A validated HPLC method for determining residues of a dual active ingredient anti-malarial drug on manufacturing equipment surfaces

Journal of Pharmaceutical and Biomedical Analysis

Volumn 37, Issue 3, 2005, Pages 461-468

  Boca, Madalina Brindusa ^a   Apostolides, Zeno ^a   Pretorius, Etheresia ^a  

^a UNIVERSITY OF PRETORIA   (South Africa)

Author keywords

Anti malarial drug; Cleaning validation; Cross contamination; Pyrimethamine; Reversed phase liquid chromatography; Sulfadoxine

Indexed keywords

ANTIMALARIAL AGENT; PYRIMETHAMINE; STAINLESS STEEL; SULFADOXINE;

ARTICLE; CALCULATION; CHEMICAL ANALYSIS; CONTAMINATION; DRUG INDUSTRY; EQUIPMENT; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; PRIORITY JOURNAL; REVERSED PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; VALIDATION PROCESS;

EID: 14644422155     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2004.10.045     Document Type: Article

References (30)

1. PDA Technical Report No. 29: Points to Consider for Cleaning Validation, PDA J. Pharm. Sci. Technol. 52 (1998) 1-23.
2. R.Ch. Hwang Pharm. Technol. 24 2000 62 67
3. D.A. LeBlanc Pharm. Technol. 23 1998 136 148
4. T.M. Rossi, and R.R. Ryall C.M. Riley T.W. Rosanske Development and Validation of Analytical Methods 1996 Pergamon Press/Elsevier New York 293 302
5. F. Laban S.T.P. Pharma Pract. 7 1997 87 127
6. Guide to Inspections Validation of Cleaning Processes, Food and Drug Administration, Office of Regulatory Affairs, Washington, DC, 1993, pp. 1-6.
7. PIC/S, Recommendations on validation master plan, installation and operational qualification, non-sterile process validation, cleaning validation, PI 006-2, July 2004.
8. M.J. Nozal, J.L. Bernal, L. Toribio, M.T. Martin, and F.J. Diez J. Pharm. Biomed. Anal. 30 2002 285 291
9. J. Lambropoulos, G.A. Spanos, and N.V. Lazaridis J. Pharm. Biomed. Anal. 23 2000 421 428
10. C. Midskov J. Chromatogr. 308 1984 217 227
11. A.H. Fairlamb Parasitology 99 1989 93 112
12. C. Midskov J. Chromatogr. 306 1984 388 393
13. S.I. Bhoir, I.C. Bhoir, A.M. Bhagwat, and M. Sundaresan J. Chromatogr. B 757 2001 39 47
14. P. Parimo Indian J. Pharm. Sci. 50 1998 114 117
15. J.R. Harris, G. Baker, and J.W. Munday Analyst 102 1977 873 876
16. K. Bangchang, P. Tan-ariya, R. Ubalee, B. Kamanikom, and J. Karbwang J. Chromatogr. B 689 1997 433 437
17. M.D. Coleman, G. Edwards, and G.W. Mihaly J. Chromatogr. 308 1984 363 369
18. S. Horii, M. Nishi, N. Oku, H. Miyakawa, and M. Tezuka J. AOAC Int. 84 2001 1031 1034
19. J.O. Onah, and J.E. Odeiani J. Pharm. Biomed. Anal. 30 2002 851 857
20. H. Astier, C. Renard, V. Cheminel, O. Soares, C. Mounier, F. Peyron, and J.F. Chaulet J. Chromatogr. B 698 1997 217 223
21. M.D. Green, D.L. Mount, and H. Nettey J. Chromatogr. B 767 2002 159 162
22. Y. Bergqvist, S. Eckerbom, H. Larsson, and M. Malekzadeh J. Chromatogr. 571 1991 169 177
23. M.D. Edstein, I.D. Lika, T. Chongsuphajaisiddhi, A. Sabchareon, and H.K. Webster Ther. Drug Monit. 13 1991 146 151
24. V.K. Dua, R. Sarin, and V.P. Sharma J. Pharm. Biomed. Anal. 12 1994 1317 1323
25. J. Eljaschewitsch, J. Padberg, D. Schuermann, and B. Ruf Ther. Drug Monit. 18 1996 592 597
26. J.J. Berzas, G.C. Penalvo, and F.J. Guzman J. Liq. Chrom. Rel. Technol. 22 1999 1975 1986
27. G.L. Fourman, and M.V. Müllen Pharm. Technol. 17 1993 54 60
28. M. Edstein J. Chromatogr. 305 1984 502 507
29. R.Ch. Hwang, D.L. Kowalski, and J.E. Truelove Pharm. Technol. 23 1997 62 68
30. I. Krull, and M. Swartz LC-GC 17 1999 1016 1019