Abstract
A simple reversed phase HPLC method was developed and validated for the simultaneous determination of sparfloxacin (SPFX), diclofenac sodium, meloxicam, ibuprofen, flurbiprofen, naproxen and mefenemic acid in a relatively short time with high linearity in bulk material, pharmaceutical formulations and human serum. Purospher STAR C18 (250 × 4.6 mm, 5 μm) column was utilized with mobile phase, methanol and water (90:10, v/v pH 2.70 adjusted by phosphoric acid), was delivered at a flow rate of 1.5 mL.min–1. Eluent was monitored using UV detector at 240 nm. The proposed method is specific, accurate (98.42% - 102.75%), precise (intra-day and inter-day variation 0.011% - 1.85%) and linear (R2 > 0.999) with in the desired range 0.15 - 40 μg.mL–1 and the detection and quantification limit was 1.19E+08 – 0.150 μg.mL–1 and 3.62E+08 – 0.4574 μg.mL–1 respectively for SPFX and NSAIDs. The analysis of variance (ANOVA) and student’s t-test were applied to verify the results. The anticipated method is applicable to routine analysis of SPFX and NSAIDs in pharmaceutical formulations as well as in human serum samples. It has also applied on interaction of SPFX with NSAIDs.
Highlights
Sparfloxacin or cis-5-amino-1-cyclopropyl-7-(3,5-dimethylpiperazin-1-yl)-6,8-difluoro-1,4-dihydro-4-oxoquinol ine-3-carboxylic acid (SPFX) (Figure 1) is an orally active synthetically broad spectrum third generation quinolone, characterized by good to excellent activity against Gram positive cocci and in selected agent activity against anaerobes and atypical pathogens
To investigate the appropriate wavelength for simultaneous determination of sparfloxacin and all the NSAIDs, solutions of these compounds in the mobile phase were scanned by UV-visible spectrophotometer in the range 200 - 400 nm
Sparfloxacin and the reacting drugs were analyzed by measuring the area under curve (AUC), % recovery and considerable drift in retention time
Summary
Sparfloxacin or cis-5-amino-1-cyclopropyl-7-(3,5-dimethylpiperazin-1-yl)-6,8-difluoro-1,4-dihydro-4-oxoquinol ine-3-carboxylic acid (SPFX) (Figure 1) is an orally active synthetically broad spectrum third generation quinolone, characterized by good to excellent activity against Gram positive cocci (notably S. pneumoniae) and in selected agent activity against anaerobes and atypical pathogens. It is moderately active against some (B. fragilis group) L. mono-cytogenes resistant [1,2,3,4,5,6,7,8,9] and has been shown to have excellent activity, against Neisseria gonorrhoeae, and against Chlamydia trachomatis, Mycoplasmas and Gardnerella vaginalis [10]
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