Development and validation of a liquid chromatographic method for the determination of amlodipine residues on manufacturing equipment surfaces
Tóm tắt
Từ khóa
Tài liệu tham khảo
Guide to Inspections validation of cleaning processes, Food and Drug Administration, Washington DC, 1993.
Meredith, 1992, Clinical pharmacokinetics of amlodipine, Clin. Pharmacokinet., 22, 22, 10.2165/00003088-199222010-00003
Murdoch, 1991, Amlodipine. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic use in cardiovascular disease, Drugs, 41, 478, 10.2165/00003495-199141030-00009
Feng, 2002, J. Chromatogr. Sci., 40, 49
Marzo, 2000, Arzneim. Forsch., 50, 688
Yasuda, 1996, J. Mass Spectrom., 31, 879, 10.1002/(SICI)1096-9888(199608)31:8<879::AID-JMS373>3.0.CO;2-F
European Pharmacopoeia 4th Edition, Supplement 4.2, Council of Europe, Strasbourg, France, Monograph 01/2002:1491 corr., p. 2657.
Cleaning Validation for the Pharmaceutical Industry. In: W.E. Hall (ed.), Seminar on Cleaning Validation, Zürich, Switzerland, 1998.
J.C. Miller, J.N. Miller, Statistics for Analytical Chemistry, third Ed., Ellis Horwood, New York, 1993.