盐酸替罗非班注射液中对映异构体分析方法的建立

Determination of enantiomer in tirofiban hydrochloride injection

目的建立HPLC法分析盐酸替罗非班注射液中的对映异构体。方法采用Ultron ESOVM(150 mm×4.6 mm,5μm)色谱柱,流动相为0.1%甲酸铵溶液(用甲酸调节溶液的pH值为4.0)-甲醇(85∶15),等度洗脱30 min,流速0.5 mL·min^(-1),柱温25℃,检测波长227nm,进样量100μL。结果盐酸替罗非班与其对映异构体能有效分离,分离度大于2.0,溶液在室温条件下12 h内稳定。对映异构体浓度在0.025~0.375μg·mL^(-1)与峰面积线性关系良好(r=0.9999);低、中、高质量浓度的平均加样回收率分别为100.86%、96.86%、98.04%,RSD分别为2.7%、1.4%、2.1%(n=3)。以自身对照法计算对异构体含量不大于0.5%。结论本法可用于盐酸替罗非班注射液中对映异构体的检测。

Objective To determine the enantiomer in tirofiban hydrochloride injection by HPLC.Methods The Ultron ES-OVM column(150 mm×4.6 mm,5μm)was used.The mobile phase was 0.1%ammonium formate solution(pH of the solution adjusted to 4.0 with formic acid)and methanol(85∶15),and equivalent elution for 30 min.The flow rate was 0.5 mL·min^(-1),the temperature was 25℃,the detection wavelength was 227 nm,and the injection volume was 100μL.Results Tirofiban hydrochloride and enantiomer were effectively separated with the resolution over 2.0.The solution was stable within 12 h at room temperature.The concentration of enantiomers showed good linearity within 0.025~0.375μg·mL^(-1)(r=0.9999).The average recoveries were 100.86%,96.86%,and 98.04%at low,medium and high concentrations with the RSD of 2.7%,1.4%,and 2.1%,respectively(n=3).The content of enantiomers calculated by self comparison method were not more than 0.5%.Conclusion The method is suitable for the determination of enantiomers in tirofiban hydrochloride injection.