摘要
目的建立测定加替沙星软胶囊中加替沙星含量的高效液相色谱法。方法采用反相高效液相色谱法,以Hypersil C18柱(250mm×4.6mm,10μm)为色谱柱,用三乙胺调节pH值至4.0±0.1的0.05mol/L枸橼酸溶液-乙腈(80∶20)为流动相,检测波长为292nm,流速1.0mL/min。结果加替沙星质量浓度在2.44～48.8mg/L范围内与峰面积线性关系良好,平均加样回收率为99.14%,RSD为0.52%(n=9)。结论所建立的方法准确、简便,适用于加替沙星软胶囊的质量控制。
Objective To establish a RP-HPLC for the determination of gatifloxacin in gatifloxacin capsules. Methods RP-HPLC method was adopted. Hypersil C18 column （250mm×4.6mm,10 μm） with UV detection at 292 nm,and the mobile phase consisted of acetonitrile- 0.05 mol/L citric acid solution adjusted to pH 4.0±0. 1 with triethylamine （20：80）.The flow rate was 1.0 mL/min. Resnlts The calibration curve was linear within the range of 2.44 -48.8 mg/L for gatifloxacin,the average recovery rate was 99.14% , RSD was 0. 52% （n =9）. Conclusion This method is simple,accurate and effective. It is suitable for the quality control of gatifloxacin capsules.
出处
《中国药业》
CAS
2008年第13期24-25,共2页
China Pharmaceuticals
