高效液相色谱法测定甲磺酸帕珠沙星注射液中右旋体的含量

Determination of dexpazufloxacin mesilate in pazufloxacin mesilate injection by HPLC

目的建立甲磺酸帕珠沙星注射液中右旋异构体含量的高效液相色谱测定方法。方法Shim pakCLC ODS柱 (15 0mm× 6 .0mm ,5 μm) ,流动相为L 异白氨酸硫酸铜溶液 (取L 异白氨酸 1.3g、硫酸铜 1.0g和水 10 0 0ml溶解用 0 .1mol/L盐酸或 0 .1mol/L氢氧化钠调pH至 3.5 ) 甲醇 (75∶2 5 ) ;检测波长 :32 0nm。结果甲磺酸帕珠沙星右旋体在 0 .5～ 10 0 μg/ml浓度范围内呈良好的线性关系 (r=0 .9993) ,平均回收率为 99.5 4 % ,RSD为 1.0 1% (n =9)。结论此法快捷、专属性及重现性好 ,可用于甲磺酸帕珠沙星和D 甲磺酸帕珠沙星杂质的含量测定。

PurposeTo establish a method for assay of dexpazufloxacin mesilate in pazufloxacin mesilate injection.MethodsA HPLC method was used with ODS column (150 mm×6.0 mm,5 μm).The mobile phase consisted of methanol-sulfate pentahydrate/L-isoleucine solution (25∶75), with the detection wavelength at 320 nm.ResultsThe linear range of dexpazufloxacin mesilate was 5～100 μg/ml (r=0.999 3).The average recovery was (99.54±1.01)%.ConclusionThis method was convenient,selective and reproducible for the assay of dexpazufloxacin mesilate in pazufloxacin mesilate injection.