Validated stability-indicating HPLC method for the determination of dimethyl-4,4′-dimethoxy-5,6,5′,6′-dimethylene dioxybiphenyl-2,2′-dicarboxylate (DDB) and its degradation products

Journal of Pharmaceutical and Biomedical Analysis

Volumn 47, Issue 4-5, 2008, Pages 695-703

  Hadad, Ghada M ^a  

^a Suez Canal University   (Egypt)

Author keywords

Arrhenius plot; DDB; HPLC; Kinetics of degradation; pH rate profile

Indexed keywords

4,4' DIMETHOXY 5,6,5',6' DIMETHYLENE DIOXYBIPHENYL 2,2' DICARBOXYLIC ACID; ACETONITRILE; BUFFER; HYDROCHLORIC ACID; HYDROGEN PEROXIDE; LIVER PROTECTIVE AGENT; SODIUM HYDROXIDE; WATER;

ACCURACY; ARTICLE; DEGRADATION KINETICS; DRUG DEGRADATION; DRUG DETERMINATION; DRUG HALF LIFE; DRUG STABILITY; HEAT; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HIGH TEMPERATURE; LINEAR SYSTEM; OXIDATION; PHOTOLYSIS; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; SAMPLE; TEMPERATURE DEPENDENCE; ULTRAVIOLET SPECTROSCOPY; VALIDATION STUDY;

ACETONITRILES; BIPHENYL COMPOUNDS; CALIBRATION; CHEMISTRY, PHARMACEUTICAL; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; DICARBOXYLIC ACIDS; DRUG STABILITY; HALF-LIFE; HYDROGEN-ION CONCENTRATION; KINETICS; OXIDATION-REDUCTION; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY; SPECTROPHOTOMETRY, ULTRAVIOLET; TABLETS; TECHNOLOGY, PHARMACEUTICAL; TEMPERATURE; TIME FACTORS;

EID: 44749091602     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2008.02.017     Document Type: Article

References (17)

1. Liu K.T., Wang G.F., Wei H.L., Bao T.T., and Song Z.Y. Acta Pharm. Sin. 14 (1979) 598-604
2. Liu K.T., Wei H.L., and Song Z.Y. Acta Pharm. Sin. 17 (1982) 101-105
3. Lee H.S., Kim Y.T., Jung H.C., Yoon Y.B., Song I.S., and Kim C.Y. Korean J. Int. Med. 40 (1991) 173-178
4. Yoo H.H., Son J.H., Lee J., Kim N.S., Shin M.Y., Kang M.J., and Kim D.H. Rapid Commun. Mass Spectrom. 20 (2006) 1981-1988
5. Jeong C.K., Kim S.B., Choi S.J., Sohn D.H., Ko G.I., and Lee H.S. J. Chromatogr. B: Biomed. Appl. 738 (2000) 175-179
6. Lee Y., Shim C.K., and Chung S.J. Anal. Lett. 32 (1999) 945-954
7. Park E.J., Lee S.H., Lee M.H., Ko G., Kim J., and Sohn D.H. J. Liq. Chromatogr. Relat. Technol. 21 (1998) 1833-1843
8. Qin F., Chen X.M., Liu Y.Q., Kong L., and Zou H.F. J. Sep. Sci. 27 (2004) 1195-1201
9. Hyun M.H., Lee G.S., Han S.C., and Cho Y.J. Enantiomer 6 (2001) 313-318
10. ICH, Stability Testing of New Drug Substances and Products, International Conference on Harmonization, Geneva, October 1993.
11. M. Brezina, P. Zuman, Polarography in Medicine, Biochemistry, and Pharmacy, Interscience, New York, 1958, p. 731.
12. Juan J.B.N., Carmen G.C., Maria J.V.L., and Virginia R.R. J. Chromatogr. A 1072 (2005) 249-257
13. Draper N.R., and Smith H. Applied Regression Analysis (1981), Wiley, New York pp. 22-40
14. The European Agency for the Evaluation of Medical Products. ICH Topic Q 2B Note for Guidance on Validation of Analytical Procedures: Methodology CPMP/ICH/281/95, 1996.
15. British Pharmacopoeia the Stationery Office, London, UK, 2003.
16. The United States Pharmacopeia 30, The National Formulary 25, United States Pharmacopeial Convention, Inc., 2007, pp. 249-253.
17. Snyder L.R., Kirkland J.J., and GlaJch J.L. Practical HPLC Method Development. 2nd ed. (1997), Wiley, New York, USA pp. 253-254