Evaluation and application of best practice in analytical method validation

Journal of Liquid Chromatography and Related Technologies

Volumn 30, Issue 3, 2007, Pages 311-333

  Shabir, Ghulam A ^a   John Lough, W ^b   Arain, Shafique A ^c   Bradshaw, Tony K ^d  

^a ABBOTT LABORATORIES   (United Kingdom)

^b UNIVERSITY OF SUNDERLAND   (United Kingdom)

^c UNIVERSITY OF STRATHCLYDE   (United Kingdom)

^d OXFORD BROOKES UNIVERSITY   (United Kingdom)

Author keywords

4 Hydroxybenzoic acid ester; Best practice; HPLC analysis; Method validation; Pharmacopoeias role; Regulatory agencies

Indexed keywords

MARKETING; MEDICAL IMAGING; ORGANIC ACIDS; REGULATORY COMPLIANCE;

ANALYTICAL METHOD; PHARMACOPOEIAS ROLE; REGULATORY AGENCIES;

HIGH PERFORMANCE LIQUID CHROMATOGRAPHY;

ANALYTIC METHOD; CAPILLARY ELECTROPHORESIS; DRUG INDUSTRY; ELECTROSPRAY MASS SPECTROMETRY; FOOD AND DRUG ADMINISTRATION; GAS CHROMATOGRAPHY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; MEDICAL LITERATURE; PRACTICE GUIDELINE; REVERSED PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; REVIEW; VALIDATION PROCESS;

EID: 33845963706     PISSN: 10826076     EISSN: 1520572X     Source Type: Journal    
DOI: 10.1080/10826070601084753     Document Type: Review

References (35)

