Validation of HPLC methods in pharmaceutical analysis

Separation Science and Technology

Volumn 6, Issue C, 2005, Pages 191-217

  Lister, Ashley S ^a  

^a PURDUE PHARMA L P   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 79957861349     PISSN: 18771718     EISSN: None     Source Type: Book Series    
DOI: 10.1016/S0149-6395(05)80051-0     Document Type: Book

References (22)

1. Federal Register 21 CFR 211, 165(e).
2. Title 21, USC Chapter 9, The Food, Drug and Cosmetic Act.
3. International Conference on Harmonisation (ICH) Q2A, Text on validation of analytical procedures; March 1995.
4. International Conference on Harmonisation (ICH) Q2B, Validation of analytical procedures: Methodology; November 1996
5. Reviewer Guidance; Validation of Chromatographic Methods, November 1994. Center for Drug Evaluation and Research, FDA, Department of Health and Human Services, 1994.
6. Guideline for Submitting Samples and Analytical Data for Methods Validation, February 1987. Center for Drugs and Biologics, FDA, Department of Health and Human Services, 1987.
7. Guidance for Industry, Analytical Procedures and Method Validation: Chemistry, Manufacturing and Controls Documentation, Draft, August 2000, Center for Drug valuation and Research, Center for Biologics Evaluation and Research, FDA, Department of Health and Human Services, 2000.
8. Guidance for Industry, Bioanalytical Method Validation, May 2001, Center for Drug Evaluation and Research, Center for Veterinary Medicine, FDA, Department of Health and Human Services, 2001
9. USP 26/NF 21; General Chapter <1225>, Validation of Compendial Methods. Rockville, MD, United States Pharmacopoeial Convention, 2003.
10. Hong, D. D. and Shah, M., Development and Validation of HPLC Stability Indicating Assays, Drug Stability Principles and Practices, 3rd ed., Marcel Decker, Inc., New ork, 2000.
11. Crowther, J. B.,Validation of Pharmaceutical Test Methods, In Handbook of Modern Pharmaceutical Analysis, Vol. 3, (Ahuja, S. and Scypinski, S., Eds.), Separation Science and Technology, Academic Press, New York, pp. 415-443, 2001.
12. Swartz, M. E. and Krull, I. S.,Analytical Method Development and Validation, Marcel Dekker, Inc., NY, USA, 1997.
13. Green, M. J.,A Practical Guide to Analytical Method Validation, Anal. Chem. News Features, 68:305-309A, 1996.
14. Kirsch, R. B.,Validation of Analytical Methods Used In Pharmaceutical Cleaning Assessment and Validation; Analytical Validation in the Pharmaceutical Industry, upplement to Pharmaceutical Technology; pp. 40-46, 1998.
15. Krull, I. and Swartz, M.;1;, Validation Viewpoint, Introduction: National and International Guidelines, LC-GC, 15(6):534-539, 1997.
16. Plackett, R. L. and Burman, J. P.,The Design of Optimum Multifactorial Experiments, Biometrika, 33:305-325, 1943-1946.
17. ASTM., El 169-89 Standard Guide for Conducting Ruggedness Tests (Plackett-Burman Design), American Society for Testing and Materials (ASTM), 100 Barr Harbor Drive, West Conshohocken, PA., 19428-2959.
18. Dong, M., Paul, R. and Gershanov, L., Getting the Peaks Perfect: System Suitability for HPLC, Today's Chemist at Work, 10(09):38-40, 42, 2001.
19. Guidance for Industry, Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances, February 1987, Center for Drug Evaluation and Research, FDA, Department of Health and Human Services, 1987.
20. ISPE Good Practice Guide: Technology Transfer, March 2003, The Society for Life Science Professionals (ISPE), 2003.
21. Hokanson, G. C., A Life Cycle Approach to the Validation of Analytical Methods During Pharmaceutical Product Development, Part II: Changes and the Need for Additional Validation, Pharm. Tech., 18( 16):92-100, 1994.
22. Rozenman, Y. and Di Bussolo, J. M., Developing Robust HPLC Separations Using an Automated Method Development System, Pharm. Tech., 10-19, 1998.