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

Chemistry Central Journal

Fathalla F Belal¹  Mohie K Sharaf El-Din¹  Nahed M El-Enany¹  Samar Saad¹ 

[1] Department of Analytical Chemistry, Faculty of Pharmacy, University of Mansoura, Mansoura 35516, Egypt

关键词: Human plasma;    Co-formulated tablets;    Levofloxacin (LEV) Ambroxol (AMB);    Simultaneous determination;    Micellar;    HPLC;   

Others  :  787832
DOI  :  10.1186/1752-153X-7-162

 received in 2013-04-26, accepted in 2013-08-30,  发布年份 2013

【 摘 要 】

Background

Levofloxacin 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.

Results

The 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.

Conclusion

The 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.

【 授权许可】

   
2013 Belal et al.; licensee Chemistry Central Ltd.

【 图 表 】

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