Stress degradation studies on betahistine and development of a validated stability-indicating assay method

Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences

Volumn 869, Issue 1-2, 2008, Pages 111-117

  Khedr, Alaa ^a   Sheha, Mahmoud ^b  

^a KING ABDULAZIZ UNIVERSITY   (Saudi Arabia)

^b Biostatistics College of Science and Health Professions   (Saudi Arabia)

Author keywords

Betahistine; Betahistine N oxide; Dansyl chloride; HPLC; Photodegradation; Stability; TLC

Indexed keywords

BIOASSAY; DECOMPOSITION; FLUORESCENCE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; PHOTODEGRADATION; REACTION KINETICS;

BETAHISTINE; BETAHISTINE N-OXIDE; DANSYL CHLORIDE; TLC;

DRUG PRODUCTS;

ACETIC ACID; ACETONITRILE; BETAHISTINE; DANSYL CHLORIDE; OXYGEN;

ACCURACY; ACID BASE BALANCE; ANALYTIC METHOD; ARTICLE; CALIBRATION; CHEMICAL REACTION; DRUG DECOMPOSITION; DRUG DEGRADATION; DRUG STABILITY; ELUTION; FLUORESCENCE; HEAT; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; MOISTURE; PRIORITY JOURNAL; SEPARATION TECHNIQUE; TABLET; ULTRAVIOLET IRRADIATION; VALIDATION PROCESS;

BETAHISTINE; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; HEAT; HYDROGEN-ION CONCENTRATION; REPRODUCIBILITY OF RESULTS; TABLETS; ULTRAVIOLET RAYS; VASODILATOR AGENTS; WATER;

EID: 44749092023     PISSN: 15700232     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jchromb.2008.05.030     Document Type: Article

References (10)

1. A.C. Moffat, M. David, Clarke's Analysis of Drugs and Poisons, Pharmaceutical Press Software, Medicines Complete browser version 1.1.1586.26116, publications division of the Royal Pharmaceutical Society of Great Britain, London, 2004.
2. British Pharmacopoeia 2007 CD-ROM, version 11, Data © Crown Copyright 2007, Index+ © System Simulation Ltd., European Pharmacopoeia monograph 1665, The Stationary Office under License from the Controller of Her Majesty's Stationary Office, London, UK.
3. Chen X.Y., Zhong D.F., Duan J.L., and Yan B.X. Xenobiotica 33 (2003) 1261
4. El-Walily A.F., Razak O.A., Belal S.F., and Bakry R.S. J. Pharm. Biomed. Anal. 21 (1999) 439
5. Douglas J.F., and Hohing T.L. Experientia 34 (1978) 499
6. Unites States Pharmacopoei-USP29-NF24 Page 263, Pharmacopeial Forum: Volume No. 30 (5) (2006) 1584.
7. Guidance for Industry, Q3B(R2) Impurities in New, Drug Products, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), ICH Revision 2, July 2006.
8. Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria, (RAAPAC), FDA/CDER/OPS, June 8, 2006.
9. Q1A(R2) Stability Testing of New Drug Substances and Products, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), ICH, November 2003.
10. ICH topic Q2(R), Validation of analytical procedures: methodology. ICH Harmonized Tripartite Guidelines, November 6, 1996, CPMP/ICH/281/95, November, 2005.