ICH guidance in practice: Stress degradation studies on metronidazole and development of a validated stability-indicating HPLC assay method

Pharmaceutical Technology

Volumn 27, Issue 10, 2003, Pages 148-156

  Bakshi, Monika ^a   Singh, Saranjit ^a  

^a NATIONAL INSTITUTE OF PHARMACEUTICAL EDUCATION AND RESEARCH NIPER   (India)

Author keywords

[No Author keywords available]

Indexed keywords

ASSAYS; DEGRADATION; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HYDROLYSIS; OXIDATION; PHOTOLYSIS; PYROLYSIS; STRESSES;

METRONIDAZOLE; SPECIFICITY; STRESS DEGRADATION; STRESS-TESTING CONDITIONS;

DRUG PRODUCTS;

METRONIDAZOLE;

ACCURACY; ANALYTIC METHOD; DEGRADATION; DRUG PURITY; DRUG QUALITY; DRUG STABILITY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMIDITY; HYDROLYSIS; INTERMETHOD COMPARISON; OXIDATION; PHOTOLYSIS; PRACTICE GUIDELINE; REVIEW; TEMPERATURE SENSITIVITY; VALIDATION PROCESS;

EID: 7944224312     PISSN: 15432521     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (6)

1. ICH, Stability Testing of New Drug Substances and Products (International Conference on Harmonization, IFPMA, Geneva, 2000).
2. Martindale: The Complete Drug Reference, S.C. Sweetman, Ed. (Pharmaceutical Press, London, Chicago, 2002), pp. 594-597.
3. S.K. Baveja and H.K. Khosla, "Decomposition of Metronidazole in Aqueous Solutions," Indian J. Technol. 13, 528 (1975).
4. E.I. A/Karim, K.E. Ibrahim, and M.E. Adam, "Studies on the Photochemical Decomposition of Metronidazole," Int. J. Pharm. 76, 261-264 (1991).
5. A.R. Barnes and J.K. Sugden, "Assay of Photolysed Metronidazole Solution," J. Pharm. Pharmacol. 37 (supplement), 10P (1985).
6. R. Godfrey and R. Edwards, "A Chromatographic and Spectroscopic Study of Photodegraded Metronidazole in Aqueous Solution," J. Pharm. Sci. 80, 212-218 (1991).