Selective separation, detection of zotepine and mass spectral characterization of degradants by LC–MS/MS/QTOF

ICH, Stability Testing of New Drug Substances and Products Q1A (R2), in: Proceedings of the International Conference on Harmonization, IFPMA, Geneva, 2003. WHO, 2007 CPMP, Note for Guidance on Stability Testing: Stability Testing of Existing Active Substances and Related Finished Products, Committee for Proprietary Medicinal Products, EMEA, London, 2002. TPD, Guidance for Industry Stability Testing of Existing Drug Substances and Products, Therapeutic Products Directorate, Health Canada, Ottawa, ON, 2003. Singh, 2000, Guidance on conduct of stress tests to determine inherent stability of drugs, Pharm. Tech. On-line, 24, 1 Bakshi, 2002, Development of validated stability-indicating assay methods-critical review, J. Pharm. Biomed. Anal., 28, 1011, 10.1016/S0731-7085(02)00047-X Ali, 2012, Validated stability indicating methods for determination of nitazoxanide in presence of its degradation products, J. Pharm. Anal, 2, 105, 10.1016/j.jpha.2011.11.004 Pawar, 2011, LC–UV and LC–MS evaluation of stress degradation behavior of desvenlafaxine, J. Pharm. Anal, 2, 264, 10.1016/j.jpha.2012.02.009 Ulrich, 1996, A capillary gas-liquid chromatographic method for the assay of the neuroleptic drug zotepine in human serum or plasma, J. Pharm. Biomed. Anal, 14, 441, 10.1016/0731-7085(95)01637-6 Green, 2009, Zotepine: a clinical review, Expert Opin. Drug Metab. Toxicol., 5, 181, 10.1517/17425250802670482 Kratzsch, 2003, Screening, library-assisted identification and validated quantification of fifteen neuroleptics and three of their metabolites in plasma by liquid chromatography/mass spectrometry with atmospheric pressure chemical ionization, J. Mass Spectrom., 38, 283, 10.1002/jms.440 Kirchherr, 2006, Quantitative determination of forty-eight antidepressants and antipsychotics in human serum by HPLC tandem mass spectrometry: a multi-level, single-sample approach, J. Chromatogr. B, 843, 100, 10.1016/j.jchromb.2006.05.031 Nozaki, 2009, Application of on-line electrochemistry/electrospray/tandem mass spectrometry to a quantification method for the antipsychotic drug zotepine in human serum, Anal. Sci., 25, 1197, 10.2116/analsci.25.1197 Broecker, 2011, Combined use of liquid chromatography-hybrid quadrupole time-of-flight mass spectrometry (LC-QTOF-MS) and high performance liquid chromatography with photodiode array detector (HPLC-DAD) in systematic toxicological analysis, Forensic Sci. Int., 212, 215, 10.1016/j.forsciint.2011.06.014 Nozaki, 2006, Investigation of the electrochemical oxidation products of zotepine and their fragmentation using on-line electrochemistry/electrospray ionization mass spectrometry, J. Mass Spectrom., 41, 606, 10.1002/jms.1017 Chou, 2005, Trace analysis of zotepine and its active metabolite in plasma by capillary electrophoresis with solid phase extraction and head-column field-amplified sample stacking, J. Chromatogr. A, 1087, 189, 10.1016/j.chroma.2004.11.061 Tanaka, 1996, A method for rapid determination of zotepine by gas chromatography–mass spectrometry, Ther. Drug Monit., 18, 294, 10.1097/00007691-199606000-00013 Bickeboeller-Friedrich, 2001, Screening for detection of new antidepressants, neuroleptics, hypnotics, and their metabolites in urine by GC–MS developed using rat liver microsomes, Ther. Drug Monit., 23, 61, 10.1097/00007691-200102000-00012 ICH, Photostability testing of new drug substances and products Q1B, in: Proceedings of the International Conference on Harmonization, IFPMA, Geneva, 1996. Cai, 1999, Evaluation of trifluoroacetic acid as an ion-pair reagent in the separation of small ionizable molecules by reversed-phase liquid chromatography, Anal. Chim. Acta, 399, 249, 10.1016/S0003-2670(99)00461-4 R.M. Ornaf, M.W.Dong, Key concepts of HPLC in pharmaceutical analysis, in: S. Ahuja, M.W. Dong (Eds.), Handbook of Pharmaceutical Analysis by HPLC, vol. 6, Elsevier Ltd., Oxford OX5 1GB, UK, 2005, pp. 38–39. ICH, Validation of analytical procedures: text and methodology Q2 (R1), in: Proceedings of the International Conference on Harmonization, IFPMA, Geneva, 2005. Talluri, 2012, Synchronized separation of atorvastatin—an antihyperlipidemic drug with antihypertensive, antidiabetic, antithrombotic drugs by RP-LC for determination in combined formulations, J. Pharm. Anal., 2, 285, 10.1016/j.jpha.2012.02.006 De Spiegeleer, 2012, Relative response factor determination of β-artemether degradants by a dry heat stress approach, J. Pharm. Biomed. Anal., 70, 111, 10.1016/j.jpba.2012.06.002 Smyth, 2005, Recent studies on the electrospray ionisation mass spectrometric behavior of selected nitrogen-containing drug molecules and its application to drug analysis using liquid chromatography–electrospray ionisation mass spectrometry, J. Chromatogr. B, 824, 1, 10.1016/j.jchromb.2005.07.018 Smyth, 2003, Electrospray ionisation mass spectrometric behavior of selected drugs and their metabolites, Anal. Chim. Acta, 492, 1, 10.1016/S0003-2670(02)01474-5 Schulz, 2002 Smyth, 2000, A study of the electrospray ionisation of pharmacologically significant 1,4-benzodiazepines and their subsequent fragmentation using an ion-trap mass spectrometer, Rapid Commun. Mass Spectrom., 15, 2061, 10.1002/1097-0231(20001115)14:21<2061::AID-RCM135>3.0.CO;2-8 Bruins, 1998, Mechanistic aspects of electrospray ionization, J. Chromatogr. A., 794, 345, 10.1016/S0021-9673(97)01110-2 Smyth, 2004, Anal. Chim. Acta, 506, 203, 10.1016/j.aca.2003.11.034 Tozuka, 2002, Strategy for structure elucidation of drug metabolites derived from protonated molecules and (MS)n fragmentation of zotepine, tiaramide and their metabolites, Drug Metab. Pharmacokinet., 17, 316, 10.2133/dmpk.17.316 M.A. Dyer, A. Smith, K. Aktiengesellschaft, Liquid Pharmaceutical Formulation Containing Zotepine, EP1054666 B1, November 20, 2002.