Using an innovative Quality-by-Design approach for development of a stability indicating UHPLC method for ebastine in the API and pharmaceutical formulations

Journal of Pharmaceutical and Biomedical Analysis

Volumn 78-79, Issue , 2013, Pages 65-74

  Schmidt, Alexander H ^a   Molnár, Imre ^b  

^a Zebralog GmbH and Co KG   (Germany)

^b Molnár Institute for Applied Chromatography   (Germany)

Author keywords

Chromatography modeling software DryLab 4; Design Space; Ebastine; Quality by Design; UHPLC method development

Indexed keywords

2 PROPANOL; ACETIC ACID; ACETONITRILE; EBASTINE;

ARTICLE; COMPUTER MODEL; FLOW RATE; HYDROLYSIS; OXIDATION; PH; PRIORITY JOURNAL; PROCESS DESIGN; QUALITY BY DESIGN; TEMPERATURE STRESS; ULTRA PERFORMANCE LIQUID CHROMATOGRAPHY;

BUTYROPHENONES; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; HISTAMINE H1 ANTAGONISTS; LIMIT OF DETECTION; PHARMACEUTICAL PREPARATIONS; PIPERIDINES; REPRODUCIBILITY OF RESULTS;

EID: 84874532654     PISSN: 07317085     EISSN: 1873264X     Source Type: Journal    
DOI: 10.1016/j.jpba.2013.01.032     Document Type: Article

References (34)

