Development and validation of a liquid chromatographic method for determination of lacidipine residues on surfaces in the manufacture of pharmaceuticals

Journal of Chromatography A

Volumn 1024, Issue 1-2, 2004, Pages 115-122

  Nozal, María J ^a   Bernal, José L ^a   Jiménez, Juan J ^a   Martín, María T ^a   Diez, Francisco J ^a  

^a UNIVERSITY OF VALLADOLID   (Spain)

Author keywords

Lacidipine; Pharmaceutical analysis; Validation

Indexed keywords

DRUG THERAPY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; STAINLESS STEEL;

COTTON SWABS; DRUG STABILITY;

DRUG PRODUCTS;

ACETONITRILE; AMMONIUM ACETATE; GLASS; LACIDIPINE; METHANOL; STAINLESS STEEL; VINYL DERIVATIVE;

CONFERENCE PAPER; COTTON; DRUG IMPURITY; DRUG SOLUBILITY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; LIGHT; PRIORITY JOURNAL; TEMPERATURE; ULTRAVIOLET RADIATION; VALIDATION PROCESS;

GOSSYPIUM HIRSUTUM;

EID: 0348110619     PISSN: 00219673     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.chroma.2003.10.064     Document Type: Conference Paper

References (21)

1. Martindale, The Extra Pharmacopeia, 31st ed., Royal Pharmaceutical Society, London, 1996, p. 898.
2. Tcherdakoff P., Mallion J.M., Rahn K.H. J. Cardiovasc. Pharmacol. 25(Suppl. 3):1995;S27.
3. Lee C.R., Bryson H.M. Drugs. 48:1994;274.
4. De Filippis P., Bovina E., Da Ros L., Fiori J., Cavrini V. J. Pharm. Biomed. Anal. 27:2002;803.
5. Guide to Inspections of Validation of Cleaning Processes, Reference Material for FDA Investigators and Personnel, US Food and Drug Administration, Washington, DC, July 1993, p. 1.
6. International Conference on Harmonisation, Harmonised Tripartite Guideline Q7A: Manufacturing Practice Guideline for Active Pharmaceutical Ingredients, US Food and Drug Administration, 2000.
7. Katona Z., Vinzce L., Végh Z., Trompler A., Ferenczi K. J. Pharm. Biomed. Anal. 22:2000;349.
8. Lambropoulos J., Spanos G.A., Lazaridis N.V. J. Pharm. Biomed. Anal. 23:2000;421.
9. Mirza T., Lunn M.J., Keeley F.J., George R.C., Bodenmiller J.R. J. Pharm. Biomed. Anal. 19:1999;747.
10. Altria K.D., Creasey E., Howels J.S. J. Liq. Chromatogr. 21:1998;1093.
11. Pellegatti M., Braggio S., Sartori S., Franceschetti F., Bolelli G.F. J. Chromatogr. B. 111:1992;105.
12. Squella J.A., Iribarren A.E., Sturm J.C., Nuñez-Vergara L.J. J. AOAC Int. 82:1999;1077.
13. Meyyanathan S.N., Tresa Tonio M., Rama Sarma G.V.S., Suresh B. Indian Drugs. 36:1999;572.
14. Lopez J.A., Martinez V., Alonso R.M., Jimenez R.M. J. Chromatogr. A. 870:2000;105.
15. Hamdan M., Scandola M., Franchi D., Gaviraghi G., Tariza G. Org. Mass Spectrom. 27:1992;240.
16. Rossato P., Scandola M., Grossi P. J. Chromatogr. 647:1993;155.
17. Nozal M.J., Bernal J.L., Toribio L., Jiménez J.J., Martín M.T. J. Chromatogr. A. 870:2000;69.
18. Nozal M.J., Bernal J.L., Toribio L., Martín M.T., Diez F.J. J. Chromatogr. A. 919:2001;87.
19. Nozal M.J., Bernal J.L., Toribio L., Martín M.T., Diez F.J. J. Pharm. Biomed. Anal. 30:2002;285.
20. ICH Harmonised Tripartita Guideline Q2B, Validation of Analytical Procedures: Methodology, 1996.
21. Thompson M., Stephen L.R., Wood R. Pure Appl. Chem. 74:2002;835. (IUPAC technical report).