Synthesis of the impurities during the manufacture of bulk drug midazolam and separation of these impurities by HPLC

1. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline - Impurities: Guideline for residualsolvents: Text and Methodology Q3C(R5), Current Step 4 version, London 2011.Search in Google Scholar

2. S. Ahuja, Impurities Evaluation of Pharmaceuticals, Marcel Dekker, New York 1998, pp. 1-41.Search in Google Scholar

3. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline - Validation of Analytical Procedures:Text and Methodology Q2(R1), Current Step 4 version, London 2005.Search in Google Scholar

4. S. Gorog, M. Babjak, G. Balogh, J. Brlik, A. Csehi and F. Dravecz, Drug impurity profiling strategies, Talanta 44 (1997) 1517-1526.10.1016/S0039-9140(96)02179-0Search in Google Scholar

5. J. Claassen, L. J. Hirsch, R. G. Emerson and S. A. Mayer, Treatment of refractory status epilepticus with pentobarbital, propofol, or midazolam: A systematic review, Epilepsia 43 (2002) 146-153.10.1046/j.1528-1157.2002.28501.xSearch in Google Scholar

6. G. Hsiao, M. Y. Shen, D. S. Chou, Y. Chang, L. W. Lee, C. H. Lin and J. R. Sheu, Mechanisms of antiplatelet and antithrombotic activity of midazolam in in vitro and in vivo studies, Eur. J. Pharmacol.487 (2004) 159-166; DOI: 10.1016/j.ejphar.2004.01.026.10.1016/j.ejphar.2004.01.026Search in Google Scholar

7. D. F. Hanley and J. F. Kross, Use of midazolam in the treatment of refractory status epilepticus,Clin. Therap. 20 (1998) 1093-1105.10.1016/S0149-2918(98)80106-9Search in Google Scholar

8. E. E. Irvine, S. Cheeta, C. Lovelock and S. E. File, Tolerance to midazolam’s anxiolytic effects after short-term nicotine treatment, Neuropharmacology 40 (2001) 710-716; DOI: 10.1016/S0028-3908(00)00211-2.10.1016/S0028-3908(00)00211-2Search in Google Scholar

9. S. L. Eeckhoutd, J. P. Desager, Y. Hormansy, A. J. Winne and R. K. Verbeeck, Sensitive assay for midazolam and its metabolite 1'-hydroxy midazolam in human plasma by capillary high performance liquid chromatography, J. Chromatogr. B 710 (1998) 165-171.10.1016/S0378-4347(98)00137-6Search in Google Scholar

10. J. Jurica, M. Dostalek, J. Konecny, Z. Glatz, E. Hadasova and J. Tomandl, HPLC determination of midazolam and its three hydroxy metabolites in perfusion medium and plasma from rats, J. Chromatogr. B 852 (2007) 571-577; DOI: 10.1016/j.jchromb.2007.02.034.10.1016/j.jchromb.2007.02.034Search in Google Scholar

11. S. N. Muchohi, S. A. Ward, L. Preston, C. R. J. C. Newton, G. Edwards and G. O. Kokwaro, Determination of midazolam and its major metabolite 1’-hydroxymidazolam by high-performance liquid chromatography-electrospray mass spectrometry in plasma from children, J. Chromatogr. B 821 (2005) 1-7; DOI: 10.1016/j.jchromb.2005.03.015.10.1016/j.jchromb.2005.03.015Search in Google Scholar

12. X. Xue, M. Huang, H. Xiao, X. Qin, L. Huang, G. Zhong and H. Bi, Rapid and simultaneous measurement of midazolam, 1’-hydroxymidazolam and digoxin by liquid chromatography/ tandem mass spectrometry: Application to an in vivo study to simultaneously measure P-glycoprotein and Cytochrome P450 3A activity, J. Pharm. Biomed. Anal. 55 (2011) 187-193; DOI: 10. 1016/j.jpba.2011.01.018.Search in Google Scholar

13. M. R. Shiran, A. Gregory, A. R. Hodjegan, G. T. Tucker and M. S. Lennard, Determination of midazolam and 1’-hydroxymidazolam by liquid chromatography-mass spectrometry in plasma of patients undergoing methadone maintenance treatment, J. Chromatogr. B. 783 (2003) 303-307; DOI: 10.1016/S1570-0232(02)00673-6. 10.1016/S1570-0232(02)00673-6Search in Google Scholar