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Acta Veterinaria Hungarica
Authors: Duygu Durna Corum, Orhan Corum, Ramazan Yildiz, Hatice Eser Faki, Merve Ider, Gul Cetin and Kamil Uney

be used at an appropriate dosage regimen in target species to prevent the development of resistance to fluoroquinolone antibiotics and ensure their safe use in both humans and animals ( WHO, 1998 ; CVMP, 2007 ). Levofloxacin, a levo isomer of

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-07-6), cephalexin·H 2 O (CAS No. 23325-78-2), ciprofloxacin HCl (CAS No. 86393-32-0), levofloxacin (CAS No. 100986-85-4), and metronidazole (CAS No. 443-48-1). All of these compounds are antimicrobial pharmaceuticals. In addition, ciprofloxacin HCl and levofloxacin

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Summary

The objective of the current study is to develop a validated specific stability-indicating isocratic reversed-phase liquid chromatographic method for the quantitative determination of levofloxacin and its related substances in pharmaceutical dosage forms in the presence of degradation products and its process-related impurities. Forced degradation studies were performed on levofloxacin as per the International Conference on Harmonisation (ICH)-prescribed stress conditions using acid, base, oxidative, water hydrolysis, thermal stress and photolytic degradation to show the stability-indicating power of the method. Significant degradation was observed during oxidative stress; minor degradation was observed in acidic stress and no degradation was observed in other stress conditions. The chromatographic method was optimized using the samples generated from forced degradation studies and the spiked impurity solution. The analysis was carried out with a 50 mm length × 4.6 mm i.d., 3.0 μm particle size YMC Pack Pro-C18 column using the mobile phase consisting of a mixture of 1.0% (v/v) triethylamine in water with pH adjusted to 6.30, using orthophosphoric acid, methanol and acetonitrile (7.7:1.3:1.0) pumped at a flow rate of 0.8 mL min−1 with ultraviolet (UV) detection at 235 nm. The limit of detection and the limit of quantification for the levofloxacin and its process-related impurities were established. The stressed test solutions were assayed against the qualified working standard of levofloxacin and the mass balance in each case was in between 99.1% and 99.9%, indicating that the developed liquid chromatography (LC) method was a stability-indicating technique. Validation of the developed LC method was carried out as per ICH requirements.

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sulfamethoxazole/trimethoprim (or co-trimoxazole; 15 mg kg −1 day −1 ) [ 12, 14 ]. Additionally, a recent meta-analysis has concluded that the use of levofloxacin in these infections is non-inferior to sulfamethoxazole/trimethoprim [ 20 ]. Nonetheless, in certain

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, ertapenem, nitrofurantoin, ampicillin, cefazolin, amoxicillin/clavulanic acid, ampicillin/sulbactam, ceftriaxone, ceftazidime, piperacillin/tazobactam, cefepime, ciprofloxacin, levofloxacin, gentamicin, tobramycin, and trimethoprim/sulfamethoxazole using AST

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. 2007 59 874 879 Lee, C. C., Lee, V. W., Chan, F. K. és mtsa: Levofloxacin-resistant Helicobacter

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collected. Species identification was done by MALDI-TOF/MS (Bruker Daltonik GmbH, Bremen, Germany). Antibiotic susceptibility MIC values of nalidixic acid, ciprofloxacin, levofloxacin, and moxifloxacin were determined by

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Li, Y., Huang, X., Xao, L. és mtsai: Advantages of moxifloxacin and levofloxacin-based triple therapy for second-line treatments of persistent Helicobacter pylori infection, a meta-analysis. Wien. Klin. Wschr., 2010, 122 , 413

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Karczewska, E., Wojtas-Bonior, I., Sito, E., et al.: Primary and secondary chlarithromycin, metronidazole, amoxicillin and levofloxacin resistance to Helicobacter pylori in southern Poland. Pharmacol. Rep., 2011, 63 , 799

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