摘要
目的:建立一种新的紫杉醇注射液的高效液相色谱测定方法。方法:采用高效液相色谱法,色谱柱为日本岛津公司ODS柱(4.6×250mm,5μm),流动相为醋酸-水-甲醇(0.1∶30∶70),流速为1.0mL/min,柱温为35℃,检测波长为227nm,进样量为10μL。结果:紫杉醇浓度在8.8-35.2μg/ml范围内呈良好线性,峰面积与进样量呈良好线性关系,r=0.9998;平均回收率为101.3%。结论:本文建立的方法,简便,重现性好,可用于紫杉醇注射液的含量测定。
Objective: To establish a new HPLC method for determination of Paclitaxel Injection. Method : The concenlration of Paclitaxel Injection was assayed on a Shim-Pack CLC-ODS column (4.6 × 250mm, 5μm)with a mobile phase consisting of acetic acid-water-methanol(0.1 : 30 : 70)at a flow rate of 1.0ml/min and detected at 227nm. The column temperature was 35℃. Results : The calibration curve was linear(r=0. 9998)in the range of 8.8-35.2μg/mL for paclitaxel. The mean recovery was 101.3 %. Conclusion:The improved method was a sensitive,reproducible and simple assay. It is suitable for the determination of Paclitaxel Iniection.
出处
《中国药品标准》
CAS
2006年第5期29-31,共3页
Drug Standards of China