HPLC-DAD法测定康复新液中10种抑菌剂含量  

Determination of ten bacteriostatic agents in Kangfuxin Solution by HPLC-DAD method

作　　者：张万青 郑文燕 王彩媚[1] 乔莉[1] 刘潇潇[1] ZHANG Wanqing;ZHENG Wenyan;WANG Caimei;QIAO Li;LIU Xiaoxiao(Guangdong Institute for Drug Control,Guangzhou 510700,China)

机构地区：[1]广东省药品检验所,广州510700

出　　处：《中国药品标准》2024年第3期282-288,共7页Drug Standards of China

摘　　要：目的:建立同时测定康复新液中10种抑菌剂的高效液相色谱分析方法。方法:采用Thermo Acclaim TM 120(4.6 mm×250 mm,5μm)色谱柱,流动相为0.1%冰醋酸-0.02 mol·L^(-1)乙酸铵溶液和甲醇,梯度洗脱,流速为1 mL·min^(-1),扫描波长为200~700 nm。结果:在相应的浓度范围内,10种抑菌剂质量浓度与峰面积的线性关系良好,r≥0.9998;精密度试验良好,RSD在0.33%~0.38%;重复性试验与稳定性试验的RSD<0.5%,加标回收范围为97.4%~101.1%,RSD在0.4%~1.8%之间。按拟定方法测试样品苯甲酸含量在0.15%~0.34%范围,山梨酸含量在0~0.48%范围,羟苯乙酯含量在0~0.02%范围、羟苯丙酯含量再0~0.02%范围。结论:该方法灵敏快速、专属性强、准确度高,可用于康复新液中抑菌剂的含量测定。Objective:To establish a high-performance liquid chromatography(HPLC)method for the simultaneous determination of 10 bacteriostatic agents in Kangfuxin solution.Methods:The HPLC method parameters were as follows,a Thermo Acclaim TM 120 column(4.6 mm×250 mm,5μm),a gradient mobile phase of 0.1%glacial acetic acid-0.02 mol·L^(-1)ammonium acetate solution and methanol at a flow rate of 1 mL·min^(-1),and the scanning wavelength of 200-700 nm.Results:In the corresponding concentration range,the linear relationship between the mass concentration of the 10 bacteriostatic agents and the peak area was good(r≥0.9998);the precision was good with RSD of 0.33%-0.38%;The RSD values of the repeatability test and the stability test were<0.5%,the recovery rate was 97.4%-101.1%,and the RSD was between 0.4%-1.8%.According to the proposed method,the content results of benzoic acid,sorbic acid,hydroxyphenyl ethyl ester and hydroxyphenyl propyl ester in the test sample were 0.15-0.34%,0-0.48%,0-0.02%,and 0-0.02%,respectively.Conclusion:This method is sensitive,rapid,specific and accurate,and can be used for the determination of the content of bacteriostatic agents in Kangfuxin solution.

关 键 词：康复新液 HPLC-DAD 抑菌剂 苯甲酸 山梨酸 羟苯甲酯 醋酸氯己定 

分 类 号：R921.2[医药卫生—药学]