目的:建立左乙拉西坦注射液与氯化钠、葡萄糖、乳酸钠林格注射液配伍后在不同输液器中的甲苯和苯乙烯迁移的分析方法.方法:采用菲罗门C18色谱柱(ø4.6 mm × 150 mm),甲醇-水(体积比65∶35)为流动相,流速为1 mL/min,进样体积100 μL,检测波长210 nm,柱温40 ℃,测定甲苯和苯乙烯的含量.结果:甲苯和苯乙烯的响应值和浓度均呈线性相关,相关系数均大于0.999,定量限均远低于甲苯和苯乙烯的控制限度.结论:建立的方法适合检测左乙拉西坦注射液的配伍溶液使用给药器具的后甲苯和苯乙烯的含量.
Study on the Compatibility between the Compatibility Solution of Levetiracetam Injection and the Drug Delivery Device
(Objective)To establish an analytical method for the migration of toluene and styrene in different medical devices after the combina-tion of levetiracetam injection with sodium chloride injection,glucose injection,and sodium lactate Ringer injection.(Methods)The content of toluene and styrene was determined using a phenomenex C18 column(4.6 mm × 150 mm),methanol-water(65∶35,V/V)as the mobile phase,a flow rate of 1 mL per minute,an injection volume of 100 μL,a detection wavelength of 210 nm,and a column temperature of 40 ℃.(Re-sults)The response values and concentrations of toluene and styrene were linearly correlated,with correlation coefficients greater than 0.999,and the limits of quantification were much lower than the limits of control of toluene and styrene.(Conclusions)The established method is suit-able for detecting the content of toluene and styrene in the compatibility solution of levetiracetam injection using medical device.
万方数据
维普
