Micellar liquid chromatographic method for the simultaneous determination of Levofloxacin and Ambroxol in combined tablets: Application to biological fluids

Abstract

BackgroundLevofloxacin hemihydrate (LEV) and ambroxol HCl (AMB) are available for the treatment of upper and lower respiratory tract infections. A survey of the literature reveals that two reversed phase HPLC methods were e reported for the simultaneous determination of LEV and AMB in pharmaceutical preparations. However the reported methods suffers from the low sensitivity, no application of the method in the combined tablets and no application to biological fluids. Also the toxic effects of the used solvents which are harmful to human beings. For this reason, our target was to develop a simple sensitive, less hazardous micellar HPLC method for the simultaneous determination of LEV and AMB in their combined dosage forms and plasma.ResultsThe method showed good linearity over the ranges of 1–44 μg/mL and 1–20 μg/mL with limits of detection 0.26 and 0.07 μg/mL and limits of quantification 0.80 and 0.20 μg/mL for LEV and AMB, respectively. The method was further extended to the determination of LEV in spiked human plasma with mean percentage recoveries of 100.10% ± 1.14 as well as determination of LEV in real human plasma without prior extraction. Statistical evaluation of the data was performed according to ICH Guidelines.ConclusionThe suggested method was successfully applied for the simultaneous analysis of the studied drugs in their co-formulated tablets and human plasma. The mean percentage recoveries in combined tablets were 100.20 ± 1.64 and 100.72 ± 1.11 for LEV and AMB, respectively and 100.10 ± 1.14 for LEV in spiked human plasma. Statistical comparison of the results with those of the comparison method revealed good agreement and proved that there were no significant difference in the accuracy and precision between the two methods respectively.

Analytical methods for the determination of certain antibiotics used in critically ill patients

“…Belal et al, presented micellar HPLC method for the simultaneous determination of Levofloxacin and ambroxol in their combined dosage forms and plasma using C18 column (150 mm × 4.6 mm i.d., 5 µm) and mobile phase composed of 0.15 M sodium dodecyl sulfate, 8% n-propanol, 0.3% triethyl amine, prepared in 0.02 M orthophosphoric acid adjusted at pH 4.0 utilizing orthophosphoric acid and the flow rate was at 1 mL/min. The column was operated at ambient temperature and the wavelength was measured at 220 nm [54] .…”

Utility of micellar liquid chromatography as an analytical tool for the estimation of three binary antibiotic mixtures. Application to biological fluids

“…Different separation techniques were reported for the estimation of the studied pharmaceuticals whether alone or combined with other pharmaceuticals. The most recent methods include HPLC [4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20], HPTLC [21,22] and capillary electrophoresis [23][24][25][26].…”

“…It is to be mentioned that the method has a short chromatographic run, which helps in assaying multiple samples. Routine-one factor at a time-steps for optimization of the developed MLC were followed and the research article concerned with MLC separation of ambroxol and levofloxacin [36] was used as a guide during experimental studies.…”

Micellar high performance liquid chromatographic determination of flunixin meglumine in bulk, pharmaceutical dosage forms, bovine liver and kidney

“…Micellar mobile phases usually need less quantity of organic modifier and generate less amount of toxic waste in comparison to aqueous-organic solvents, so that they are less toxic, non-inflammable, biodegradable and relatively inexpensive [18]. MLC has proved to be a useful technique in the determination of diverse [19][20][21][22][23][24], including food samples [25][26][27][28].…”