1. Kommentar zum Europäischen Arzneibuch Ergänzungslieferung 2005, Deutscher Apotheker Verlag, Stuttgart.
2. Monograph Ebastine in the European Pharmacopoeia 2011, Deutscher Apotheker Verlag, Stuttgart. 7th ed.
3. Prabu S.L., Kumar C.D., Shirwaikar A., Shirwaikar A. Determination of ebastine in pharmaceutical formulations by HPLC. Indian J. Pharm. Sci. 2008, 70:406-407.
4. Haggag R.S., Belal T.S. Gradient HPLC-DAD determination of two pharmaceutical mixtures containing the antihistaminic drug ebastine. J. Chromatogr. Sci. 2012, 50:862-868.
5. Ibrahim F., el-Din M.K., Eid M.I., Wahba M.E. Validated stability indicating liquid chromatographic determination of ebastine in pharmaceuticals after pre column derivatization: application to tablets and content uniformity testing. Chem. Cent. J. 2011, 5:24.
6. Arend M.Z., Cardoso S.G., Hurtado F.K., Ravanello A., Lanzanova F.A. Development and validation of a stability-indicating LC method for determination of Ebastine in tablet and syrup. Chromatographia 2009, 69(Suppl (2)):195-199.
7. Kang W., Liu K.H., Ryu J.Y., Shin J.G. Simultaneous determination of ebastine and its three metabolites in plasma using liquid chromatography-tandem mass spectrometry. J. Chromatogr. B Anal. Technol. Biomed. Life Sci. 2004, 813:75-80.
8. Feng S., Jiang J., Wang P., Liu D., Hu P. Simultaneous determination of ebastine and its active metabolite (carebastine) in human plasma using LC-MS-MS. Chromatographia 2009, 70:1417-1422.
9. Sample Preparation of Pharmaceutical Dosage Forms 2011, Springer, Heidelberg. B. Nickerson (Ed.).
10. Plackett R.L., Burman J.P. The design of optimum multifactorial experiments. Biometrika 1946, 33:305-325.
11. Baranda A.B., Etxebarria N., Jimenez R.M., Alonsa R.M. Improvement of the chromatographic separation of several 1,4-dihydropyridines calcium channel antagonist dugs by experimental design. J. Chromatogr. Sci. 2005, 43:505-512.
12. Wan Raihana W.A. Optimization of analytical methods using factorial designs. Sep. Sci. 2012, 4:10-14.
13. Karmarkar S., Garber R., Genchanok Y., George S., Yang X., Hammond R. Quality by design (QbD) based development of a stability indicating HPLC method for drug and impurities. J. Chromatogr. Sci. 2011, 49:439-446.
14. Rozet E., Lebrun P., Debrus B., Hubert P. New methodology for the development of chromatographic methods with bioanalytical application. Bioanalysis 2012, 4:755-758.
15. Molnár I., Rieger H.-J., Monks K.E. Aspects of the design space in high pressure liquid chromatography method development. J. Chromatogr. A 2010, 1217:3193-3200.
16. Snyder L.R., Glajch J.L. Computer-Assisted Method Development for High Performance Liquid Chromatography 1990, Elsevier, Amsterdam.
17. J. Chromatogr. A 1989, 485:1-675. Also:.
18. Dolan J.W., Snyder L.R., Blanc T., Van Heukelem L. Selectivity differences for C18 and C8 reversed-phase columns as a function of temperature and gradient steepness, I. Optimizing selectivity and resolution. J. Chromatogr. A 2000, 897:37-50.
19. Dolan J.W., Snyder L.R., Blanc T. Selectivity differences for C18 and C8 reversed-phase columns as a function of temperature and gradient steepness, II. Minimizing column reproducibility problems. J. Chromatogr. A 2000, 897:51-63.
20. Molnar I. Computerized design of separation strategies by reversed-phase liquid chromatography: development of DryLab software. J. Chromatogr. A 2002, 965:175-194.
21. Molnár I., Monks K.E. From Csaba Horváth to quality by design: visualizing design space in selectivity exploration of HPLC separations. Chromatographia 2011, 73(Suppl (1)):5-14.
22. Jayaraman K., Alexander A.J., Hu Y., Tomasella F.P. A stepwise strategy employing automated screening and DryLab modeling for the development of robust methods for challenging high performance liquid chromatography separations: A case study. Anal. Chim. Acta 2011, 696:116-124.
23. Monks K., Molnár I., Rieger H.-J., Bogáti B., Szabó E. Quality by design: multidimensional exploration of the design space in high performance liquid chromatography method development for better robustness before validation. J. Chromatogr. A 2012, 1232:218-230.
24. Snyder L.R., Kirkland J.J., Glajch J.L. Practical HPLC Method Development 1997, Wiley-Interscience, New York. 2nd ed.
25. FDA's Pharmaceutical Current Good Manufacturing Practices (cGMPs) for the 21st Century-A risk-based approach. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/Manufacturing/QuestionsandAnswersonCurrentGoodManufacturingPracticescGMPforDrugs/UCM176374.pdf.
26. ICHQ8 (R2) International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, Topic Q8 (R2): Pharmaceutical development (2009). http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q8_R1/Step4/Q8_R2_Guideline.pdf.
27. Schmidt A.H., Molnar I. Computer-assisted optimization in the development of a high-performance liquid chromatographic method for the analysis of kava pyrones in Piper methysticum preparations. J. Chromatogr. 2002, 948:51-63.
28. Schmidt A.H. Development of an HPLC method for the determination of hydroxycinnamic acid derivates in Cimicifuga racemosa (black cohosh) extracts using an automated method development system. J. Liq. Chromatogr. Relat. Technol. 2005, 28:871-881.
29. Course Manuscript Quality by Design Principles for the Development of Analytical HPLC Methods organized by Molnár-Institute, Berlin, Germany, November 2011.
30. Neue U.D., O'Gara J.E., Mendez A. Selectivity in reversed-phase separations - influence of the stationary phase. J. Chromatogr. A 2006, 1127:161-174.
31. ® 2010. Chromatogr. Today 2010, 3:13-20.
32. Monks K.E., Rieger H.-J., Molnár I. Expanding the term Design Space in high performance liquid chromatography (I). J. Pharm. Biomed. Anal. 2011, 56:874-879.
33. ICHQ2 (R1) International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, Topic Q2 (R1): Validation of Analytical Procedures: Text and Methodology, 2005. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q2_R1/Step4/Q2_R1_Guideline.pdf.
34. Course Manuscript Quality by Design in Pharmaceutical Analysis 2012, organized by European Compliance Academy in Barcelona, Spain, October.