摘要
目的建立以RP-HPLC法测定紫杉醇注射液的含量及有关物质的方法.方法采用RP-HPLC法,以ODS C18柱(250 mm×4.6 mm)为色谱柱.含量测定以甲醇-水-乙腈(20∶ 30∶ 50)为流动相,流速1.0 ml·min-1,检测波长228 nm;有关物质检查参照国家药品标准,采用梯度洗脱程序,便于将所有的杂质分离完全.结果紫杉醇在5～50 mg·L-1的范围内线性关系良好(r＝0.9998,n＝5),平均回收率为99.90%,最低检测限为1.92 ng,有关物质含量低于2.5%.结论方法灵敏、快速、准确,重复性试验结果良好,可用于紫杉醇注射液的质量控制.
Aim To develop a RP-HPLC method for the determination of paelitaxel content and the related substance in paelitaxel injection. Methods A RP-HPLC method was used. A C18 scolumn（250 mm ×4.6 mm,5 μm）- In methanol-water-acetonitrile（20： 30： 50） ,the flow was 1.0 mg·L^-1 ,and a UV detector of 228 nm was adopt. In the determination of related substanee,a gradient elution process was used according to national drugs standard. Results The calibration curve for paelitaxel was liner over the eonsentration range of 5 - 50 mg·L^-1 （ r = 0. 9998, n = 5 ）. The average recovery, was 99.90%. The limit of detection was 1.92 ng. The amount of related substance was under 2.5 %. Conclusion A sensitive, rapid, precise and reproducible HPLC method. It provided a reliable quality control method for paelitaxel injection.
出处
《安徽医药》
CAS
2005年第11期822-824,共3页
Anhui Medical and Pharmaceutical Journal
