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目的采用RP-HPLC测定盐酸氨溴索葡萄糖注射液中的有关物质。方法采用RP-HPLC,C18柱,以0.1mol·L-1醋酸铵溶液-甲醇(40∶60)为流动相;检测波长为246nm。结果杂质B相对于盐酸氨溴索的校正因子为1.47,盐酸氨溴索和杂质B的最低检出限分别为0.75ng和1.5ng,盐酸氨溴索与其他杂质峰的分离度符合要求。结论采用RP-HPLC测定盐酸氨溴索葡萄糖注射液中的有关物质方法简便、灵敏、专属性强。
Objective To determine the related substances in ambroxol hydrochloride injection by RP-HPLC. Methods RP-HPLC, C18 column with 0.1 mol·L-1 ammonium acetate solution-methanol (40:60) as the mobile phase was used. The detection wavelength was 246 nm. Results The calibration factor of impurity B relative to ambroxol hydrochloride was 1.47. The detection limits of ambroxol hydrochloride and impurity B were 0.75 ng and 1.5 ng, respectively. The separation of ambroxol hydrochloride and other impurity peaks was satisfactory. Conclusion The determination of related substances in ambroxol hydrochloride injection by RP-HPLC is simple, sensitive and specific.