Analytical control of process impurities in Pazopanib hydrochloride by impurity fate mapping

Journal of Pharmaceutical and Biomedical Analysis

Volumn 52, Issue 4, 2010, Pages 493-507

  Li, Yan ^a   Liu, David Q ^a   Yang, Shawn ^a   Sudini, Ravinder ^a   McGuire, Michael A ^a   Bhanushali, Dharmesh S ^a   Kord, Alireza S ^a  

^a GLAXOSMITHKLINE   (United States)

Author keywords

Analytical control strategy; Impurity fate mapping (IFM); Impurity tracking; Pazopanib hydrochloride; Quality by design (QbD)

Indexed keywords

DIMETHYL SULFATE; PAZOPANIB; PYRIMIDINE DERIVATIVE; SULFONAMIDE;

ARTICLE; CHEMICAL STRUCTURE; DRUG IMPURITY; DRUG MANUFACTURE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; ION TRAP MASS SPECTROMETRY; METHODOLOGY; PRIORITY JOURNAL; PROTON NUCLEAR MAGNETIC RESONANCE; QUALITY CONTROL; CHEMISTRY; COMPARATIVE STUDY; DRUG CONTAMINATION; ISOLATION AND PURIFICATION; PHARMACEUTICS; PROCEDURES;

DRUG CONTAMINATION; PYRIMIDINES; SULFONAMIDES; TECHNOLOGY, PHARMACEUTICAL;

EID: 77950368349     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2010.01.043     Document Type: Article

References (31)

