海勒氏液中苯甲酸、水杨酸的含量测定  

Determination of benzoic acid and salicylic acid in Haileshi Ye

作　　者：李秀敏[1] 赵颖[1] 杨宁[2] 黄力[2] 

机构地区：[1]北京军区总医院药剂科,北京100700 [2]北京军区药品仪器检验所,北京100071

出　　处：《药物分析杂志》2015年第11期2032-2035,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的：建立HPLC法测定海勒氏液中苯甲酸、水杨酸含量,提高海勒氏液的质量标准。方法：采用十八烷基硅烷键合硅胶色谱柱（150 mm×4.6 mm,5μm）色谱柱,以甲醇-0.1%磷酸（50∶50）为流动相,流速1.0 m L·min-1;检测波长240 nm;柱温35℃。结果：苯甲酸及水杨酸线性范围分别为7.95~119.25μg·m L-1,（r=1.000 0）和5.06~75.97μg·m L-1（r=0.999 9）;平均回收率（n=9）分别为99.6%、99.3%、98.8%和98.2%、99.2%、99.7%。3批样品中苯甲酸含量分别为91.5、76.6和89.9 mg·m L-1,水杨酸含量分别为50.4、48.4和49.9 mg·m L-1。结论：该方法可用于海勒氏液中苯甲酸和水杨酸的含量测定。Objective： To establish an HPLC method for determination of benzoic acid and salicylic acid, and improve the quality standard of Haileshi Ye. Methods： HPLC analysis was carried out with VP-ODS column（ 150mm × 4. 6 mm,5 μm） and methanol-0. 1% phosphoric acid solution （50： 50） at a flow rate of 1.0 mL. min -1. The detection wavelength was at 240 nm, and the column temperature was 35 ℃. Results： The linear ranges of benzoic acid and salicylic acid were 7.95-119.25 μg·mL - 1 （ r = 1. 000 0 ） and 5.06 - 75.97 μg·mL - 1 （ r = 0. 999 9 ）, respectively ; and the average recoveries （ n = 9 ） were 99.6% , 99. 3 %, 98.8 % and 98.2% , 99.2% , 99.7 % , respec- tively. The contents of benzoic acid and salicylic acid in 3 samples were 91.5,76. 6,89.9 mg· mL-1 and 50. 4, 48.4,49.9 mg · mL-1, respectively. Conclusion： This method can be used for the determination of benzoic acid and salicylic acid in Haileshi Ye.

关 键 词：海勒氏液 苯甲酸 水杨酸 碘酊 高效液相色谱法 医院制剂质量标准 

分 类 号：R917[医药卫生—药物分析学]