Development and validation of a stability-indicating RP-HPLC method for determination of atomoxetine hydrochloride in tablets

Journal of AOAC International

Volumn 93, Issue 4, 2010, Pages 1207-1214

  Patel, Sejal K ^a   Patel, Natvarlal J ^a  

^a GANPAT UNIVERSITY   (India)

Author keywords

[No Author keywords available]

Indexed keywords

DEGRADATION; PARTICLE SIZE; PARTICLE SIZE ANALYSIS; STABILITY;

AMMONIUM ACETATE; CONCENTRATION RANGES; DEGRADATION PRODUCTS; DRUG SUBSTANCES; PHOTODIODE ARRAY DETECTIONS; PHOTOLYTIC CONDITIONS; STABILITY TESTS; STRESS CONDITION;

DRUG PRODUCTS;

ADRENERGIC RECEPTOR AFFECTING AGENT; ATOMOXETINE; PROPYLAMINE; TABLET;

CHEMISTRY; DRUG STABILITY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; PROCEDURES; TABLET; VALIDATION STUDY;

ADRENERGIC UPTAKE INHIBITORS; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; DRUG STABILITY; PROPYLAMINES; TABLETS;

EID: 77956153121     PISSN: 10603271     EISSN: None     Source Type: Journal    
DOI: 10.1093/jaoac/93.4.1207     Document Type: Article

References (18)

1. The Merck Index (2006) 14th Ed., M.J. O'Neil (Ed.), Merck & Co., Inc., Whitehouse Station, NJ, p. 143
2. Wilens, T.E., Biederman, J., Abrantes, A.M., & Spencer, T.J. (1996) J. Am. Acad. Child Adolesc. Psychiatry 35, 1485-1490
3. Pliszka, S.R., McCracken, J.T., & Maas, J.W. (1996) J. Am. Acad. Child. Adolesc. Psychiatry 35, 264-272
4. Guo, W., Li, W., Guo, G., Zhang, J., Zhou, B., Zhai, Y., & Wang, C. (2007) J. Chromatogr. B 854, 128-134
5. Zhu, H.-J., Wang, J.-S., Donovan, J.L., DeVane, C.L., Gibson, B.B., & Markowitz, J.S. (2007) J. Chromatogr. B 846, 351-354
6. Patel, C., Patel, M., Rani, S., Nivsarkar, M., & Padh, H. (2007) J. Chromatogr. B 850, 356-360
7. Qimin, L., Bhaskar, S., Heather, L.C., Joseph, E.Y., Richard, M.L., William, J.W., Frank, J.B., & John-Michael, S. (2005) J. Pharm. Biomed. Anal. 38, 720-733
8. Gavin, P.F., & Olsen, B.A. (2008) J. Pharm. Biomed. Anal. 46, 431-441
9. Sellers, J.A., Olsen, B.A., Owens, P.K., & Gavin, P.F. (2006) J. Pharm. Biomed. Anal. 41, 1088-1094
10. Kamat, S.S., Choudhari, V.B., Vele, V.T., & Prabhune, S.S. (2008) Chromatographia 67, 143-146
11. Nagaraju, V., & Crouch, A.M. (2008) J. Liq. Chromatogr. Relat. Technol. 31, 722-732
12. ICH (November 1996) Topic Q1C Stability Testing for New Dosage Forms, International Conference on Harmonization, Geneva, Switzerland
13. ICH (October 1994) Q2A Validation of Analytical Procedure: Methodology, International Conference on Harmonization, Geneva, Switzerland
14. ICH (October 1996) Q2B Validation of Analytical Procedure: Methodology, International Conference on Harmonization, Geneva, Switzerland
15. ICH (June 2008) Q2 (R1) Guideline on Validation of Analytical Procedures: Text and Methodology, International Conference on Harmonization, Geneva, Switzerland
16. Center for Drug Evaluation and Research (November 1994) Reviewer Guidance, Validation of Chromatographic Methods, U.S. Food and Drug Administration, Rockville, MD
17. Moffat, A.C., Osselten, M.D., & Widdop, B. (2004) Clarke's Analysis of Drugs and Poisons in Pharmaceuticals, Body Fluids and Postmortem Material, 3rd Ed., Pharmaceutical Press, London, UK, p. 1370
18. ICH (November 1996) Topic Q1B, Photo Stability Testing of New Drug Substances and Products, International Conference on Harmonization, Geneva, Switzerland