Evaluation and Application of Best Practice in Analytical Method Validation

References

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