Development and validation of an HPLC method for the determination of process-related impurities in pridinol mesylate, employing experimental designs

Analytica Chimica Acta

Volumn 654, Issue 2, 2009, Pages 141-147

  Bianchini, Romina M ^a   Castellano, Patricia M ^a   Kaufman, Teodoro S ^a  

^a School of Pharmaceutical and Biochemical Sciences   (Argentina)

Author keywords

Experimental design; HPLC method development; Manufacturing process impurities; Method validation; Pridinol mesylate; Quality control

Indexed keywords

EXPERIMENTAL DESIGN; HPLC METHOD DEVELOPMENT; MANUFACTURING PROCESS IMPURITIES; METHOD VALIDATION; PRIDINOL MESYLATE;

DESIGN OF EXPERIMENTS; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HIGH PRESSURE LIQUID CHROMATOGRAPHY; INDUSTRIAL ENGINEERING; POTASSIUM; PRODUCTION ENGINEERING; QUALITY ASSURANCE; QUALITY FUNCTION DEPLOYMENT; STATISTICS; TOTAL QUALITY MANAGEMENT;

QUALITY CONTROL;

2 PROPANOL; CHOLINERGIC RECEPTOR BLOCKING AGENT; PRIDINOL MESILATE;

ACCURACY; ARTICLE; CONTROLLED STUDY; DRUG DETERMINATION; DRUG IMPURITY; DRUG ISOLATION; DRUG STRUCTURE; DRUG SYNTHESIS; EXPERIMENTAL DESIGN; FLOW RATE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; PRIORITY JOURNAL; PROCESS OPTIMIZATION; QUALITY CONTROL; REPRODUCIBILITY; SEPARATION TECHNIQUE; SPECTROSCOPY; STRUCTURE ANALYSIS; ULTRAVIOLET RADIATION; VALIDATION PROCESS;

CHEMICAL PROCESSES; CHEMISTRY, PHARMACEUTICAL; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; DRUG CONTAMINATION; PIPERIDINES; REPRODUCIBILITY OF RESULTS; RESEARCH DESIGN; SPECTROPHOTOMETRY, ULTRAVIOLET; VALIDATION STUDIES AS TOPIC;

EID: 70350247683     PISSN: 00032670     EISSN: 18734324     Source Type: Journal    
DOI: 10.1016/j.aca.2009.09.022     Document Type: Article

References (26)

1. Ahuja S. Adv. Drug Deliv. Rev. 59 (2007) 3
2. International Conference on Harmonization (ICH) Guidelines, Q3A (R2): Impurities in New Drug Substances, Geneva, Switzerland, 2008.
3. Argentine D.M., Owens P.K., and Olsen B.A. Adv. Drug Deliv. Rev. 59 (2007) 12
4. Suzuki O., and Watanabe K. Drugs and Poisons in Humans. A Handbook of Practical Analysis (2005), Springer, Heidelberg
5. Svensson P., Wang K., and Arendt-Nielsen L. Eur. J. Pain 7 (2003) 449
6. Y. Takada, H. Adachi, Y. Ikeura, Patent WO96/24352, PCT/JP96/00278 (1996) to Hisamitsu Pharmaceutical Co., Inc.
7. Pipino F., Menarini C., Lombardi G., Guerzoni P., Ferrini A., Pizzoli A., Grangie A., Beltrame A., Sorbilli G., Gottardo R., and Cilento F. Eur. J. Clin. Res. 1 (1991) 55
8. Oertel W.H., and Dodel R.C. Mov. Disord. 10 (1995) 121
9. P.B. Foley, Ph.D. Thesis, Bavarian Julius Maximilian University, Würzburg, 2001.
10. Vignaduzzo S.E., Castellano P.M., and Kaufman T.S. J. Pharm. Biomed. Anal. 46 (2008) 219
11. Fassina A., Rubinacci A., and Tessari L. Int. J. Clin. Pharmacol. Res. 6 (1986) 501
12. Malanga G., and Wolff E. Spine J. 8 (2008) 173
13. van Tulder M.W., Touray T., Furlan A.D., Solway S., and Bouter L.M. Spine 28 (2003) 1978
14. Bianchini R.M., Castellano P.M., and Kaufman T.S. J. Pharm. Biomed. Anal. 48 (2008) 1151
15. United States Pharmacopeial Convention, The United States Pharmacopeia, 30th ed., Rockville, MD, 2007.
16. Kleemann A., Engel J., Kutscher B., and Reichert D. Pharmaceutical Substances: Syntheses, Patents Applications. fourth ed. (2001), Georg Thieme Verlag, Stuttgart
17. O. Eisleb, Patent DE 875,660 (1953) to Fabwerke Hoechst.
18. Tacke R., Terunuma D., Tafel A., Miihleisen M., Forth B., Waelbroeck M., Gross J., Mutschler E., Friebe T., and Lambrecht G. J. Organomet. Chem. 501 (1995) 145
19. Blicke F.F. The Mannich reaction. In: Adams R. (Ed). Organic Reactions vol. 1 (1942), Wiley, New York
20. Derringer G., and Suich R. J. Qual. Technol. 12 (1980) 214
21. International Conference on Harmonization. ICH Q2 (R1): Validation of Analytical Procedures-Text and Methodology, Geneva, Switzerland, 2005.
22. Épshtein N.A. Pharm. Chem. J. 38 (2004) 212
23. Huber L. Validation and Qualification in Analytical Laboratories. second ed. (2007), Informa HealthCare, New York
24. Rao R.N., Talluri M.V.N.K., and Shinde D.D. J. Pharm. Biomed. Anal. 47 (2008) 230
25. Huikko K., and Kostiainen R. J. Chromatogr. A 893 (2000) 411
26. British Pharmacopoeia, Her Majesty's Stationary Office, London, UK, 2007.