefitinib-Sensitizing EGFR Mutations in Lung Cancer Activate Anti-Apoptotic Pathways. J. Sci. 2004, 305, 1163.
- Chandregowda, V.; Venkateswara Rao, G.; Chandrasekara Reddy, G. One-Pot Conversion of 2-Nitrobenzonitriles to Quinazolin-4(3H)-Ones and Synthesis of Gefitinib and Erlotinib Hydrochloride. Heterocycles 2007, 71, 39.
- Food and Drug Administration, Center for Drug Evaluation and Research (CDER), ANDAs: Impurities in Drug Substances, draft guidance for industry, June 1998.
- Görög, S.; Laukó, A.; Herényi, B. Estimation of Impurity Profiles in Drugs and Related Materials. J. Pharm. Biomed. Anal. 1988, 6, 697.
- Görög, S. Chemical and Analytical Characterization of Related Organic Impurities in Drugs. Anal. Bioanal. Chem. 2003, 377, 852.
- Ratnakumari, A.; Rajeswari, A.; Sobha, K. A specific and sensitive assay for gefitinib using methods in pharmaceutical dosage forms. Pharmanest 2010, 1, 118.
- Pravalika Reddy, P.; Balram, V. M.; Krishna Mohan, G. New spectrometric methods for the estimation of gefitinib in bulk drug and formulations. Int. J. Chem. Res. 2012, 3, 1.
- Kumar, V. K.; Raju, N. A.; Begum, S.; Rao, J. S.; Satyanarayana, T. The Estimation of Gefitinib in Tablet Dosage Forms by RP-HPLC. Res. J. Pharm. Technol. 2009, 2, 341.
- Faivre, L.; Gomo, C.; Mir, O.; Taieb, F.; Schoemann-Thomas, A.; Ropert, S.; Vidal, M.; Dusser, D.; Dauphin, A.; Goldwasser, F.; Blanchet, B. A Simple HPLC-UV Method for the Simultaneous Quantification of Gefitinib and Erlotinib in Human Plasma. J. Chromatogr. B 2011, 879, 2345.
- Bai, F.; Iacono, L. C.; Johnston, B.; Stewart, C. F. Determination of Gefitinib in Plasma by Liquid Chromatography with a C12 Column and Electrospray Tandem Mass Spectrometry Detection. J. Liq. Chromatogr. Relat. Technol. 2005, 27, 2743.
- Wang, L. Z.; Lim, M. Y.-X.; Chin, T.-M.; Thuya, W.-L.; Nye, P. L.; Wong, A.; Chan, S.-Y.; Goh, B.-C.; Ho, P. C. Rapid Determination of Gefitinib and Its Main Metabolite, O-Desmethyl Gefitinib in Human Plasma Using Liquid Chromatography-Tandem Mass Spectrometry. J. Chromatogr. B 2011, 879, 2155.
- Venkataramanna, M. Identification of Degradant Impurity in Gefitinib by Using Validated RRLC Method. Am. J. Anal. Chem. 2011, 2, 75.
- ICH Harmonised Tripariate Guideline. Validation of Analytical Procedures: Text and Methodology Q2 (R1). IFPMA Geneva 2005.
- Chow, S. C. Methodologies and Recent Development. In Statistics in Drug Research Marcel Dekker Inc.: New York, 2002; Vol. 10, pp. 31–32.