Belal Fathalla F, Sharaf El-Din Mohie K, El-Enany Nahed M, Saad Samar
Department of Analytical Chemistry, Faculty of Pharmacy, University of Mansoura, Mansoura 35516, Egypt.
Chem Cent J. 2013 Oct 1;7(1):162. doi: 10.1186/1752-153X-7-162.
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.
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.
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.
左氧氟沙星半水合物（LEV）和盐酸氨溴索（AMB）可用于治疗上、下呼吸道感染。文献调查显示，已有两种反相高效液相色谱法用于同时测定药物制剂中的LEV和AMB。然而，所报道的方法灵敏度较低，未应用于复方片剂，也未应用于生物样品。此外，所用溶剂具有毒性，对人体有害。因此，我们的目标是开发一种简单、灵敏、危害较小的胶束高效液相色谱法，用于同时测定复方制剂和血浆中的LEV和AMB。
该方法在1 - 44 μg/mL和1 - 20 μg/mL范围内具有良好的线性，LEV和AMB的检测限分别为0.26和0.07 μg/mL，定量限分别为0.80和0.20 μg/mL。该方法进一步扩展到测定加标人血浆中的LEV，平均回收率为100.10% ± 1.14，以及无需预先提取直接测定实际人血浆中的LEV。数据的统计评估按照国际人用药品注册技术协调会（ICH）指南进行。
所建议的方法成功应用于同时分析复方片剂和人血浆中的受试药物。复方片剂中LEV和AMB的平均回收率分别为100.20 ± 1.64和100.72 ± 1.11，加标人血浆中LEV的平均回收率为100.10 ± 1.14。将结果与对照方法进行统计比较，结果显示良好的一致性，证明两种方法在准确度和精密度方面均无显著差异。
