Method Validation

HPLC for Pharmaceutical Scientists

Volumn , Issue , 2006, Pages 455-502

  Lobrutto, Rosario ^a   Patel, Tarun ^a  

^a NOVARTIS PHARMA AG   (Switzerland)

Author keywords

Limit of detection (LOD) and limit of quantitation (LOQ); Method validation process; Validation parameter assignment

Indexed keywords

EID: 84889460543     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9780470087954.ch9     Document Type: Chapter

References (50)

1. www.ICH.gov
2. C. C. Chan, H. Lam, Y. C. Lee, X.-M. Zhang, (eds.), Analytical Method Validationand Instrument performance verification,Wiley Interscience, New York, 2004.
3. D. Paroitt, Performance verification testing of high performance liquid chromatographyequipment, LC-GC 12 (1994), 135.
4. V. Grisanti and E. Zachowski, Operation and performance qualification, LC-GC20 (2002), 355.
5. J.W. Dolan, Performance qualification of LC systems, LC-GC 20 (2002), 842.
6. M. Zooubair El Fallah, Performance verification: a regulatory burden or ananalytical tool? LC-GC 17 (1999), 343.
7. P. W. Wrezel, I. Chion, and M. S. Hussain, Validation and implementation of inprocesscontrol HPLC assays for active pharmaceutical ingredients, LC-GC NorthAm. 22 (2004), 1006-1009.
8. S. Ahuja and S. Scypinski (eds.), Handbook of Modern Pharmaceutical Analysis,Academic Press, London, 2001.
9. M. Bouma, B. Nuijen, M. T. Jansen, G. Sava, F. Picotti, A. Flaibani, A. Bult, andJ. H. Beijnen, Development of a LC method for pharmaceutical quality controlof the antimetastatic ruthenium complex NAMI-A, J. Pharm. Biomed. Anal. 31(2003), 215-228.
10. C. Akay and S. A. Ozkan, Simultaneous LC determination of trimethoprim andsulphamethoxazole in pharmaceutical formulations J. Pharm. Biomed. Anal. 30(2002), 1207-1213.
11. D. Ciutaru, I. Badea, L. Lazar,D. Nicolescu, and A.Tudose,A HPLC validated assayof paclitaxel's related impurities in pharmaceutical forms containing Cremophor®EL, J. Pharm. Biomed. Anal. 34 (2004), 493-499.
12. Y. Shao, R. Alluri, M. Mummert, U. Koetter, and S. Lech, A stability-indicatingHPLC method for the determination of glucosamine in pharmaceutical formulations,J. Pharm. Biomed. Anal. 35 (2004), 625-631.
13. N. H. Zawilla, M. A. Mohammad, N. M. El kousy, and S. M. El-Moghazy Aly,Determination of meloxicam in bulk and pharmaceutical formulations, J. Pharm.Biomed. Anal. 32 (2003), 1135-1144.
14. K. R.Tambwekar,R.B. Kakariya, and S. Garg, A validated high performance liquidchromatographic method for analysis of nicotine in pure form and from formulations,J. Pharm. Biomed. Anal. 32 (2003), 441-450.
15. A. M. Y. Jaber, H. A. Al Sherife, M. M. Al Omari, and A. A. Badwan, Determinationof cetirizine dihydrochloride, related impurities and preservatives in oralsolution and tablet dosage forms using HPLC, J. Pharm. Biomed. Anal. 36 (2004),341-350.
16. R. K. Verma, S. Garg, A validated high performance liquid chromatographicmethod for analysis of isosorbide mononitrate in bulk material and extendedrelease formulations, J. Pharm. Biomed. Anal. 30 (2002), 583-591.
17. J. Milano, L. M. Morsch, and S. G. Cardoso, LC method for the analysis ofoxiconazole in pharmaceutical formulations, J. Pharm. Biomed. Anal. 30 (2002),175-180.
18. Y. Sun, K. Takaba, H. Kido, M. N. Nakashima, and K. Nakashima, Simultaneousdetermination of arylpropionic acidic non-steroidal anti-inflammatory drugs inpharmaceutical formulations and human plasma by HPLC with UV detection,J. Pharm. Biomed. Anal. 30 (2003), 1611-1619.
19. ICH Q2A:Validation of analytical methods (definitions and terminology), 1994.
20. W. Demond, R. A. Kenley, J. L. Italien, D. Lokensgard, G. Weilersbacher, andK. Herman, Orthogonal HPLC methods for quantitating related substances anddegradation products of pramlintide, AAPS PharmSciTech 1 (2000), article 6.
21. G. Maniara, K. Rajamoorthi, S. Rajan, and G.W. Stockton, Method performanceand validation for quantitative analysis by 1H and 31P NMR spectroscopy. Applicationsto analytical standards and agricultural chemicals, Anal. Chem. 70 (1998),4921-4928.
22. D. Giron, Thermal analysis of drugs and drug products, in J. Swarbick and J. C.Boylan (eds.), Encyclopedia of Pharmaceutical Technology, Marcel Dekker, (2002),2766-2793.
