注射用盐酸头孢替安与临床常用溶剂的配伍稳定性研究

Study on the compatible stability of cefotiam hydrochloride for injection with conventional clinical solvents

目的 考察注射用盐酸头孢替安与2种常用注射用配伍溶剂的配伍稳定性。方法考察配伍后0、2、4、8 h的溶液澄清度与颜色、渗透压摩尔浓度;并采用高效液相色谱(HPLC)测定配伍后的含量、有关物质、5-羟甲基糠醛情况;产生的主要未知杂质经柱切换的液相质谱联用(LCMS-IT-TOF)定性。结果 注射用盐酸头孢替安与常用溶剂配伍后,在室温下存放8 h,颜色变深,有关物质增加明显,产生的主要未知杂质经定性确定为聚合物杂质。结论在室温条件下,注射用盐酸头孢替安与0.9%氯化钠注射液、5%葡萄糖注射液配伍后不稳定,应立即使用。

Objective To investigate the compatible stability of cefotiam hydrochloride for injection with two common compatible solvents for injection. Methods The clarity and color, and osmolality of the solution were investigated at 0 h, 2 h, 4 hand 8h after compatibility;and the content, related substances and 5-hydroxymethylfurfural were determined by high efficiency liquid chromatography(HPLC) after compatibility;the main unknown impurities produced were qualitatively determined by liquid chromatography-electrospray(LCMS-IT-TOF) with column switching. Results The color became darker and related substances increased significantly, after cefotiam hydrochloride for injection was prepared with conventional solvents and stored at room temperature for 8 hours;the main unknown impurities produced were qualitatively determined as polymer impurities. Conclusion Cefotiam hydrochloride for injection is unstable after prepared with 0.9% sodium chloride injection and 5% glucose injection at room temperature, and should be used immediately.