Development and validation of a microbiological agar assay for determination of cefuroxime sodium in pharmaceutical preparations

Journal of Microbiological Methods

Volumn 77, Issue 3, 2009, Pages 308-315

  Schmidt, Cleber A ^a   Agarrayua, Danielle A ^b   Laporta, Luciane V ^b   Machado, Jaison C ^b   Manfio, Maria L ^b   Bittencourt, Celso F ^c  

^a UNIVERSITY OF FREIBURG   (Germany)

^b CENTRO UNIVERSITÁRIO FRANCISCANO   (Brazil)

^c INSTITUTO NACIONAL DE METROLOGIA   (Brazil)

Author keywords

Agar diffusion assay; Antibiotics; Cefuroxime sodium; Microbiological assay; Quality control; Validation

Indexed keywords

CEFUROXIME;

ACCURACY; AGAR DIFFUSION; ARTICLE; BACTERIAL GROWTH; BACTERIAL STRAIN; BIOASSAY; CHROMATOGRAPHY; CONTROLLED STUDY; DRUG STRUCTURE; NONHUMAN; PHYSICAL CHEMISTRY; PRIORITY JOURNAL; STAPHYLOCOCCUS AUREUS; TEMPERATURE SENSITIVITY; VALIDATION STUDY;

AGAR; ANTI-BACTERIAL AGENTS; CEFUROXIME; MICROBIAL SENSITIVITY TESTS; MICROBIOLOGICAL TECHNIQUES; PHARMACEUTICAL PREPARATIONS; STAPHYLOCOCCUS AUREUS;

STAPHYLOCOCCUS AUREUS;

EID: 67349265777     PISSN: 01677012     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.mimet.2009.03.012     Document Type: Article

References (43)

