Stability of cefazolin and other new cephalosporins following gamma irradiation

Jacobs, G.P.

doi:10.1016/0378-5173(83)90015-7

Cited by 24 publications

(7 citation statements)

References 4 publications

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“…Millipore Q Water was used as a reference. Sam- composition of cefazolin sodium by ionizing radiation was low and was found to be slightly higher than that measured by Jacobs (1983) [2] who concluded that ''gamma radiation only slightly reduces the potency of cefazolin''. Nevertheless, the irradiated samples met the specifications of the European Pharmacopoeia (1997) [3].…”

Section: Colour Measurementsmentioning

confidence: 93%

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Radiosensitivity study of cefazolin sodium

Crucq

Slegers

Deridder

et al. 2000

Talanta

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The extent of physico-chemical changes induced by irradiation of cefazolin sodium was investigated. The methods used were potency determination, impurity profile, colour measurements and pH measurements. The potency of irradiated samples at 25 kGy was 4 9 2% lower than that of the non irradiated ones. The total amount of related substances increased from 0.72 90.01% in the non irradiated samples to 4.9 9 0.7% in the samples irradiated at 25 kGy. Most of the peaks showed trace amounts ( B 0.01%), the largest one represented 1.2 9 0.5% of the total related substances. Only two peaks were identified by chromatography: the methyl-1,2,3-thiazol-2 thiol-5 and the 7-aminocephalosporanic acid. The latter related substance is only produced by the irradiation of cefazolin sodium. The pH values of the samples were within the specifications of the European Pharmacopoeia. The colour of the cefazolin sodium powder changed from white to yellow upon irradiation. The yellow colour persisted after the dissolution of the powder. Most of the tests carried out met the Pharmacopoeia's specifications, except the one concerning the colour of the solution.

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Section: Colour Measurementsmentioning

confidence: 93%

“…Radiation processing is clean and well controlled as described by Dam et al (1995) [1]. The only important parameter to control is the dose required to achieve sterilization, as reported by Jacobs (1983) [2].…”

Section: Introductionmentioning

confidence: 99%

Radiosensitivity study of cefazolin sodium

Crucq

Slegers

Deridder

et al. 2000

Talanta

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“…However, very few methods are available for effective assessment of the stability of cefazolin sodium. Calorimetry, 31 gamma irradiation, 32 and electrophoresis 33 can be used to indicate stability, but are not widely used, especially at an industrial level. Chromatographic methods developed by Mayer and Petsch, 21 Al-Rawithi et al, 26 Arayne et al, 35 Liang and Chow, 36 and Tsai and Chen 37 cannot assess stability.…”

Section: Resultsmentioning

confidence: 99%

“…Methods used to determine the stability of cefazolin sodium include calorimetry, gamma irradiation, and electrophoresis, [31][32][33] all of which are inferior to HPLC. Therefore, we attempted to develop a sensitive, accurate, and specific HPLC method for assessing the stability of cefazolin sodium using ultraviolet detection.…”

Section: Introductionmentioning

confidence: 99%

Novel HPLC method for quantitative determination of cefazolin sodium in pharmaceutical formulations

Hasan¹,

Sher²,

Siddiqui³

et al. 2013

RRMC

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This paper reports a validated high-performance liquid chromatography method which is rapid, highly specific, and accurate for determination of cefazolin sodium in injectable pharmaceutical formulations. Separation was carried out using a Hibar ® µBondapak ® C 18 column with a mobile phase consisting of an acetonitrile to monobasic sodium phosphate buffer ratio of 17:83 and a flow rate of 1.0 mL per minute, and monitoring at a wavelength of 254 nm. The calibration curve was linear, with a correlation coefficient .0.9995 in the range of 5-100 µg/mL. Drug recovery was 98.35%-100.86%, with a limit of detection of 12.92 ng/mL and a limit of quantification of 43.09 ng/mL. The drug was subjected to stress conditions of hydrolysis (acid, base, oxidation, and thermal degradation), where maximum degradation was observed. Forced degradation studies confirmed stability indicating power of this method, which was validated in accordance with International Conference on Harmonization guidelines and used successfully to quantify the amounts of cefazolin sodium in bulk injectable formulations and in physiological fluid.

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“…Electron spin resonance (ESR) spectroscopy appears to be well suited for determination of free radical concentrations in complex media and so, it can be used to detect and distinguish between irradiated drugs from unirradiated ones (Gibella et al, 1993;Signoretti et al, 1994;Miyazaki et al, 1994;Onori et al, 1996). As a cephalosporin antibiotic, duricef is used in the treatment of nose, throat, urinary tract and skin infection that are caused by specific bacteria, including staph strep and E. coli, effects of gamma radiation on cephalosporins with various substitutive groups have been reported in different papers (Miyazaki et al, 1994;Onori et al, 1996;Jacobs, 1983;Yũrũs and Korkmaz, 2005;Gibella et al, 2000), but low-and high-temperature kinetic features, structure and activation energies of the radical species involved in the formation of their ESR spectra were investigated in none of these papers, except of few published work (Yũrũs, S and Korkmaz, M., 2005). Eleven of the studied cephalosporins with various substitutive groups have been shown to exhibit, interestingly ESR spectra of unresolved doublet appearence (Onori et al, 1996;Yũrũs and Korkmaz, 2005).…”

Section: Drugs and Medical Products Irradiationmentioning

confidence: 99%

Ionizing Radiation Induced Radicals

Maghraby¹

2012

Current Topics in Ionizing Radiation Research

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Stability of cefazolin and other new cephalosporins following gamma irradiation

Cited by 24 publications

References 4 publications

Radiosensitivity study of cefazolin sodium

Radiosensitivity study of cefazolin sodium

Novel HPLC method for quantitative determination of cefazolin sodium in pharmaceutical formulations

Ionizing Radiation Induced Radicals

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