Validation of an HPLC method for the determination of CP-93,393 in CP- 93,393-1 tablets

Journal of Pharmaceutical and Biomedical Analysis

Volumn 16, Issue 6, 1998, Pages 1075-1082

  Dumont, M L ^a   Colgan, S T ^a   Reed, R H ^a   Haggan Jr , G R ^a  

^a PFIZER INC   (United States)

Author keywords

CP 93,393; Dosage form; Reversed phase chromatography; Ruggedness; Validation

Indexed keywords

ANTIDEPRESSANT AGENT; ANXIOLYTIC AGENT; SUNEPITRON; UNCLASSIFIED DRUG;

ARTICLE; DRUG DETERMINATION; DRUG FORMULATION; PRIORITY JOURNAL; REPRODUCIBILITY; REVERSED PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; TABLET;

ANTI-ANXIETY AGENTS; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; DRUG STABILITY; EXCIPIENTS; PYRAZINES; REPRODUCIBILITY OF RESULTS; ROBOTICS; SUCCINIMIDES; TABLETS;

EID: 0032006761     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0731-7085(97)00056-3     Document Type: Article

References (13)

1. [1] S.T. Colgan, R.H. Reed, M.L. Dumont, G.R. Haggan, J. Chromatogr. (1997) in press.
2. [2] United States Pharmacopeia XXIII/National Formulary XVIII, United States Pharmacopeial Convention, Inc., Rockville, MD, USA, 1994.
3. [3] ICH Harmonised Tripartate Guideline Q2A: Validation of Analytical Methods: Definitions and Terminology, Step 4, Final Draft, 26th October, 1994.
4. [4] D. Gopal, N. Grinberg, T. Dowling, H. Perpall, G. Bicker, P. Tway, J. Liq. Chromatogr. 16 (8) (1993) 1749-1768.
5. [5] B. Renger, H. Jehle, M. Fischer, W. Funk, J. Planar Chromatogr. 8 (1995) 269-278.
6. [6] E. Pina, A. Sousa, A. Brojo, J. Liq. Chromatogr. 18 (13) (1995) 2683-2693.
7. [7] F. Ortiz-Boyer, M. Tena, M. Luque de Castro, M. Valcarcel, J. Pharm. Biomed. Anal. 13 (1995) 1297-1303.
8. [8] G.P. Carr, J.C. Wahlich, J. Pharm. Biomed. Anal. 8 (1990) 613.
9. [9] T.D. Wilson, J. Pharm. Biomed. Anal. 8 (1990) 389.
10. [10] E. Debesis, J. Boehlert, T. Givand, J. Sheridan, Pharm. Tech. September (1982) 120.
11. [11] S.T. Colgan, G.R. Haggan, R.H. Reed, J. Pharm. Biomed. Anal. 14 (1996) 825.
12. [12] C. Hartmann, J. Smeyers-Verbeke, W. Penninckx, Y. Vander Heyden, P. Vankeerberghen, D.L. Massart, Anal. Chem. 67 (1995) 4491-4499.
13. [13] J.P. Foley, J.G. Dorsey, Anal. Chem. 55 (1983) 730-737.