HPLC法测定盐酸莫西沙星含量及其有关物质

Determination of moxifloxacin hydrochloride and its related substances by HPLC

采用HPLC法对盐酸莫西沙星含量及其有关物质进行检测,色谱柱为Sepax BR-C18(250 mm×4.6 mm,5μm),流动相为甲醇-四丁基硫酸氢铵磷酸缓冲液(28∶72),检测波长为293 nm,柱温为45℃,流速为1.3 mL/min。在所建立的色谱条件下,盐酸莫西沙星与各杂质分离良好,盐酸莫西沙星浓度在38.55～57.82μg/mL范围内与峰面积呈良好线性关系(r=0.999 8),最低检测限为0.006 25μg/mL,定量限为0.025μg/mL。结果表明,所建立的方法专属性好,操作简便,可用于盐酸莫西沙星含量及其有关物质的含量测定。

An HPLC method was established for the determination of moxifloxacin hydrochloride and its related substances.The method was carried out on a Sepax BR-C18 column（250 mm×4.6 mm,5 μm） with a mobile phase consisting of methanol-buffer solution（tetrabutyl ammonium hydrogen sulfate 0.5 g,KH2PO4 1.0 g,H3PO4 3.4 g in 1 L of purified water）（28 ∶72）at the flow rate of 1.3 mL/min.The detection wavelength was 293 nm and column temperature was 45 °C.The calibration curves were linear over the range of 38.55-57.82 μg/mL（r=0.999 8）.The quantitative and detection limits were 0.025 μg/mL and 0.006 25 μg/mL respectively.Good chromatographic separation of moxifloxacin hydrochloride and its related substances were obtained.As a result,the established HPLC method is simple,and could be used for the determination of moxiflocain hydrochloride and its related substances.