Non Chiral And Chiral Capillary Zone Electrophoresis Methods For The Analysis Of Fluoroquinolones And Primaquine

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Date
2008-06
Authors
Elbashir, Abdalla Ahmad
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Abstract
A capillary zone electrophoresis (CZE) method has been developed for the individual determination of the antibiotics gemifloxacin (GEM), lomefloxacin (LOM), ofloxacin (OFL) and sparfloxacin (SPAR) in tablets. The CZE separation was performed using a 75 I-Im x 35 cm fused-silica capillary under the following conditions: 25°C; applied voltage, 1 ~ kV; 25 mM H3P04-NaOH running buffer (pH 8.5). The detection wavelength was 254 nm. Flumequine was used as internal standard. The limits of detection (LODs) of GEM, LOM, OFL and SPAR were estimated to be 2.93, 3.87, 1.24 and 5.38 I-Ig mL-1 , respectively while the limit of quantitation (LOOs) were 4.91, 8.93, 4.01 and 9.46 I-Ig mL-1 , respectively. Recoveries ranging from 94.4 - 108.6% were obtained. Excipients in commercial tablets and degraded products from different stressed conditions did not interfere in the assay. The method was successfully applied to the determination of GEM, LOM, OFL and SPAR in pharmaceutical tablets. A CZE method for the separation of the enantiomers of OFL using carboxymethyl-J3-cyclodextrin (CM-J3-CD) as chiral selector is also described. The highest resolution of OFL enantiomers obtained was around 2.8. This was achieved using tris-citrate buffer (pH 4.5) that contained 3 mg mL-1 CM-J3-CD. Recoveries between 98.3-103.4 % were obtained when the method was used to determine the enantiomers of OFL that were spiked to placebos. The proposed method is fast, sensitive, inexpensive and its usefulness was demonstrated for the analysis of five pharmaceutical preparations. CZE methods have also been developed for the separation of the antimalarial drug primaquine (PO) from its impurity, the positional isomer quinocide (OC). Different buffer additives such as native cyclodextrins and crown ethers were evaluated. The use of 18C6 offers slight advantages over f3-CD such as faster migration times and improved resolution. But nevertheless, elution times of less 5 minutes and resolution of 2-4 were obtained when both additives were used. 2.12 and 2.71% (w/w) of OC were found in pharmaceutical preparations of PO from two different manufacturers. Possible mechanism that leads to the successful separation of the isomers is also discussed. CZE method for the baseline-separation of the enantiomers of PO and OC in pharmaceutical formulations is also proposed. Optimum separations of the three components were separated using 50 mM tris phosphate buffer (pH 3.0) containing 15 mM hydroxypropyl-y-cyclodextrin (HP-y-CD) as background electrolyte. Under the optimized conditions, the components were successfully separated in about 5 min. The proposed method was applied for the determination of OC impurity in PO formulations. The separation of the enantiomeric pairs of PO and those of OC was also successfully carried out using a dual chiral selector (15 mM HP-y-CD and 4 mg mL-1 sulphated-p-CD, pH 4.0), and was operated in the reversed polarity mode.
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Electrophoresis Methods , For The Analysis Of Fluoroquinolones
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