Abstract
Purpose: To develop and validate a simple chromatographic method for the analysis of ciprofloxacin and moxifloxacin in human serum.Methods: After protein precipitation had been performed, high performance liquid chromatography (HPLC) with UV detection was utilized for the analysis of ciprofloxacin and moxifloxacin in human serum. Analytical column Zorbax SB-C18 (150 mm x 4.6 mm i.d., particle size 3.5 μm) was used as a stationary phase. Chromatographic separation was realized with the mobile phase 0.1% trifluoroacetic acid in water for chromatography - methanol (66:34, v/v), at the flow rate of 1 mL/min, temperature of 35 oC and detection at 280 nm. The method validation was performed according to the guidelines of the European Medicines Agency (EMA).Results: The chromatographic run time was about 12 minutes and no interference was observed. For ciprofloxacin, the method was linear over a concentration range of 0.5-50 μg/mL, with a correlation coefficient of 0.9874. For moxifloxacin, the method was linear over a concentration range of 0.5-50 μg/mL, with a correlation coefficient of 0.9946. Since relative standard deviation (RSD) and relative recovery values were within acceptable limits according to EMA guidelines, good intra-day precision, inter-day precision, as well as the accuracy of the method, were observed.Conclusion: A simple and reliable HPLC-UV method has been developed and validated for the simultaneous determination of ciprofloxacin and moxifloxacin in human serum. The method can be applied for therapeutic drug monitoring but also and pharmacokinetic studies of ciprofloxacin and moxifloxacin.
 Keywords: Human serum, Ciprofloxacin, Moxifloxacin, Protein precipitation, HPLC, UV detection, Method validation
Highlights
Ciprofloxacin (CIP) and moxifloxacin (MOX) belong to fluoroquinolones, a class of broadspectrum antibiotics affecting both Gram-positive and Gram-negative bacteria [1]
CIP and MOX are both recommended in the treatment of community-acquired pneumonia and as second-line agents for multidrug-resistant tuberculosis [2,4,5,6]
Co-elution was not observed at the retention times of CIP, MOX and Internal standard methylparaben (IS) [14]
Summary
Ciprofloxacin (CIP) and moxifloxacin (MOX) belong to fluoroquinolones, a class of broadspectrum antibiotics affecting both Gram-positive and Gram-negative bacteria [1]. CIP is a fluoroquinolone with notable antimicrobial activity against Pseudomonas species, Enterobacteriaceae strains resistant to gentamicin, as well as methicillin-resistant Staphylococcus aureus strains. Moxifloxacin (MOX), a fourth-generation fluoroquinolone, has a prolonged effect on Grampositive pathogens, including Streptococcus pneumoniae, atypical organisms and anaerobes. This so-called, “respiratory quinolone” is used in the eradication of Helicobacter pylori. All standard stock and working solutions of CIP and MOX were prepared fresh every day [14]. Afterwards, each of the seven tubes received one of the following volumes 0.15, 0.45, 1.5, 4.5, 7.5, 13.5 and 15 μL of 1 mg/mL CIP and MOX standard working solutions. The following validation characteristics were considered: selectivity, linearity, sensitivity, accuracy, precision, absolute recovery and stability of the analytes [14]
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