Validation of standardized high-performance thin-layer chromatographic methods for quality control and stability testing of herbals

Journal of AOAC International

Volumn 86, Issue 5, 2003, Pages 909-915

  Koll, Kathrin ^a   Reich, Eike ^b   Blatter, Anne ^b   Veit, Markus ^c  

^a FAH   (Germany)

^b CAMAG Laboratory   (Switzerland)

^c LAT GmbH   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG PRODUCTS; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; PLANTS (BOTANY); QUALITY CONTROL;

DIETARY SUPPLEMENTS; DRUG PREPARATION; HERBAL MEDICINAL PRODUCTS;

MEDICINE;

DRUG; PLANT MEDICINAL PRODUCT;

ARTICLE; CHEMISTRY; DRUG STABILITY; EVALUATION; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; METHODOLOGY; QUALITY CONTROL; REPRODUCIBILITY; SENSITIVITY AND SPECIFICITY; STANDARD;

CHROMATOGRAPHY, HIGH PRESSURE LIQUID; DRUG STABILITY; PHARMACEUTICAL PREPARATIONS; PLANT PREPARATIONS; QUALITY CONTROL; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY;

EID: 0242611002     PISSN: 10603271     EISSN: None     Source Type: Journal    
DOI: 10.1093/jaoac/86.5.909     Document Type: Article

References (13)

1. Reich, E., & Blatter, A. (2003) in Handbook of Thin-Layer Chromatography, 3rd Ed., J. Sherma & B. Fried (Eds), Marcel Dekker, Inc., New York, NY
2. EU Guideline (2000) "Note for Guidance on Specifications: Test Procedures and Acceptance Criteria for Herbal Drugs, Herbal Drug Preparations, and Herbal Medicinal Products" (CPMP/QWP/2820/00)
3. EU Guideline (2000) "Note for Guidance on Quality of Herbal Medicinal Products" (CPMP/QWP/2819/00)
4. EU Guideline (1995) "Note for Guidance on Validation of Analytical Methods: Definitions and Terminology" (CPMP/ICH/381/95; ICH Topic Q2A)
5. EU Guideline (1995) "Note for Guidance on Validation of Analytical Procedures Methodology" (CPMP/ICH/281/95; ICH Topic Q2B)
6. Wagner, H., & Bladt, S. (1996) Plant Drug Analysis: A Thin Layer Chromatography Atlas, 2nd Ed., Springer, Berlin, Germany
7. Guidance for Industry Botanical Products, http://www.fda.gov/cder/guidance/1221dft.htm
8. http://vm/cfsan.fda.gov/~dms/facgmp.html
9. Standardization of Botanical Products White Paper (2003) American Herbal Products Association (AHPA)
10. Veit, M., Auterhoff, G., Dittrich, H., Duchatsch, W., Franz, G., Gaedcke, F., Kolkmann, R., Lang, F., Malinka, J., Poetsch, F., Silber, W., Steinhoff, B., Thomas, C., & Waechter, W. (2002) Pharm. Ind. 64, 20-23
11. Rhodewald, P., Rücker, G., & Glombitza, K.W. (1994) Apothekengerechte Prüfvorschriften, Deutscher Apothekerverlag, Stuttgart, Germany
12. Ferenczi-Fodor, K., Végh, Z., Nagy-Turák, A., Renger, B., & Zeller, M. (2001) J. AOAC Int. 84, 1265-1276
13. Thiekötter, K., & Reich, E. (2002) American Herbal Pharmacopeia, Santa Cruz, CA, pp 10-14