HPLC法测定加替沙星胶囊的含量  

Determination of Gatifloxacin in Gatifloxacin Capsules by HPLC

作　　者：徐勤[1] 秦雪莲[1] 邓立东[2] 张正行[3] 

机构地区：[1]桂林医学院药学院分析教研室,桂林541004 [2]桂林医学院附院药剂科,桂林541001 [3]中国药科大学药物分析研究室,南京210009

出　　处：《药物分析杂志》2004年第5期538-541,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:采用HPLC测定加替沙星胶囊的含量及有关物质。方法:用C18柱,流动相为甲醇-三乙胺-0.02 mol·L-1磷酸二氢钾缓冲液(39.4:0.6:60),pH为3.5,流速1.0 mL·min～1,293 nm为检测波长。结果:在建立的色谱条件下,加替沙星与其杂质能完全分离,在2.0-20 μg·mL-1范围内,面积与其浓度线性关系良好(r=0.9999);样品的平均回收率为101.5%,RSD为0.7%(n=9)。结论:该方法准确,简便,快捷,重复性好。Objective: To develop an HPLC method for the assay of the content of gatifloxacin and its related substances. Methods :C18 column was used as the stationary phase. The mobile phase contained MeOH - triethylamine -0.02 mol · L-1 K2HPO4(39.4:0.6:60) ,pH =3.5. Flow rate was 1.0 mL · min-1. The UV detection wavelength was 293 nm and column temperature was room temperature. Results; Under the described chromatographic condition gatifloxacin was completely separated from its impurities. The calibration curve was linear(r = 0. 9999) in the range of 2.0 -20 μg · mL-1 for gatifloxacin,the mean recovery was 101. 5% ,with RSD 0. 7% (n =9). Conclusion: The method is simple,rapid and accurate.

关 键 词：加替沙星 胶囊 HPLC法 含量 有关物质 HPLC测定 色谱条件 磷酸二氢钾 C18柱 平均回收率 

分 类 号：R927.2[医药卫生—药学] R978