Evaluation of an HPLC stability-indicating assay for bulk 2-[4-(1-hydroxy-4-(4-(hydroxydiphenylmethyl)-1-piperidinyl)-butyl)-phenyl] -2-methylpropionic acid

Journal of Liquid Chromatography and Related Technologies

Volumn 28, Issue 5, 2005, Pages 659-668

  B'Hymer, C ^a  

^a UNIVERSITY OF CINCINNATI   (United States)

Author keywords

Drug analysis; Pharmaceutical analysis; Stability indicating assay

Indexed keywords

ACETONITRILE; HYDROGEN PEROXIDE; OXIDATION; PH EFFECTS; PHASE COMPOSITION; SOLUTIONS; ULTRAVIOLET DETECTORS;

ACIDIC CONDITIONS; OXIDATIVE STRESS; SODIUM PHOSPHATE BUFFERS; ULTRAVIOLET DETECTION;

HIGH PERFORMANCE LIQUID CHROMATOGRAPHY;

2 [4 (1 HYDROXY 4 (4 HYDROXYDIPHENYLMETHYL) 1 PIPERIDINYL) BUTYL PHENYL] 2 METHYLPROPIONIC ACID; ACETONITRILE; ANTIHISTAMINIC AGENT; CARBOXYLIC ACID; PROPIONIC ACID DERIVATIVE; SODIUM DIHYDROGEN PHOSPHATE; SODIUM PERCHLORATE; UNCLASSIFIED DRUG;

ARTICLE; DRUG DEGRADATION; DRUG STABILITY; DRUG STRUCTURE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; OXIDATIVE STRESS; PH; SENSITIVITY AND SPECIFICITY; TEMPERATURE; VALIDATION PROCESS;

EID: 14644425917     PISSN: 10826076     EISSN: None     Source Type: Journal    
DOI: 10.1081/JLC-200048882     Document Type: Article

References (17)

1. Bakshi, M.; Singh, S. Development of validated stability-indicating assay methods - critical review. J. Pharma. Biomed. Anal. 2002, 28, 1011-1040.
2. Micheel, A.P.; Ko, C.Y.; Gun, H.Y. Ion chromatography method and validation for the determination of sulfate and sulfamate ions in topiramate drug substance and finished product. J. Chromatogr. B 1998, 709, 166-172.
3. Gadkareim, E.A.; Belal, F.; Abounassif, M.A.; El-Obeid, H.A.; Ibrahim, K.E.E. Photodegradation kinetic studies and stability-indicating assay of diloxanide furoate in dosage forms using high-performance liquid chromatography. J. Liq. Chromatogr. & Rel. Technol. 2002, 25 (19), 2947-2964.
4. Bakshi, M.; Singh, B.; Singh, A.; Singh, S. The ICH guidance in practice: stress degradation studies on ormidazole and development of a validated stability-indicating assay. J. Pharm. Biomed. Anal. 2001, 26, 891-897.
5. B'Hymer, C. Development of a high performance liquid chromatographic stability-indicating assay for 1-(2-Thienylethyl)-4-imidazoline-2-thione. J. Liq. Chromatogr. & Rel. Technol. 2004, 27 (14), 2189-2197.
6. Mitra, P.; Riga, A.T.; Alexander, K.S. A rapid high-performance liquid chromatographic determination of propylthiouracil. J. Liq. Chromatogr. Rel. & Technol. 2004, 27 (3), 549-558.
7. The Federal Register. International conference on harmonisation; final guidelines on stability testing of biotechnological/biological products 1996, 61 (133), 36466-36469.
8. Mazzeo, J.R.; Grumbach, E.S.; Collier, S. A four-column approach to developing stability-indicating HPLC methods. LC/GC NA 2002, 20 (6), 538-544.
9. The Federal Register. Draft guidance for industry on analytical procedures and methods validation: chemistry, manufacturing, and controls documentation 2000, 65 (169), 52776-52777.
10. Draft Guidance for Industry: Analytical Procedures and Methods Validation; U.S. Department of Health and Human Services, Food and Drug Administration: Rockville, Maryland, August 2000.
11. Gonzalez, M.A.; Estes, K.S. Pharmacokinetic overview of oral second-generation H-1 antihistamines. Int. J. Clin. Pharm. Th. 1998, 36(5), 292-300.
12. Taglialatela, M.; Castaldo, P.; Pannaccione, A.; Giorgio, G.; Genovese, A.; Marone, G.; Annunziato, L. Cardiac ion channels and antihistamines: possible mechanisms of cardiotoxicity. Clin. Exptl. Allergy 1999, 29 (suppl.3), 182-189.
13. Taglialatela, M.; Pannaccione, A.; Castaldo, P.; Giorgio, G.; Zhou, Z.L.; January, C.T.; Genovese, A.; Marone, G.; Annunziato, L. Molecular basis for the lack of HERG K+ channel block-related carditoxicity by the H-! receptor blocker cetirizine compared with other second-generation antihistamines. Mol. Pharmacol. 1998, 54 (1), 113-121.
14. Green, M.J. A practical guide to analytical method validation. Anal. Chem. 1996, 68, 305A-309A.
15. Brown, R.; Caphart, M.; Faustino, P.; Frankewich, R.; Gibbs, J.; Leutzinger, E.; Lunn, G.; Ng, L.; Rajapopalan, R.; Chiu, Y.; Sheinin, Y. Analytical procedures and method validation: highlights of the FDA's draft guidance. LC-GC N.A. 2001, 19, 74-80.
16. Swartz, M.E.; Krull, I.S. Handbook of Analytical Method Validation; Marcel Dekker, Inc.: New York, 2004.
17. Levin, S. Reversed phase stationary phases in pharmaceutical sciences. J. Liq. Chromatogr &. Relat. Technol. 2004, 27 (7-9), 1353-1376.