Microbiological assay for the determination of cefpirome in raw material and injectable preparation
DOI:
https://doi.org/10.22456/2527-2616.84473Keywords:
Cefpirome, Microbiological Assay, Cephalosporin, Cylinder-plate method, Raw Material, Injectable Preparation, Pharmaceutical dosage form, Method Validation, Quality ControlAbstract
Cefpirome is a fourth-generation cephalosporin active against a broad spectrum of gram-negative and gram-positive bacterial infections. The present work describe the development and validation of a simple, sensitive and specific agar diffusion bioassay applying cylinder-plate method for quantification of cefpirome in raw material and powder for injectable preparation. The validation method yielded good results and included linearity, precision, accuracy and specificity. The assay is based on the inhibitory effect of cefpirome upon the strain of Kocuria rizophila ATCC 9341 as the test microorganism. The result of assay were treated statistically by ANOVA and the response graphs for standard and sample solutions were linear (r = 0.9948) in the range of 0.3 – 1.2 µg mL-1, precise (intra-assay: RSD = 0.11; inter-assay: RSD = 0.18) and accurate (mean recovery value = 99.41%). A preliminary stability study of cefpirome showed that the microbiological assay is specific for the determination cefpirome in the presence of its degradation products. The proposed microbiological method allows the quantitation of cefpirome in pharmaceutical dosage form and raw material and can be used for the drug analysis in routine quality control.
Downloads
References
L.G. Martínez, P.C. Falcó, A.S. Cabeza. Comparison of several methods used for the determination of cephalosporins. Analysis of cephalexin in pharmaceutical samples. J. Pharm. Biomed. Anal. 2002; 29: 405-423.. DOI: https://doi.org/10.1016/S0731-7085(02)00089-4
H. Tumah. Fourth-generation cephalosporins: in vitro activity against nosocomial gramnegative bacilli compared with beta-lactam antibiotics and ciprofloxacin. Chemotherapy 2005; 51(2-3): 80-85. DOI: https://doi.org/10.1159/000085614
The Merck Index Online. Available from: URL: https://www.rsc.org/Merck-Index/
L.R. Wiseman, H.M. Lamb. Cefpirome. A review of its antibacterial activity, pharmacokinetic properties and clinical efficacy in the treatment of severe nosocomial infections and febrile neutropenia. Drugs 1997; 54(1):117-140. H.N. Tumah. In vitro activity of cefepime and cefpirome compared to other third-generation cephem antibiotics against gram-negative nosocomial pathogens. Pharmazie 2004; 59(11): 854-858. DOI: https://doi.org/10.2165/00003495-199754010-00013
J.F. Roos, J. Lipman, C.M. Kirkpatrick. Population pharmacokinetics and pharmacodynamics of cefpirome in critically ill patients against Gram-negative bacteria. Intensive Care Med. 2007; 33: 781-788. DOI: https://doi.org/10.1007/s00134-007-0573-7
U. Hollenstein, M. Brumnner, B. Mayer, S. Delacher, B. Erovic, H.G. Eichler, M. Müller. Target site concentrations after continuous infusion and bolus injection of cefpirome to healthy volunteers. Clin Pharmacol Ther. 2000; 67(3): 229-236. DOI: https://doi.org/10.1067/mcp.2000.104266
C. Joukhadar, N. Klein, B.X. Mayer, N. Kreischitz, G. Delle-Karth, P. Palkovits, G. Heinz, M. Muller. Plasma and tissue pharmacokinetics of cefpirome in patients with sepsis. Crit. Care Med. 30(7) (2002) 1478-1482. DOI: https://doi.org/10.1097/00003246-200207000-00013
G. MLynarczyk, A. MLynarczyk, A. Bilewska, A. Dukaczewska, C. Golawski, A. Kicman, J. Pupek, I. Serafin, M. Luczak. High effectiveness of the method with cefpirome in detection of extended-spectrum beta-lactamases in different species of gramnegative bacilli. Med Dosw Mikrobiol, 2006; 58(1): 59-65..
