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目的采用HPLC法测定盐酸替罗非班的含量及有关物质。方法采用Venusil XBD C_(18)色谱柱(250 mm×4.6 mm,5μm),流动相为0.01 mol·L~(-1)磷酸二氢钾缓冲液(磷酸调p H2.3)-乙腈(72∶28),流速1.0 m L·min~(-1),柱温35℃,检测波长227 nm。结果主成分与各杂质峰的分离度良好,盐酸替罗非班10.0~100.0μg·m L~(-1)与峰面积有良好的线性关系(r=0.9999),平均回收率为99.4%,RSD=1.3%(n=9),检测限和定量限分别为0.3、1.0 ng。结论所用方法专属性强、灵敏度高,适用于盐酸替罗非班的含量和有关物质的测定。
Objective To determine the contents of tirofiban hydrochloride and its related substances by HPLC. Methods Venusil XBD C 18 column (250 mm × 4.6 mm, 5 μm) was used. The mobile phase consisted of 0.01 mol·L -1 KH 2 PO 4 buffer : 28), the flow rate was 1.0 mL · min -1, the column temperature was 35 ℃ and the detection wavelength was 227 nm. Results The separation of main components and impurity peaks was good. Tirofiban hydrochloride had a good linear relationship (r = 0.9999) with the average peak area of 10.0 ~ 100.0 μg · m L -1 and the average recovery was 99.4% RSD = 1.3% (n = 9). The limits of detection and quantification were 0.3 and 1.0 ng, respectively. Conclusion The method used is specific and sensitive and suitable for the determination of tirofiban hydrochloride and related substances.