ICH guidance in practice: Validated stability-indicating HPLC method for simultaneous determination of ampicillin and cloxacillin in combination drug products

Journal of Pharmaceutical and Biomedical Analysis

Volumn 43, Issue 2, 2007, Pages 769-773

  Kumar, Vijay ^a   Bhutani, Hemant ^a   Singh, Saranjit ^a  

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

Author keywords

Ampicillin; Cloxacillin; HPLC; Stability; Validation

Indexed keywords

AMPICILLIN; ANTIBIOTIC AGENT; CLOXACILLIN;

ALKALINITY; ANALYTIC METHOD; ANTIBIOTIC THERAPY; ARTICLE; DRUG DEGRADATION; DRUG DETERMINATION; DRUG FORMULATION; DRUG HYDROLYSIS; DRUG INDUSTRY; DRUG STABILITY; FLOW RATE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; INFECTION; INTERNATIONAL CONFERENCE ON HARMONIZATION; INTERNATIONAL COOPERATION; LIQUID CHROMATOGRAPHY; NONHUMAN; OXIDATION; PRACTICE GUIDELINE; PRIORITY JOURNAL; REGRESSION ANALYSIS; SOLID STATE; UNITED KINGDOM;

ACETONITRILES; AMPICILLIN; ANTI-BACTERIAL AGENTS; BUFFERS; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; CLOXACILLIN; DRUG COMBINATIONS; DRUG STABILITY; GUIDELINES; HYDROGEN-ION CONCENTRATION; HYDROLYSIS; LINEAR MODELS; OXIDATION-REDUCTION; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY; SOLVENTS;

EID: 33845678679     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2006.07.051     Document Type: Article

References (22)

1. Singh S., Singh B., Bahuguna R., Wadhwa L., and Saxena R. J. Pharm. Biomed. Anal. 41 (2006) 1037-1040
2. Mohammadi A., Haririan I., Rezanour N., Ghiasi L., and Walker R.B. J. Chromatogr. A 1116 (2006) 153-157
3. Ivana I., Ljiljana Z., and Mira Z. J. Chromatogr. A 1119 (2006) 209-215
4. ICH, Q1A(R2) Stability testing of new drug substances and products. International Conference on Harmonization (2003), IFPMA, Geneva
5. Grosa G., Grosso E.D., Russo R., and Allegrone G. J. Pharm. Biomed. Anal. 41 (2006) 798-803
6. Mishal A., and Sober D. J. Pharm. Biomed. Anal. 39 (2005) 819-823
7. Nishida M., Mine Y., and Kuwahara S. J. Antibiot. 22 (1969) 144-150
8. Bornside G.H. App. Microbiol. 16 (1968) 1507-1511
9. Okeke I.N., Lamikanra A., and Edelmant R. Emerg. Inf. Dis. 5 (1999) 18-27
10. Haginaka J., Wakai J., Yasuda H., Uno T., Takahashi K., and Katagi T. J. Chromatogr. A 400 (1987) 101-111
11. Akhtar M.J., Khan S., and Khan M.A.S. J. Pharm. Biomed. Anal. 11 (1993) 375-378
12. Ishida M., Kobayashi K., Awata N., and Sakamoto F. J. Chromatogr. B 727 (1999) 245-248
13. Moats W.A. J. Chromatogr. A 317 (1984) 311-318
14. Perez B., Prats C., Castells E., and Arboix M. J. Chromatogr. B 698 (1997) 155-160
15. Grover M., Gulati M., and Singh S. J. Chromatogr. B 708 (1998) 153-159
16. Burns D.T., O'Callaghan M., Smyth W.F., and Ayling C.J. Anal. Bioanal. Chem. 340 (1991) 53-56
17. Sorensen L.K., Rusmussen B.M., Singh J., Boison J.O., and Keng L. J. Chromatogr. B 694 (1997) 383-391
18. Abuirjeie M.A., and Abdel-Hamid M.A. J. Clin. Pharm. Ther. 13 (1988) 101-108
19. Kumar V., Bhutani H., and Singh S. Indian Drugs 43 (2006) 376-382
20. British Pharmacopoeia (2002), British Pharmacopoeial Commission, London p 136-138
21. British Pharmacopoeia (2002), British Pharmacopoeial Commission, London p 479-481
22. ICH, Q1(B) Stability testing: Photostability testing of new drug substances and products. International Conference on Harmonization (1996), IFPMA, Geneva