Assay and purity evaluation of CP-93,393-1 by reversed-phase liquid chromatography. A snapshot of current practices for liquid chromatography methods development and validation

Journal of Chromatography A

Volumn 764, Issue 2, 1997, Pages 233-241

  Colgan, Stephen T ^a   Reed, Robert H ^a   Dumont, Monica L ^a   Haggan, Gary R ^a  

^a PFIZER INC   (United States)

Author keywords

CP 93,393; Pharmaceutical analysis

Indexed keywords

ANTIDEPRESSANT AGENT; CP 39393 1; UNCLASSIFIED DRUG;

ACCURACY; ARTICLE; DRUG CONTROL; DRUG DETERMINATION; DRUG PURITY; PRIORITY JOURNAL; REPRODUCIBILITY; REVERSED PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; TECHNIQUE;

EID: 0031567142     PISSN: 00219673     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0021-9673(96)00898-9     Document Type: Article

References (17)

1. G.C. Hokanson, Pharm. Tech., 18 (1994) 118.
2. G.C. Hokanson, Pharm. Tech., 18 (1994) 92.
3. E. Debesis, J.P. Boehlert, T.E. Givand and J.C. Sheridan, Pharm. Tech., 6 (1982) 120.
4. M. Martin-Smith, Acta. Pharm. Jugosl., 40 (1990) 7.
5. T.D. Wilson, J. Pharm. Biomed. Anal., 8 (1990) 389.
6. P.A.D. Edwardson, G. Bhaskar and J.E. Fairbrother, J. Pharm. Biomed. Anal., 8 (1990) 929.
7. W.L. Paul, Pharm. Tech., 15 (1991) 130.
8. R.J. Bopp, T.J. Wozniak, S.L. Anliker and J. Palmer, Prog. Pharm. Biomed. Anal., 1 (1994) 315.
9. G.S. Clarke, J. Pharm. Biomed. Anal., 12 (1994) 643.
10. United States Pharmacopeia XXIII/National Formulary XVIII, United States Pharmacopeial Convention, Rockville, MD, 1994.
11. ICH Harmonised Tripartite Guideline Q2A: Validation of Analytical Methods: Definitions and Terminology. Step 4, Final Draft, 26th October 1994.
12. Drugs Directorate Guidelines, Acceptable Methods, 20th August 1993, Minister of National Health and Welfare, Health Protection Branch, Department of Health and Welfare, Canada.
13. S.T. Colgan, P.D. Hammen, K.L. Knutson and J. Bordner, J. Chromatogr. Sci., 34 (1996) 111.
14. S.T. Colgan and E.B. Pollard, LC·GC Mag., 9 (1991) 772.
15. L.R. Snyder and J.J. Kirkland, Introduction to Modern Liquid Chromatography, Wiley, New York, 1979, p. 180.
16. S.T. Colgan, G.R. Haggan and R.H. Reed, J. Pharm. Biomed. Anal., 14 (1996) 825.
17. J.P. Foley and J.G. Dorsey, Anal. Chem., 55 (1983) 730.