反相高效液相色谱法测定加替沙星胶囊中加替沙星及有关物质的含量

Determination of gatifloxacin and its related compound in gatifloxacin capsules by RP-HPLC

目的 建立测定加替沙星胶囊中加替沙星及有关物质含量的高效液相色谱法。方法 以ShimpackCLC ODSC18( 5 μm ,15 0mm× 4 .6mm)为色谱柱 ;流动相 :以 0 .0 2mol/L磷酸二氢钾缓冲液 (用磷酸调pH 4 .0 ) 乙腈 ( 85∶15 )配制的 0 .0 0 2mol/L四丁基溴化铵溶液为流动相 ;检测波长 :UV 2 93nm ;流速 :1.0mL/min。结果 加替沙星在 4～ 32 μg/mL内线性关系良好 ,平均加样回收率为 99.6 % ,RSD为 1.75 % (n =9)。结论 该方法准确、灵敏度高 ,重现性好 。

OBJECTIVE To develop a RP HPLC method for the determination of gatifloxacin and its related compound in gatifloxacin capsules. METHOD The PHLC was performed on Shimpack CLC ODS C 18 column. The mobile phase consisted of 0.02mol/L monobasic potassium phosphate buffer acetonitrile(85∶15). The flow rate was 1.0 mL/min. The detection wavelength was set at 293nm.RESULTS The assay was linear over the range of 4～32μg/mL. The average recovery was 99.6%, with the RSD =1.75% ( n =9). CONCLUSION The method developed is accurate, sensitive and repeatable. It can be applied to the quality control of gatifloxacin capsules.