HPLC法测定盐酸莫西沙星葡萄糖注射液中有关物质的含量

摘要

Objective To establish the determination method of the related substances in moxifloxacin hydrochloride and glucose injection. Methods High performance liquid chromatography(HPLC) was used for the determination of the known impurity A, B,C,D,E and the unknown impurities.The analysysis was performed on a BDS HYPERSIL C18 column(4.6mm×250mm,5μm).The mobile phase was composed of methanol(0.50g/L tetrabutylammonium hydrogen sulfate,1.0g/L monopotassium phosphate and 3.4g/L Posphoric acid mixed solution,28 ∶ 72).With the flow of 1.5mL/min.The detetection wavelength was 293nm. Results The chromatographic peak area and concentration of Moxacin hydrochloride showed a good linear relationship(r=0.9992),at the range of 0.1259-5.036μg/mL. The degree of precision:RSD was 0.78%.The detection limit and quantitation limit for moxacin hydrochloride were 0.74ng and 2.53ng.The stability of solution:test solution and contrast solution was stable in 8 hours. Conclusion This method is convenient,a good specificity,high sensitivity.It can be used for the determination of related substance of moxacin hydrochloride.%目的：建立高效液相法测定盐酸葡萄糖注射液中有关物质。方法采用高效液相色谱法测定已知杂质A,B,C,D,E和未知单杂。使用BDS HYPERSIL C18色谱柱（4.6mm×250mm，5μm），以甲醇（0.50g/L四丁基硫酸氢铵，1.0g/L磷酸二氢钾和3.4g/L磷酸混合溶液；28∶72）为流动相。流速：1.5mL/min，检测波长：293nm。结果盐酸莫西沙星进样质量在0.1259～5.036μg/mL（r=0.9992），浓度范围内，供试品溶液的浓度与峰面积线性良好。精密度：RSD为0.78%；最小检出限为0.74ng。定量限：供试品溶液峰面积的RSD%为4.24，最小定量限为2.53ng。溶液稳定性：供试品溶液及其对照溶液在8h内稳定。结论该方法简便、专属性好、灵敏度高，可用于盐酸莫西沙星葡萄糖注射液中有关物质的检测。