1. Ayad M.M., Shalaby A.A., Abdellatef H.E., and Elsaid H.M. Spectrophotometric and atomic absorption spectrometric determination of certain cephalosporins. J. Pharm. Biomed. Anal. 18 (1999) 975-983
2. Ayad M.M., Shalaby A.A., Abdellatef H.E., and Elsaid H.M. Spectrophotometric determination of certain cephalosporins through oxidation with cerium (IV) and 1-chlorobenzotriazole. J. Pharm. Biomed. Anal. 20 (1999) 557-564
3. Al-Momani I.F. Spectrophotometric determination of selected cephalosporins in drug formulations using flow injection analysis. J. Pharm. Biomed. Anal. 25 (2001) 751-757
4. Amin A.S., and Ragabb G.H. Spectrophotometric determination of certain cephalosporins in pure form and in pharmaceutical formulations. Spectrochim. Acta, A. 60 (2004) 2831-2835
5. Arcelloni C., Vaiani V., and Paroni R. Is the direct quantitation of antibiotics in agar by high-performance liquid chromatography useful?. J. Chromatogr. A. 812 (1998) 111-116
6. Bompadre S., Ferrante L., and Leone L. On-line solid-phase extraction of cephalosporins. J. Chromatogr. A. 812 (1998) 191-196
7. British Pharmacopoeia. Her Majesty's Stationery Office, London (2009) A334-A340; A568-A570; 2385-2386
8. Bundtzen R.W., Toothaker R.D., Nielson O.S., Madsen P.O., Welling P.G., and Craig W.A. Pharmacokinetics of cefuroxime in normal and impaired renal function: comparison of high-pressure liquid chromatography and microbiological assays. Antimicrob. Agents Chemother. 19 3 (1981) 443-449
9. Casabó V.G., Nácher A., Sanjuán M.M., and Carretero R.P. Pharmacokinetic models of the saturable absorption of cefuroxime axetil and saturable elimination of cefuroxime. Eur. J. Pharm. Sci. 21 (2003) 217-223
10. Caprile K.A. The cephalosporin antimicrobial agents: a comprehensive review. J. Vet. Pharmacol. Ther. 11 (1988) 1-32
11. Coomber P.A., Jefferies J.P., and Woodford J.D. High-performance liquid chromatographic determination of cefuroxime. Analyst 107 (1982) 1451-1456
12. El-Gindy A., Walily A.F.M.E., and Bedair M.F. First-derivative spectrophotometric and LC determination of cefuroxime and cefadroxil in urine. J. Pharm. Biomed. Anal. 23 (2000) 341-352
13. El-Sooud K.A., El-Banna H.A., Hanafy M.S.M., and Goudah A. Pharmacokinetics and intramuscular bioavailability of cefuroxime sodium in goats. Res. Vet. Sci. 69 (2000) 219-224
14. El-Walily A.F.M., Gazy A.A., Belal S.F., and Khamis E.F. Quantitative determination of some thiazole cephalosporins through complexation with palladium (II) chloride. J. Pharm. Biomed. Anal. 22 (2000) 385-392
15. European Pharmacopoeia. European Directorate for the Quality of Medicines, Strasbourg Cedex, France. 5th ed (2005) 1695-1697
16. Farmacopéia Brasileira, 1988. 4th ed., Atheneu, São Paulo, SP, pp. V.5.2.17.-1 - V.5.2.17.-15.
17. Greenwood D., Pearson N.H., and O'Grady F. Cefuroxime: a new cephalosporin antibiotic with enhanced stability to enterobacterial β-lactamases. J. Antimicrob. Chemother. 2 (1976) 337-343
18. Hekster Y.A., Baars A.M., and Vree T.B. J. Antimicrob. Chemother. 6 (1980) 65-71
19. Hewitt W. Microbiological Assay for Pharmaceutical Analysis: a Rational Approach (2003), Interpharm/CRC Press, Boca Raton, FL 97-115
20. Hodjes N.A. Pharmaceutical applications of microbiological techniques. In: Aulton M.E. (Ed). Pharmaceutics: The Science of Dosage Form Design (2001), Churchill Livingstone, London 623-643
21. ICH. Harmonised tripartite guideline. validation of analytical procedures: text and methodology - Q2(R1). ICH Steering Committee (2005), Commission of the European Communities, Geneva
22. James N.C., Donn K.H., Collins J.J., Davis I.M., Lloyd T.L., Hart R., and Powell J.R. Pharmacokinetics of cefuroxime axetil and cefaclor: relationship of concentrations in serum to MICs for common respiratory pathogens. Antimicrob. Agents Chemother. 35 (1991) 1860-1863
23. Nilsson-Ehle I., and Nilsson-Ehle P. Liquid chromatographic assay of cefuroxime in serum. Clin. Chem. 24 2 (1978) 365-367
24. Mattie H., Van-Dokkum A.M., Bus-Weijer L., Krul A.M., and Vanstrijen E. Antibacterial activity of four cephalosporins in an experimental infection in relation to in vitro effect and pharmacokinetics. J. Infect. Dis. 162 (1990) 717-722
25. Murillo J.A., Lemus J.M., and Garcia L.F. Spectrofluorimetric analysis of cefuroxime in pharmaceutical dosage forms. J. Pharm. Biomed. Anal. 12 7 (1994) 875-881
26. O'Callaghan C.H., Sykes R.B., Griffiths A., and Thornton J. Cefuroxime, a new cephalosporin antibiotic: activity in vitro. Antimicrob. Agents Chemother. 9 (1976) 511-519
27. Okoye N.N., Nwokedi G.I.C., Ukwueze N.N., and Okoye F.B.C. Spectrophotometric determination of some cephalosporin antibiotics using Prussian blue reaction. Sci. Res. Essay. 2 8 (2007) 342-347
28. Pajchel G., and Tyski S. Adaptation of capillary electrophoresis to the determination of selected cephalosporins for injection. J. Chromatogr. A. 895 (2000) 27-31
29. Ródenas V., Parra A., Garcia-Villanova J., and Gomez M.D. Simultaneous determination of cefepime and L-arginine in injections by second-derivative spectrophotometry. J. Pharm. Biomed. Anal. 13 (1995) 1095-1099
30. Rodenbach M.-P., Hecq J.-D., Vanbeckbergen D., Jamart J., and Galanti L. Stability of cefuroxime infusion: the brand-name drug versus a generic product. Eur. J. Hosp. Pharm. Sci. 12 (2006) 32-34
31. Rose U. In situ degradation: a new concept for system suitability tests in monographs of the European Pharmacopoeia. J. Pharm. Biomed. Anal. 18 (1998) 1-14
32. Ryan D.M., O'Callaghan C.H., and Muggleton P.W. Cefuroxime, a new cephalosporin antibiotic: activity in vivo. Antimicrob. Agents Chemother. 9 (1976) 520-525
33. Salem H., and Askal H. Colourimetric and AAS determination of cephalosporins using Reineck's salt. J. Pharm. Biomed. Anal. 29 (2002) 347-354
34. Schmidt C.A., Carazzo M., Laporta L., Bittencourt C.F., Santos M.R., and Friedrich M. Development and validation of an agar diffusion assay for determination of ceftazidime in pharmaceutical preparations. J. AOAC Int. 91 1 (2008) 59-66
35. Shah V.P., Midha K.K., Findlay J.W.A., Hill H.M., Hulse J.D., McGilveray I.J., McKay G., Miller K.J., Patnaik R.N., Powell M.L., Tonelli A., Viswanathan C.T., and Yacobi A. Bioanalytical method validation - a revisit with a decade of progress. Pharm. Res. 17 (2000) 1551-1557
36. Sciacchitano C.J., Mopper B., and Specchio J.J. Identification and separation of five cephalosporins by micellar electrokinetic capillary chromatography. J. Chromatogr., B. 657 (1994) 395-399
37. Souza M.J., Kulmann R.R., Silva L.M., Nogueira D.R., Zimmermann E.S., and Schmidt C.A. Development and in-house validation of a microbiological assay for determination of cefepime in injectable preparations. J. AOAC Int. 89 (2006) 1367-1373
38. The Index Merck, 2001. 30th ed. Whitehouse Station: Merck Research Laboratories, Merck&CO., NJ, pp 355.
39. The Japanese Pharmacopoiea. 14th ed., 2001. Yakuji Nippo LTD, Tokyo, pp 348-349.
40. The United States Pharmacopoeia, 2008. 31st ed., Pharmacopoeial Convention Rockville, MD, pp 91-98 / 1700-1702.
41. Xerri L., Broggio R., Caro B., and Scheda P. Importance of inoculum growth phase when using an in vitro pharmacokinetic model to evaluate β-lactam antibiotics. Chemiot. Int. J. Mediterr. Soc. Chemotherapy. 7 (1988) 79-85
42. Zegota H., and Pietka M. Elimination of the toxic effects of patulin on Bacillus subtilis and B. megaterium by irradiation. Z. Lebensm.-Unters. Forsch. 188 (1989) 348
43. Zegota H., Koprowski M., and Zeggta A. Stability of cefuroxime following gamma-irradiation in the solid state. Radiat. Phys. Chem. 43 4 (1994) 343-348