HPLC与UV-VIS法测定骨修复材料复合纳米微球中左氧氟沙星的比较  

Comparison of bone repair materials composite nanospheres levofloxacin by HPLC with UV-VIS method

作　　者：王琦[1] 陈诚[1] 何小强[1] 黄伟[1] 

机构地区：[1]重庆医科大学附属第一医院骨科,重庆400016

出　　处：《生物骨科材料与临床研究》2016年第6期33-36,I0006,共5页Orthopaedic Biomechanics Materials and Clinical Study

基　　金：国家高技术研究发展计划(863计划)资助项目(编号:2013AA032203);重庆市研究生科研创新基金资助项目(编号:CYS14121)

摘　　要：目的比较高效液相色谱法（High performance liquid chromatography,HPLC）与紫外一可见分光光度计法（Ultraviolet-visible spectroscopy,UVoVIS）检测纳米微球中的左氧氟沙星，为评价可控降解骨修复材料中的药物缓释提供方法学。方法直接测定标准品左氧氟沙星，绘制两种方法的标准曲线，线性范围内选低、中、高3个浓度，计算回收率。将10个载药骨修复材料（10mm×6mm×6mm）分别浸泡于3mL模拟体液中，1天后取样，经两种方法检测，配对t检验，比较两种方法测得的结果有无统计学差异。结果HPLC法的线性回归方程：Y=O．0334X-0．叭（r==0．9996），线性范围：（0．5～250）pg／mL。UV-VIS法的线性回归方程为：Y=0．06588X＋0．01669（r==0．9999），线性范围：（0．5～50）μg／mL。HPLC法在低、中、高浓度的回收率分别为：（96．33＋0．58）％、（111．00±0．00）％、（105．00±0．00）％，RSD分别为0．37％、0．17％、0．06％；UV-VIS法的回收率分别为：（96．00±2．00）％、（99．00±0．00）％、（98．66±0．00）％，RSD分别为1．34％、0．00％、0．03％。HPLC法测得的平均浓度为：（30．43±10．27）μg／mL；UV-VIS法测得的平均浓度为：（187．93±33．52）μg／mL。两种方法测得的结果有显著统计学差异（t=20．169，P=0．000）。结论HPLC法专属性强、回收率高、精确度高，是评价纳米微球载左氧氟沙星可控降解骨修复材料中药物缓释的理想方法。Objective Comparison of high performance liquid chromatography （HPLC） with UV-visible spectropho- tometer （UV-VIS） detect levofloxacin in nanoparticles. To establish a methodology for the evaluation of drug release from the bone repair material. Methods We use different concentrations of standard levofloxacin to establish a standard curve. Choose low, medium, high concentrations within the linear range, then calculate the recovery rate. A total of 10 drug-loaded bone repair material （10mm×6mm×6mm） were immersed in 3mL SBFIndividually. All the materials were carried out for testing. The paired t-test was used to see if there are significant differences between the two results. Results The linear equations by HPLC method was： Y=0.0334X-0.01 （r= 0.9996）, The calibration curve showed linearity over a concentration range from 0.5 to 250μg/3mL; The linear equations by UV-VIS method was： Y=0.06588X＋0.01669 （r=0.9999）, The calibration curve showed linearity over a concentration range from 0.5 to 50 μg/3mL. Three different concentrations of sample recoveries by HPLC were （96.33±0.58） %, （111.00±0.00） %, （105.00±0.00） %, relative standard deviation were 0.37%, 0.17%, 0.06%; Three different concentrations of sample recoveries by UV-VIS were （96.00±2.00） %, （99.00±0.00） %, （98.66±0.00） %, relative standard deviation were 1.34%, 0.00%, 0.03%. The average concentration of HPLC method was （30.43±10.27） μg/mL; The average concentration of UV-VIS method was （187.93±33.52） /ag/mL. There was significant statistical difference between the results obtained by the two methods （t=20.169, P=0.000）. Conclusion HPLC method was found to be specific, high recovery rate, high accuracy, HPLC method was an ideal method for the evaluation of drug release from the bone repair material.

关 键 词：左氧氟沙星 骨修复材料 纳米微球 高效液相色谱法 紫外可见分光光度计法 

分 类 号：R318.08[医药卫生—生物医学工程] R68[医药卫生—基础医学]