Validation by Type of Method - Analytical Validation - page 163

15. Swartz, M. E., Chapter 6: Contemporary liquid chromatographic systems for method
development, in HPLC Method Development for Pharmaceuticals , Volume 8, Ahuja, S.,
Editor, Elsevier, Boston, MA 2007.
16. Neue, U. D., Walter, T. H., Alden, B. A., Jiang, Z., Fisk, R. P., Cook, J. T., Glose, K. H.,
Carmody, J. L., Grassi, J. M., Cheng, Y.-F., Lu, Z., and Crowley, R. J., Ethylene bridged
hybrids and their use in liquid chromatography, Part 1. Am. Lab ., 31, 36, 1999.
17. Cheng, Y.-F., Walter, T. H., Lu, Z., Iraneta, P., Gendreau, C., Neue, U. D., Grassi, J. M.,
Carmody, J. L., O'Gara J. E., and Fisk, R. P., Ethylene bridged hybrids and their use in
liquid chromatography, Part 2. 18, 1162, 2000.
18. Gorenstein, M. V., Li, J. B., Van Antwerp, J., and Chapman D., Detecting coeluted impu-
rities by spectral comparison. LCGC 12(10), 768-772, 1994.
19. Young, P. M. and Gorenstein, M. V., Tryptic mapping by reversed-phase HPLC with
photodiode-array detection incorporating the spectral-contrast technique. Elsevier, NY,
12(11), 832-838, 1994.
20. Warren, Wm. J., Stanick, W. A., Gorenstein, M. V., and Young, P. M., HPLC analysis of
synthetic oligonucleotides using spectral contrast techniques. BioTechniques , Informa,
London, 18(2), 282-297, 1995.
21. Swartz, M. E., UPLC: An introduction and review. J. Liq. Chrom ., 28(7&8), 1253-1263,
2005.
22. Swartz, M. E. and Murphy, B., New frontiers in chromatography; Introducing UPLC.
Am. Lab . 37(3), 22-27, 2005.
23. The Quest for Ultra Performance in Liquid Chromatography—Origins of UPLC
Technology, Waters Corporation. See http:// www.waters.com/ waters/ partDetail.
htm? cid=511539&id=38628 &ev= 10120661&locale=en_US. Last accessed February
2012.
24. Beginners Guide to UPLC—Ultra-Performance Liquid Chromatography. Waters
Corporation. See http://www.waters.com/ waters/partDetail.htm? cid=511539&id=
38629&ev=10120684&locale=en_US.
25. The United States Pharmacopeia 34/National Formulary 29 , The United States
Pharmacopeial Convention, Inc., Rockville, MD, 2011, Chapter <701>, Disintegration.
26. The United States Pharmacopeia 34/National Formulary 29 , The United States
Pharmacopeial Convention, Inc., Rockville, MD, 2011, Chapter <711>, Dissolution.
27. The United States Pharmacopeia 34/National Formulary 29 , The United States
Pharmacopeial Convention, Inc., Rockville, MD, 2011, Chapter <724>, Drug Release.
28. The United States Pharmacopeia 34/National Formulary 29 , The United States
Pharmacopeial Convention, Inc., Rockville, MD, 2011, Chapter <1092>.
29. Guidance for Industry: The Use of Mechanical Calibration of Dissolution Apparatus 1
and 2—Current Good Manufacturing Practice (CGMP), FDA Draft Guidance, October
2007. See www.fda.gov/cder/guidance/7232dft.htm.
30. FDA Division of Pharmaceutical Analysis, Mechanical Qualification of Dissolution
apparatus 1 and 2, Document # DPA-LOP.002, Version 2.0, June 2006. See http://www.
fda.gov/cder/offices/otr/dissolution.pdf.
31. AAPS PharmSciTech 2003; 4(1) article 7 (see www.pharmscitech.org).
32. The United States Pharmacopeia 34/National Formulary 29 , The United States
Pharmacopeial Convention, Inc., Rockville, MD, 2011, Chapter <621>, Chromatography.
33. Shah, V. P., Midha, K. K., Dighe, S., McGilveray, I. J., Skelly, J. P., and Yacobi, A.,
Analytical methods validation: bioavailability, bioequivalence and pharmacokinetic
studies. Conference Report. Pharm. Res., 9, 588, 1992.
34. Shah, V. P., Midha, K. K., Findlay, J. W. A., Hill, H. M., Hulse, J. D., McGilveray, I. J.,
McKay, G., Miller, K. J., Patnaik, R. N., Powell, M. L., Tionelli, A., Viswanathan, C. T.,
and Yacobi, A., Bioanalytical method validation—a revisit with a decade of progress.
Pharm. Res. , 17, 1551, 2000.