HPLC测定普卢利沙星含量及有关物质  

Determination of Prulifloxacin Content by HPLC

作　　者：王静 廖昌军[2] WANG Jing;LIAO Changjun(Health Science Center,Dali University,Yunnan Dali 671000;College of Pharmaay,Chengdu Medicial College,Sichuan Chengdu 610500,China)

机构地区：[1]大理大学医学部,云南大理671000 [2]成都医学院药学院,四川成都610500

出　　处：《广州化工》2025年第3期112-115,共4页GuangZhou Chemical Industry

摘　　要：普卢利沙星片是一种常见的合成抗菌药,其主要治疗由敏感菌引起的皮肤和软组织感染,肛门周围脓肿,外伤、烫伤、手术等浅表性继发性感染,呼吸系统感染,泌尿生殖系统感染、胆囊炎、胆管炎,感染性肠炎、细菌性痢疾、伤寒、霍乱和眼、耳、鼻感染。主要成分是普卢利沙星。分子式是C_(21)H_(20)FN_(3)O_(6)S。本论文通过建立高效液相色谱法检测普卢利沙星及有关物质含量的方法,为普卢利沙星质量标准提供检测依据。方法:安捷伦C_(18)色谱柱(4.6×50 mm,1.7μm);用0.005 mol/L的磷酸二氢钾溶液(含有0.1%的三乙胺,用磷酸调节使pH为4)∶乙腈(55∶45)为流动相,流速为1 mL/min,检测波长为278 nm,柱温为30℃。结果:在10.024~200.48μg/L范围内线性良好(r=0.9999),加样回收率为102.61%,RSD为1.18%,结论:本文中建立的方法简单,准确,易行且重现性好,可作为普卢利沙星含量测定的有效方法。Prulifloxacin tablets are a common synthetic antibacterial drug that mainly treats skin and soft tissue infections caused by sensitive bacteria,perianal abscesses,superficial secondary infections such as trauma,burns,surgery,respiratory system infections,urogenital system infections,cholecystitis,cholangitis,infectious enteritis,bacterial dysentery,typhoid fever,cholera,and eye,ear,and nose infections.to establish a method using HPLC determination of prulifloxacin content,The main ingredient is prulifloxacin.The molecular formula is C_(21)H_(20)FN_(3)O_(6)S.This paper establishes a method for detecting the content of prulifloxacin and related substances by high-performance liquid chromatography,providing a detection basis for the quality standard of prulifloxacin.Agilent C_(18)column(4.6 mm×50 mm,1.7 m);0.005 mol·L^(-1)with potassium dihydrogen phosphate(triethyl amine,containing 0.1%pH was adjusted with phosphoric acid 3.8):acetonitrile(60∶40)as the mobile phase,the flow rate was 1 mL·L^(-1),the detection wavelength was 278 nm,the column temperature was 30 degrees Celsius.Good linearity in the range of 10.14~202.8μg·L^(-1)range(r=0.9999),Recovery rate was 102.61%and RSD was 1.18%.The method established in this paper is simple,accurate,reliable and reproducible.It can be used as an effective method for the determination of prulifloxacin.

关 键 词：普卢利沙星 含量测定 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]