高效液相色谱法测定复方阿莫西林舒巴坦钠纳米乳含量

摘要

[目的]建立了高效液相色谱（HPLC）法测定复方阿莫西林舒巴坦钠纳米乳含量的分析方法。[方法]采用HPLC法测定复方阿莫西林舒巴坦钠纳米乳含量。色谱柱为Diamond C18柱（250 mm×4.6 mm，5μm），流动相为磷酸盐缓冲液-乙腈-水，检测波长为220 nm。[结果]阿莫西林在40～400μg/mL的范围内，线性关系良好（r=0.9990），回收率为99.9%，RSD为0.52%。舒巴坦钠在20～200μg/mL的范围内，线性关系良好（r=0.9998），回收率为99.9%，RSD为0.66%。[结论]该方法为控制复方阿莫西林舒巴坦钠纳米乳质量提供了可靠的定量分析方法。%[Objective] The aim was to establish an HPLC method for assay detection of compound amoxicillin & sulbactam sodium nanoemulsion. [Method] An HPLC system was equipped with a Diamond C18 (250 mm ×4.6 mm,5 μm),using acetonitrile - water -phosphate buffer as mobile phase, and the detective wavelength was 220 nm. [Result] The amoxicillin within 40-400μg/mL had good linear relation (r=0.999 0);the average recovery was 99.9%;the RSD was 0.52%. The sulbactam sodium within 20-200 μg/mL had good linear relation (r=0.999 8); the average recovery was 99.9%; the RSD was 0.66%. [Conclusion] This method provides reliable quantitative analysis method for controlling quality of compound amoxicillin &sulbactam sodium nanoemulsion.