1. Crowther, J.B. Validation of pharmaceutical test methods. In Handbook of Modern Pharmaceutical Analysis; Academic Press: California, 2001, 415-543.
2. Wilson, T.D. Liquid chromatographic methods validation for pharmaceutical products. J. Pharm. Biomed. Anal. 1990, 8, 389-400.
3. Clarke, G.S. The validation of analytical methods for drug substances and drug products in UK pharmaceutical laboratories. J. Pharm. Biomed. Anal. 1994, 12, 643-652.
4. Bressolle, F.; Petit, M.B.; Audran, M. Validation of liquid chromatographic and gas chromatographic methods: application to pharmacokinetics. J. Chromatogr. B 1996, 686, 3-10.
5. Carr, G.P.; Wahlich, J.C. A practical approach to method validation in pharmaceutical analysis. J. Pharm. Biomed. Anal. 1990, 8, 613-618.
6. Green, M.J. A practical guide to analytical method validation. Anal. Chem. 1996, 68, 305A-309A.
7. Trullols, E.; Ruisanchez, I.; Rius, F.X. Validation of qualitative analytical methods. Trends Anal. Chem. 2004, 23, 137-145.
8. Ermer, J. Validation in pharmaceutical analysis. Part 1: An integrated approach. J. Pharm. Biomed. Anal. 2001, 24, 755-767.
9. Harvey, I.M.; Baker, R.; Woodget, B. Part 2, the analytical method. In Series of Tutorial Lectures; Quality Assurance in Analytical Sciences, 2002.
10. Proceedings of the International Conference on Harmonization. Q2A: Text on validation of Analytical Procedures; ICH: Geneva, Switzerland, 1995.
11. Proceedings of the International Conference on Harmonization. Q2B: Validation of Analytical Procedures: Methodology; ICH: Geneva, Switzerland, 1997.
12. Reviewer Guidance, Validation of Chromatographic Methods; Centre for Drug Evaluation and Research, FDA: United States, 1994.
13. Guideline for Submitting Samples and Analytical Data for Methods Validation; Centre for Drug Evaluation and Research, FDA: United States, 1987.
14. U.S. Pharmacopeia 29. General Chapters (〈1225〉) Validation of Compendial Methods; United States Pharmacopeal Convention, Inc.: Rockville, Maryland, 2006, 3050.
15. U.S. Pharmacopeia 29. General Chapters (〈621〉) Chromatography; United States Pharmacopeal Convention: Rockville, Maryland, 2006, 2639.
16. Halperin, J.A. Proceedings of the second International Conference on Harmonization, Topic 3; Pharmacopoeias: Orlando, 1993.
17. Shabir, G.A. Step-by-step analytical methods validation and protocol in the quality system compliance industry. J. Validation Technol. 2004, 10 (4), 314-324.
18. Shabir, G.A. Validation of HPLC methods for pharmaceutical analysis: understanding the differences and similarities between validation requirements of the FDA, USP and ICH, J. Chromatogr. A 2003, 987, 57-66.
19. Shabir, G.A. HPLC method development and validation for pharmaceutical analysis. Pharm. Technol. 2004, 16 (3), 37-49.
20. Shabir, G.A.; Forrow, N.J. Validation of a reversed-phase HPLC method for 1,10-phenanthroline-5,6-dione and analysis of its impurities by HPLC-MS. J. Pharm. Biomed. Anal. 2003, 33, 219-230.
21. Shabir, G.A.; Forrow, N.J. Development and validation of a HPLC method for 4,7-phenanthroline-5,6-dione and identification of its impurities by HPLC-MS/APCI. J. Chromatogr. Sci. 2005, 43, 207-212.
22. Shabir, G.A. Determination of 2-(diethylamino)-N-(2,6- dimethylphenyl) acetamide in a gel pharmaceutical formulation by high-performance liquid chromatography. J. Chromatogr. Sci. 2004, 42, 280-283.
23. Shabir, G.A. Determination of combined p-hydroxy benzoic acid preservatives in a liquid pharmaceutical formulation and assay by HPLC. J. Pharm. Biomed. Anal. 2004, 34, 207-213.
24. Shabir, G.A. Method development and validation for the GC-FID assay of p-cymene in tea tree oil formulation. J. Pharm. Biomed. Anal. 2005, 39, 681-684.
25. Shabir, G. Method development and validation for the HPLC assay of hydrolysed gelatine. J. Liq. Chromatogr. & Rel. Technol. 2006, 29 (9), 1257-1270.
26. Shabir, G.; Lough, W.J.; Shafique, A.A.; Shar, G.Q. Method development and validation for the HPLC assay of phenylformic acid, 2,4-hexadienoic acid, methyl 4-hydroxybenzoate and propyl 4-hydroxybenzoate. J. Liq. Chromatogr. & Rel. Technol. 2006, 29 (9), 1223-1233.
27. Jenke, D.R. Chromatographic method validation: a review of current practices and procedures, II. Guidelines for primary validation parameters. J. Liq. Chromatogr. & Rel. Technol. 1996, 19 (5), 737-757.
28. Crowther, J.B. Validation of pharmaceutical methods. In Handbook of Modern Pharmaceuticals Analysis; Ahuja, S., Scypinski, S., Eds.; Academic Press: San Diego, 2001, 415-443.
29. Thompson, M.; Ellison, S.L.; Wood, R. Harmonised guidelines for single laboratory validation of methods of analysis (IUPAC Technical Report). Pure Appl. Chem. 2002, 74 (5), 835-855.
30. Fabre, H.; Altria, K.D. Key points for validating CE methods, particularly in pharmaceutical analysis. LCGC 2001, 19 (5), 498-505.
31. Mauricio, M.; Margaret, L.W. Regulatory issues in chromatographic analysis in the pharmaceutical industry. J. Liq. Chromatogr. & Rel. Technol. 2004, 27 (7-9), 1413-1442.
32. Rosing, H.; Man, W.Y.; Doyle, E.; Bult, A.; Beijnen, J.H. Bioanalytical liquid chromatographic method validation: a review of current practices and procedures. J. Liq. Chromatogr. & Rel. Technol. 2000, 23 (3), 329-354.
33. Grisanti, V.; Zachowski, E.J. Operational and performance qualification. LC/GC N.A. 2002, 20 (4), 356-362.
34. Zanetti, M.; Huber, L. Validating automated analytical instruments to meet regulatory and quality standard regulations. Mikrochim. Acta 1996, 123 (1-4), 23-31.
35. Hall, G.; Dolan, J.W. Performance qualification of LC systems. LC/GC N.A. 2002, 20 (9), 842-848.