Y. Mrestani, A. Hartl, R.H. Neubert. Influence of absorption enhancers on the pharmacokinetic properties of non-oral betalactam-cefpirom using the rabbit (Chinchilla) in vivo model. Int. J. Pharm. 2006; 309(1-2): 67-70. DOI: https://doi.org/10.1016/j.ijpharm.2005.11.017
N. Rajput, V.K. Dumka, H.S. Sandhu. Disposition kinetics and urinary excretion of cefpirome after intravenous injection in buffalo calves. J. Vet. Sci. 2007; 8(1): 21-25. DOI: https://doi.org/10.4142/jvs.2007.8.1.21
M. Nikolovski, I.U. Kotsev, P. Panchev. Treatment with cefrom (cefpirom) in severe urological infections. Khirurgiia (Sofiia) 2004; 60(4-5): 39-41.
Rajeev Jain V. Voltammetric determination of cefpirome at multiwalled carbon nanotube modified glassy carbon sensor based electrode in bulk form and pharmaceutical formulation. Colloids Surf B Biointerfaces 2011; 87(2): 423-6. DOI: https://doi.org/10.1016/j.colsurfb.2011.06.001
Rao KS, Kumar KN, Joydeep D. New Stability Indicating RP-HPLC Method for the Estimation of Cefpirome Sulphate in Bulk and Pharmaceutical Dosage Forms. Sci Pharm. (2011); 79(4): 899-907. DOI: https://doi.org/10.3797/scipharm.1104-25
Zalewski P, Skibiński R, Cielecka-Piontek J, Bednarek-Rajewska K. Development and validation of stability-indicating HPLC method for determination of cefpiromesulfate. Acta Pol Pharm. (2014); 71(5): 731-6.
D.C. Grove, W.A. RANDALL, Assay Methods of Antibiotics. A Laboratory Manual, Medial Encyclopedia Inc., New York, NY; 1955, pp. 50-52
FARMACOPÉIA BRASILEIRA. Agencia Nacional de Vigilância Sanitária. 5. ed. Brasília; 2010.
European Pharmacopoeia, 9th ed, Council of Europe, Strasburg; 2018.
The United States Pharmacopeia 41th ed. Rochville: United States Pharmacopoeial Convention; 2018.
H. Hewitt, Microbiological assay: An introduction to quantitative principles and evaluation, New York: Academic Press 1977. DOI: https://doi.org/10.1016/B978-0-12-346450-7.50005-9
Validation on Analytical Procedures: Text and Methodology Q2(R1). In: ICH Harmonised Tripartite Guideline. International Conference on Harmonisation of Technical Requirements for registration of Pharmaceuticals for Human Use 2005.
AOAC, Official Methods of Analytical Chemists of AOAC, 15th ed. XVII 1990.
Márcia C.N. Costa, Amanda T. barden, Juliana M.M. Andrade, Tércio P. Oppe, Elfrides E.S. Schapoval. Quantitative evaluation of besifloxacin ophthalmic suspension by HPLC, application to bioassay method and cytotoxicity studies. Talanta 2014; 119: 367-374. DOI: https://doi.org/10.1016/j.talanta.2013.10.051
L.C. Vaucher, A.R. Breier, E.E.S.Schapoval, Microbiological Assay for the Determination of Telithromycin in Tables, J. AOAC Inter. (2006); 89(5): 1398-1402. DOI: https://doi.org/10.1093/jaoac/89.5.1398
BRITISH Pharmacopoeia. 2018 London: The Stationery Office; 2018.
J. Ermer, Validation in pharmaceutical analysis. Part I: An integrated approach, J. Pharmac. Biom. Anal. 2001; 24: 755-767. DOI: https://doi.org/10.1016/S0731-7085(00)00530-6
Downloads
Published
Versions
- 11-03-2026 (3)
- 08-03-2026 (2)
- 14-09-2018 (1)
How to Cite
Issue
Section
License
Copyright (c) 2018 Drug Analytical Research
This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.
The Copyright holder of manuscripts published is Drug Analytical Research. Authors who publish with this journal are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgement of its initial publication in this journal.
Licensing:
Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License
Users are allowed to read, download, copy, distribute, print, search, or link to the full texts of the articles, or use them for any other lawful purpose, without asking prior permission from the publisher or the author.
