Adjusting conditions for a routine reversed-phase HPLC assay, part 2: Changing separation conditions

LC-GC Europe

Volumn 18, Issue 6, 2005, Pages 324-329

  Majors, Ronald E ^a,d   Snyder, Lloyd R ^b   Dolan, John W ^c  

^a AGILENT TECHNOLOGIES   (United States)

^b LC RESOURCES   (United States)

^c BASi Northwest Laboratory   (United States)

^d AGILENT TECHNOLOGIES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACETONITRILE;

ANALYTIC METHOD; CHROMATOGRAPHY; CONCENTRATION (PARAMETERS); DRUG INDUSTRY; FLOW RATE; FOOD AND DRUG ADMINISTRATION; PH MEASUREMENT; POLICY; QUANTITATIVE ANALYSIS; REPRODUCIBILITY; REVERSED PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; REVIEW; SEPARATION TECHNIQUE; TEMPERATURE MEASUREMENT; VALIDATION PROCESS;

EID: 20444385879     PISSN: 14716577     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (14)

1. L.R. Snyder and J.W. Dolan, LC•GC Eur., 18(4), 196-203 (2005).
2. U.D. Neue et al., J. Chromatogr. A, 849, 87 (1999).
3. M. Kele and G. Guiochon, J. Chromatogr. A, 869, 181 (2000).
4. J.W. Dolan et al., J. Chromatogr. A, 960, 51 (2002).
5. L.R. Snyder, J.J. Kirkland and J.L. Glajch, Practical HPLC Method Development, 2nd ed. (WileyInterscience, New York, USA, 1997).
6. "Guidance for Industry: Bioanalytical Method Validation," FDA (May 2001).
7. "Guidance for Industry: Q2B Validation of Analytical Procedures: Methodology," ICH (November 1996).
8. The United States Pharmacopoeia, USP 28, Rockville, Maryland, USA (2005).
9. R. Cox and G. Menon, PharmEuropa, 10, 58 (1998).
10. W.B. Furman, J.G. Dorsey and L.R. Snyder, Pharm. Technol., 58 (June 1998).
11. Pharmacopeial Forum, 30(3), 1015-1017 (May/June 2004).
12. "Guidance for Industry: Analytical Procedures and Methods Validation," FDA (August 2000).
13. "Guideline for Industry: Text on Validation of Analytical Procedures," ICH-Q2A (March 1995).
14. J.W. Dolan, D.C. Lommen and L.R. Snyder, J. Chromatogr., 535, 55 (1990).