盐酸替罗非班清洁验证残留量测定方法的研究  

Study on determination method of the residues of Tirofiban Hydrochloride on cleaning validation

作　　者：平丽[1] 林春琴[1] 盖仁华[1] 

机构地区：[1]浙江大学药物安全评价研究中心,浙江杭州310058

出　　处：《时珍国医国药》2013年第1期31-32,共2页Lishizhen Medicine and Materia Medica Research

基　　金：国家自然科学基金青年基金(No.81102521)

摘　　要：目的建立生产系统中盐酸替罗非班清洁后残留量的测定方法,保证各设备的清洁效果。方法采用高效液相色谱法,以0.01 mol/L的磷酸二氢钾缓冲液(用磷酸调节pH至2.3)-乙腈(73∶27)为流动相,227 nm为检验波长,1.0 ml/min为流速进行测定。结果盐酸替罗非班在0.075～0.75μg/ml之间峰面积与浓度呈良好的线性关系(r=0.999 7),平均取样回收率为92.45%。结论该分析方法可用于盐酸替罗非班清洁验证的残留物检测。Objective Using a HPLC method to set up a method for determination of the content of Tirofiban Hydrochlolike on clening validation to assure the cleaning effect. Methods The mobile phase was 0.01 mol/L monobasic potassium phosphate buffer acetonitrile （73： 27）, the detection wavelength at 227 nm, flow rate was 1.0 ml/min. Results When the residues content Tiro- fiban were between 0.075 μg/ml and 0.75 μg/ml, the peak area and content was linear （ r = 0.999 7）, the average rate of re- covery was 92.45%. Conclusion That the analytical method can be used for validation of Tirofiban Hydrochloride clean residue detection.

关 键 词：盐酸替罗非班 残留量 测定 

分 类 号：R284.1[医药卫生—中药学]