23. S. Gorog, The sacred cow: The questionable role of assay methods in characterizingthe quality of bulk pharmaceuticals, J. Pharm. Biomed.Anal. 36 (2005), 931-937.
24. J.D. Orr, I. S. Krull, and M. E. Swartz,Validation of Impurity methods, Part II, LCGCNorth Am. 21 (2003), 1146-1152.
25. R. Cassidy and M. Janoski, LC-GC 10 (1992), 692.
26. C. A. Dorschel, J. L. Ekmanis, J. E. Oberholtzer, F. V. Warren, and B. A.Bidlingmeyer, Anal. Chem. 61 (1989), 951A.
27. S. Burke, Regression and calibration, LC-GC Europe Online Supplement Statisticsand Data Analysis (2001), 13-18.
28. M. M. Kiser and J.W. Dolan, Selecting the best curve fit, LC-GC Europe March(2004), 138-143.
29. J. M. Green, A practical guide to analytical method validation, Anal. Chem. 68(1996), 305A-309A.
30. Analytical Methods Committee: Is my calibration linear? AMC technical brief,No. 3, December 2000.
31. J. Erner, Chapter 2.4, in J. Ermer and J. H. McB. Miller (eds.), Method Validationin Pharmaceutical Analysis,Wiley-VCH, New York, 2005.
32. EURACHEM:The fitness for purpose of analytical methods. A Laboratory Guideto Method Validation and Related Topics. http://www.eurachem.ul.pt, 1998.
33. K. Baumann, Regression and calibration for analytical separation techniques.Part II: Validation, weighted and robust regression, Process Control and Quality10 (1997), 75-112.
34. ICH guidelines Q2B, Validation of Analytical Procedures: Methodology, November 1996.
35. http://www.labcompliance.com/methods/meth_val.htm, accessed May 16, 2006.
36. S. Klick, P. G. Muijselaar, J. Waterval, T. Eichinger, C. Korn, T. K. Gerding, A. J.Debets,C. Sanger-van de Griend,C. van den Beld,G.W. Somsen, and G. J. De Jong,Toward a generic approach for stress testing of drug substances and drug product,Pharm. Technol. February (2005), 48-66.
37. G. Boccardi, Autoxidation of drugs: prediction of degradation impurities fromresults of reactions with radical chain initiators, Il Farmaco 49 (1994), 431.
38. G. Boccardi, Oxidative susceptibility texting, Chapter 7, in S. W. Baertschi (ed.),Pharmaceutical Stress Testing: Predicting Drug Degradation, Vol. 153, Drugs andthe Pharmaceutical Sciences, Taylor and Francis, 2005.
39. M.Wasserman (eds.), Singlet Oxygen, Academic Press, New York, 1979.
40. A. A. Frimer (ed.), Singlet O2,Vols. II and III, CRC Press, Boca Raton, FL, 1985.
41. Foote, Pryor, (eds.), Free Radicals in Biology, Vol. II, Academic Press, New York,1976, 85-133.
42. R. Seburg, Photosensitized Singlet Oxygen-Mediated Degradation of anAngiotensin II Antagonist, Losartan Potassium, Merck Research Laboratories,http://www.iirusa.com/forceddegradation/files/IIR_p1038_Seburg.pdf#search='AIBN%20and%20force%20degradation%20and%20HPLC', accessed May 15,2006.
43. J. K. Guillory and R. I. Poust, Chemical kinetics and drug stability, Chapter 6 inG. S. Banker and C. T. Rhodes, Modern Pharmaceutics, 3rd ed., Marcel Dekker,New York, 1996, pp. 139-165.
44. H. H. Tønnesen, Formulation and stability testing of photolabile drugs, Int. J.Pharm. 225 (2001), 1-14.
45. E. Fasani and A. Albini, Photostability stress testing, Chapter 10 in PharmaceuticalStress Testing: Predicting Drug Degradation, edited by S.W. Baertschi, 1st edition,Vol. 153, Drugs and the Pharmaceutical Sciences Series (Taylor and Francis),2005.
46. FDA, Center for Drug Evaluation and Research, Submitting Documentation forthe Stability of Human Drugs and Biologics, Rockville, MD, February 1987.
47. S. W. Hovorka and C. Schoneich, Oxidative degradation of pharmaceuticals:Theory, mechanisms and inhibition, J. Pharm. Sci. 90 (2001), 253-269.
48. K. C.Waterman, R. C. Adami, K. M. Alsante, J. Hong, M. S. Landis, F. Lombardo,and C. J. Roberts, Stabilization of Pharmaceuticals to Oxidative Degradation,Pharm. Dev. Tech. 7 (2002), 1-32.
49. S. R. Byrn, R. R. Pfeiffer, and J.G. Stowell, Solid State Chemistry of Drugs, 2nd ed.,SSCI Inc.,West Lafayette, IN, 1999.
50. G. A. Shabir, Validation of high-performance liquid chromatography methods forpharmaceutical analysis: Understanding the differences and similarities betweenvalidation requirements of the US Food and Drug Administration, the US Pharmacopeiaand the International Conference on Harmonization, J. Chromatogr. A987 (2003), 57-66.