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A degradation study of cefepime hydrochloride in solutions under various stress conditions by TLC-densitometry.
Biomed Chromatogr 2015; 29(3):388-95BC

Abstract

A rapid, accurate and sensitive thin-layer chromatography (TLC) method with densitometric detection has been developed and validated for the determination of cefepime in pharmaceuticals. Chromatographic separation was achieved on a silica gel TLC F254 plates with a mobile phase consisting of ethanol-2-propanol-glacial acetic acid 99.5%-water (4:4:1:3, v/v). Densitometric detection was carried out at wavelength of 266 nm in reflectance/absorbance mode. The validation of the method was found to be satisfactory with high accuracy (from 99.24 to 101.37%) and precision (RSD from 0.06 to 0.36%). Additionally, the stability of cefepime in solution was investigated, including the effect of pH, temperature and incubation time. Favorable retention parameters (Rf , Rs, α) were obtained under the developed conditions, which guaranteed good separation of the studied components. The degradation process of cefepime hydrochloride was described by kinetic and thermodynamic parameters (k, t0.1 , t0.5 and Ea). Moreover, the chemical properties of degradation products were characterized by the Rf values, absorption spectra, HPLC-MS/MS and TLC-densitometry analysis. As the method could effectively separate the active substance from its main degradation product (1-methylpyrrolidine), it can be employed as a method to indicate the stability of this drug.

Authors+Show Affiliations

Department of Inorganic and Analytical Chemistry, Faculty of Pharmacy, Collegium Medicum, Jagiellonian University, 9 Medyczna Str, 30-688, Kraków, Poland.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

25042047

Citation

Dąbrowska, Monika, et al. "A Degradation Study of Cefepime Hydrochloride in Solutions Under Various Stress Conditions By TLC-densitometry." Biomedical Chromatography : BMC, vol. 29, no. 3, 2015, pp. 388-95.
Dąbrowska M, Starek M, Krzek J, et al. A degradation study of cefepime hydrochloride in solutions under various stress conditions by TLC-densitometry. Biomed Chromatogr. 2015;29(3):388-95.
Dąbrowska, M., Starek, M., Krzek, J., Papp, E., & Król, P. (2015). A degradation study of cefepime hydrochloride in solutions under various stress conditions by TLC-densitometry. Biomedical Chromatography : BMC, 29(3), pp. 388-95. doi:10.1002/bmc.3288.
Dąbrowska M, et al. A Degradation Study of Cefepime Hydrochloride in Solutions Under Various Stress Conditions By TLC-densitometry. Biomed Chromatogr. 2015;29(3):388-95. PubMed PMID: 25042047.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A degradation study of cefepime hydrochloride in solutions under various stress conditions by TLC-densitometry. AU - Dąbrowska,Monika, AU - Starek,Małgorzata, AU - Krzek,Jan, AU - Papp,Elżbieta, AU - Król,Piotr, Y1 - 2014/07/07/ PY - 2014/03/10/received PY - 2014/04/29/revised PY - 2014/06/06/accepted PY - 2014/7/22/entrez PY - 2014/7/22/pubmed PY - 2015/9/29/medline KW - cefepime hydrochloride KW - degradation process KW - densitometric detection KW - thin-layer chromatography SP - 388 EP - 95 JF - Biomedical chromatography : BMC JO - Biomed. Chromatogr. VL - 29 IS - 3 N2 - A rapid, accurate and sensitive thin-layer chromatography (TLC) method with densitometric detection has been developed and validated for the determination of cefepime in pharmaceuticals. Chromatographic separation was achieved on a silica gel TLC F254 plates with a mobile phase consisting of ethanol-2-propanol-glacial acetic acid 99.5%-water (4:4:1:3, v/v). Densitometric detection was carried out at wavelength of 266 nm in reflectance/absorbance mode. The validation of the method was found to be satisfactory with high accuracy (from 99.24 to 101.37%) and precision (RSD from 0.06 to 0.36%). Additionally, the stability of cefepime in solution was investigated, including the effect of pH, temperature and incubation time. Favorable retention parameters (Rf , Rs, α) were obtained under the developed conditions, which guaranteed good separation of the studied components. The degradation process of cefepime hydrochloride was described by kinetic and thermodynamic parameters (k, t0.1 , t0.5 and Ea). Moreover, the chemical properties of degradation products were characterized by the Rf values, absorption spectra, HPLC-MS/MS and TLC-densitometry analysis. As the method could effectively separate the active substance from its main degradation product (1-methylpyrrolidine), it can be employed as a method to indicate the stability of this drug. SN - 1099-0801 UR - https://www.unboundmedicine.com/medline/citation/25042047/A_degradation_study_of_cefepime_hydrochloride_in_solutions_under_various_stress_conditions_by_TLC_densitometry_ L2 - https://doi.org/10.1002/bmc.3288 DB - PRIME DP - Unbound Medicine ER -