高效液相色谱法测定巴洛沙星片含量及有关物质  

RP-HPLC Determination of Balofloxacin Content and Related Substance in Its Tablets

作　　者：白青山 董芳 伏光华 

机构地区：[1]山东省临沂市药品检验所,临沂276001

出　　处：《药物分析杂志》2005年第10期1234-1236,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立高效液相色谱法测定巴洛沙星片的含量和有关物质。方法:采用 Zorhax SB C_(18)色谱柱(4.6mm×250 mm,5μm);以0.02 mol·L^(-1)磷酸二氢钾-甲醇(60:40,用磷酸调 pH 至3.5)为流动相;流速1.0 mL·min^(-1);检测波长:295 nm;柱温:40℃;进样量:20μL。结果:巴洛沙星线性范围为5～40μg·mL^(-1),r=0.9999;平均回收率为99.8%(RSD=0.56%),n=6。结论:该法简便准确,专属性好,可用于该制剂的质量控制及有关物质测定。Objective：To establish an RP - HPLC method for the determination of balofloxacin and related substance in its tablets. Method：Using a Zorbax SB C18 column （4. 6 mm ×250 mm,5 μm）. The mobile phase consisted 0. 02 mol · L^- 1 potassium dihydrogen phosphate solution - methanol （60： 40, adjusted to pH = 3.5 with phosphoric acid）, the flow rate was 1.0 mL · min^-1. The detection wavelength was 295 nm. The column temperature was 40 ℃. Inject volumn was 20 μL. Results： The linear range for the content of balofloxacin was 5 - 40 μg · mL^ - 1, r = 0. 9999 （ n = 5 ）. The average recovery of balofloxacin tablets was 99. 8% and its RSD was 0.56% （ n = 6）. Conclusion ： The method is specific, accurate and convenient, and can be used for quality control, and related substance determination of the balofloxacin tablets.

关 键 词：巴洛沙星片 HPLC 含量测定 有关物质 有关物质测定 高效液相色谱法 巴洛沙星 含量 磷酸二氢钾 C18色谱柱 

分 类 号：R978.1[医药卫生—药品] R286.0[医药卫生—药学]