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
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摘要: 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38.55～57.82 μg/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。Abstract: 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 25μg/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.
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Keywords:
- moxifloxacin hydrochloride /
- HPLC /
- content determination /
- related substances
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