Đang chuẩn bị nút TẢI XUỐNG, xin hãy chờ
Tải xuống
Introduction to Modern Liquid Chromatography, Third Edition part 62. High-performance liquid chromatography (HPLC) is today the leading technique for chemical analysis and related applications, with an ability to separate, analyze, and/or purify virtually any sample. Snyder and Kirkland's Introduction to Modern Liquid Chromatography has long represented the premier reference to HPLC. This Third Edition, with John Dolan as added coauthor, addresses important improvements in columns and equipment, as well as major advances in our understanding of HPLC separation, our ability to solve problems that were troublesome in the past, and the application of HPLC for new kinds of samples. . | 566 METHOD VALIDATION scrutiny of any reviewer. The contents of this chapter concentrate on pharmaceutical methods but the same principles can be applied to any HPLC method so as to ensure that it is suitable for its intended use REFERENCES 1. Guidelone for SubmittinyaampleoanV Analytical Data for Methods Validation USFDA-CDER February 1987 http www.tda.gov cder guidance ameth.htm. 2. 31 NF26 lOOSUh.liiy . 3. Analytical Procedures and Methods Validation USFDA-CDER Aug. 2000 http www.fda.gov cder guidance 2396dft.htm. 4. Harmonized TridartitaGuidelioe Validation ofAnalyticall roc.ediires Text and Methodology Q2 S-RE Inlernationai Conferenccon Harmonisation Nov.2005 http www.inh.oog LOB media MEDIA017.pdf. 5. Guidance foaMelhods Developmenland Methods Validation for theResserce C02-servation an tlnocnrv irtlCi2ala. dvonstm J d EPA 1995 http www.epa.gov epawastedi aiK i t sto rthod Oin a Via . 6. ISO IEC lTO25o General RRuiremenls for the Competence of Tbsting and Calibration Laboroiorier J2OO5 . 2ttvi www.ieo.or iso iso_catalogue catalogue_tc catalogues-de0all.ftm ctnumb2r aB9883. 7. Current GooPMaGafaaluringG3acticoin ManuOactn.piepidrogtsirg Packing orHolbino Of Drugs 2L nVRPrrtVIOohttfSOrgdwLda.fov rdsr Lmpq cgmpregs.htm. 8. Current G ordMasufaauring draatiae forFioIsneaPBarmpceu2icalSid nnfinan2 A http www.fda.aavtafer dmaq eampsegs.atm. 9. International OsganizaS vn lor Standardisation http www.iso.org iso home.htm. 10. RevieweoGaiPance GGlidat foagCPifmnSagrgnIfc Mft0oge SdfeDAigaovaieibn 19f4 httpp www. id a.poe cdcr hLieaiiraOcmcl.pdr. 11. F. R. Sn.des S.a Kirmiaod n0J.O Glejch goiioizGp HdBCMethodDevelgpmenr hnd ed. Wiley-InOrrtciencc c vYorV. d fL. 12. United ntateodOarmovopoiaVOp.31-mypay l0aV8 clo.621. 13. V. P. SKah K.KJiSid iaagS. V. Dlete Pha2m.d e.iatl2g2 a88. 14. V. P. Shah1 . K.Midyii1 J.W.A. Fkidl H.M. Hill J. D. Hulse I. J. McGilvaray G. McKcy K. . R. N.Patnoid Vo J Oowell.A. Tagelil C.T.Viswe2athan.ond A. Yacobi Sda wn. di-ai. S 7 2000 dVOl. 15.
