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目的采用HPLC法测定盐酸替罗非班氯化钠注射液中D-异构体的含量。方法用C18萃取小柱富集盐酸替罗非班与D-异构体;色谱柱为Chiralpak IC手性柱(250 mm×4.6 mm,5μm),流动相为正己烷-异丙醇-甲醇-乙二胺-冰乙酸(300∶400∶300∶3∶3),检测波长为227 nm。结果盐酸替罗非班与D-异构体的分离度为3.76,D-异构体0.667~5.336μg·m L-1与峰面积的线性关系良好(r=0.9999),平均回收率为93.43%,RSD=1.79%(n=9)。结论所用方法操作简便,分离效果好,可用于盐酸替罗非班氯化钠注射液中D-异构体的测定。
Objective To determine the content of D-isomer in tirofiban hydrochloride and sodium chloride injection by HPLC. Methods Tirofiban and D-isomers were enriched with C18 column. Chiralpak IC chiral column (250 mm × 4.6 mm, 5 μm) was used as the chromatographic column. The mobile phase was n-hexane-isopropanol-methanol- Ethylenediamine - glacial acetic acid (300: 400: 300: 3: 3), detection wavelength of 227 nm. Results The separation of tirofiban hydrochloride and D-isomer was 3.76, and the linear relationship between D-isomer 0.667 ~ 5.336μg · m L-1 and peak area was good (r = 0.9999). The average recovery was 93.43 %, RSD = 1.79% (n = 9). Conclusion The method is simple and convenient to operate and can be used for the determination of D-isomer in tirofiban hydrochloride and sodium chloride injection.