紫杉醇注射液含量及其有关物质的检测

Determination of paclitaxel and related substance by HPLC

目的 测定紫杉醇注射液含量及其有关物质。方法 采用高效液相色谱法 ,C18柱 ,流动相为甲醇 pH 5 .0的缓冲液 ,检测波长 2 5 4nm。结果 紫杉醇在 0 .1～ 0 .5mg·mL-1的范围内 ,线性关系良好 (r =0 .9998,n =5 ) ,平均回收率为 98.7% ,最小检测量 0 .1μg ,有关物质含量低于 4%。 结论 方法简便、快速、准确、重现性好 。

OBJECTIVE: To develop an assay for the determination of paclitaxel and related substance. METHODS: A C18 column was used. The mobile phase consisted of methanol-pH 5.0 triethylamine buffer and the detection wavelength was at 254 nm. RESULTS: The calibration curve for paclitaxel was linear over the concentration range of 0.1 ∼ 0.5 mg&middotmL-1 r = 0.999 8, n = 5). The average recovery was 99.8%. The limit of detection for paclitaxel was 0.1 μg. The amount of related substance was under 4%. Conclusion: The method had the advantages of simplicity, rapidity, accuracy and precision.