1. International Conference on Harmonisation, ICH Q3A (R2), Impurities in New Drug Substances, Step 4 Version, 2006.
2. Nageswara Rao R., Nagaraju V. An overview of the recent trends in development of HPLC methods for determination of impurities in drugs. J. Pharm. Biomed. Anal. 2003, 33:335-377.
3. Ahuja S. Assuring quality of drugs by monitoring impurities. Adv. Drug Deliv. Rev. 2007, 59:3-11.
4. Jacobson-Kram D., McGovern T. Toxicological overview of impurities in pharmaceutical products. Adv. Drug Deliv. Rev. 2007, 59:38-42.
5. Basak A.K., Raw A.S., Al Hakim A.H., Furness S., Samaan N.I., Grill D.S., Patel H.B., Powers R.F., Yu L. Pharmaceutical impurities: regulatory perspective for Abbreviated New Drug Applications. Adv. Drug Deliv. Rev. 2007, 59:64-72.
6. Gorog S., Babjak M., Balogh G., Brlik J., Csehi A., Dravecz F., Gazdag M., Horvath P., Lauko A., Varga K. Drug impurity profiling strategies. Talanta 1997, 44:1517-1526.
7. Dobo K.L., Greene N., Cyr M.O., Caron S., Ku W.W. The application of structured-based assessment to support safety and chemistry diligence to manage genotoxic impurities in active pharmaceutical ingredients during drug development. Reg. Toxicol. Pharm. 2006, 44:282-293.
8. Argentine M.D., Owens P.K., Olsen B.A. Strategies for the investigation and control of process-related impurities in drug substances. Adv. Drug Deliv. Rev. 2007, 59:12-28.
9. International Conference on Harmonisation, ICH Q3B (R2), Impurities in New Drug Products, Step 4 Version, 2006.
10. Yu L.X. Pharmaceutical quality by design: product and process development, understanding, and control. Pharm. Res. 2008, 25:781-791.
11. Department of Health and Human Services, U.S. Food and Drug Administration, Pharmaceutical cGMPs for the 21st Century-A Risk-based Approach, Final Report, September 2004.
12. International Conference on Harmonisation, ICH Q8 (R1), Pharm. Dev., Step 4 Version, 2008.
13. International Conference on Harmonisation, ICH Q9, Quality Risk Management, Step 4 Version, 2005.
14. Gavin P.F., Olsen B.A. A quality by design approach to impurity method development for atomoxetine hydrochloride (LY139603). J. Pharm. Biomed. Anal. 2008, 46:431-441.
15. McKenzie P., Kiang S., Tom J., Rubin A.E., Futran M. Can pharmaceutical process development become high tech. AICHE J. 2006, 52:3990-3994.
16. Zhou L., Mao B., Reamer R., Novak T., Ge Z. Impurity profile tracking for active pharmaceutical ingredients: case reports. J. Pharm. Biomed. Anal. 2007, 44:421-429.
17. Gavin P.F., Olsen B.A., Wirth D.D., Lorenz K.T. A quality evaluation strategy for multi-sourced active pharmaceutical ingredient (API) starting materials. J. Pharm. Biomed. Anal. 2006, 41:1251-1259.
18. Elder D.P., Teasdale A., Lipczynski A.M. Control and analysis of alkyl esters of alkyl and aryl sulfonic acids in novel active pharmaceutical ingredients (APIs). J. Pharm. Biomed. Anal. 2008, 46:1-8.
19. D. Bhanushali, M.A. McGuire, R. Sudini, T. Chen, S. Yang, Y. Li, A. Kord, T. Roper, Application of QbD to pazopanib hydrochloride. Part 1. Exemplification of a science-based approach to set rational specifications for impurities, Poster presented at 2009 PhRMA API Workshop, New Burnswick, NJ.
20. D. Bhanushali, M.A. McGuire, R. Sudini, T. Chen, S. Yang, Y. Li, A. Kord, T. Roper, Phil Dell'Orco, Application of QbD to pazopanib hydrochloride. Part 2: Exemplification of a science and risk-based approach to development of a control strategy for impurities, Poster presented at 2009 PhRMA API Workshop, New Burnswick, NJ.
21. Alsante K.M., Boutros P., Couturier M.A., Friedmann R.C., Harwood J.W., Horan G.J., Jensen A.J., Liu Q., Lohr L.L., Morris R., Raggon J.W., Reid G.L., Santafianos D.P., Sharp T.R., Tucker J.L., Wilcox G.E. Pharmaceutical impurity identification: a case study using a multidisciplinary approach. J. Pharm. Sci. 2004, 93:2296-2309.
22. Van Gyseghem E., Van Hemelryck S., Daszykowski M., Questier F., Massart D.L., Vander Heyden Y. Determining orthogonal chromatographic systems prior to the development of methods to characterise impurities in drug substances. J. Chromatogr. A 2003, 988:77-93.
23. Xue G., Bendick A.D., Chen R., Sekulic S.S. Automated peak tracking for comprehensive impurity profiling in orthogonal liquid chromatographic separation using mass spectrometric detection. J. Chromatogr. A 2004, 1050:159-171.
24. Niessen W.M.A. State-of-the-art in liquid chromatography-mass spectrometry. J. Chromatogr. A 1999, 856:179-197.
25. Govaerts C.J., Orwa J., van Schepdael A., Roets E., Hoogmartens J. Structure elucidation of four related substances in gramicidin with liquid chromatography/mass spectrometry. Rapid Commun. Mass Spectrum 2001, 15:128-134.
26. Sorbera L.A., Bolós J., Serradell N. Pazopanib hydrochloride. Oncolytic, angiogenesis inhibitor, VEGFR-2 tyrosine kinase inhibitor. Drugs Future 2006, 31:585-589.
27. Alsante K.M., Ando A., Brown R., Ensing J., Hatajik T.D., Kong W., Tsuda Y. The role of degradant profiling in active pharmaceutical ingredients and drug products. Adv. Drug Deliv. Rev. 2007, 59:29-37.
28. Liu D.Q., Chen T.K., McGuire M.A., Kord A.S. Analytical control of genotoxic impurities in the pazopanib hydrochloride manufacturing process. J. Pharm. Biomed. Anal. 2009, 50:144-150.
29. Li Y., Terfloth G.J., Kord A.S. A systematic approach to RP-HPLC method development in a pharmaceutical QbD environment. Am. Pharm. Rev. 2009, 12:87-95.
30. Liu D.Q., Hop C.E.C.A. Strategies for characterization of drug metabolites using liquid chromatography-tandem mass spectrometry in conjunction with chemical derivatization and on-line H/D exchange approaches. J. Pharm. Biomed. Anal. 2005, 37:1-18.
31. International Conference on Harmonisation, ICH Q2 (R1), Validation of Analytical Procedures, Step 4 Version, 2006.