高效液相色谱法测定盐酸加替沙星的含量

DETERMINATION OF GATIFLOXACIN IN GATIFLOXACIN HYDROCHLORIDE TABLETS BY HPLC

目的建立高效液相色谱法测定盐酸加替沙星片中加替沙星的含量。方法采用钻石C18色谱柱(250 mm×4.6 mm,5μm),以乙腈-0.01 mol/L磷酸溶液(20:80)(用三乙胺调节pH至3.0)为流动相,检测波长为293 nm,流速为1.0 mL/min。结果加替沙星的浓度在10～120 μg/mL范围内与峰面积呈良好的线性关系.r=0.999 9。平均回收率为99.7%,相对标准差为1.29%(n=9)。结论本方法简便、准确、灵敏度高、专属性强、重现性好,可用于盐酸加替沙星片的质量控制。

Objective To establish a method for the determination of gatifloxacin in gatifloxacin hydrochloride tablets by high performance liquid chromatography （HPLC）. Methods The analysis was carried on with diamonsil C18 column（250 mm× 4.6 mm, 5 /,m）. The mobile phase was composed of acetonitrile 0.01 mol/L phosphoric acid solution （20：80） （adjusting the pH to 3.0 with triethylaemine）. Detection wavelength was 293 nm and the flow rate was 1.0 mL/min. Results The calibration curve was linear between 10- 120μg/mL, r = 0.9999. The average recovery and RSD for gatifloxacin were 99.7% and 1.29% （n = 9） respectively. Conclusion This method is simple, accurate, sensitive, specific, reproducible, and suitable for the quality control of gatifloxacin hydrochloride tablets.