HPLC法测定异长春花碱静脉注射乳剂中主药的含量

Content Determination of Main Component in Intravenous Emulsion of Vinorelbine by HPLC

目的:建立以高效液相色谱法测定异长春花碱静脉注射乳剂中主药含量的方法。方法:色谱柱为Gemini C18,流动相为乙腈-0.06mol·L-1磷酸二氢钾(用盐酸调pH至3.0)=35∶65,流速为0.8mL·min-1,检测波长为215nm,柱温为30℃,进样量为5μL。结果:异长春花碱检测浓度的线性范围为0.08～0.80mg·mL-1(r=0.9999);平均加样回收率为99.33%,日内RSD=0.95%,日间RSD=1.14%。结论:本方法简便、准确、重复性好,可用于该制剂的含量测定。

OBJECTIVE： To establish an HPLC method for determination of the content of main component in intravenous emulsion of vinorelbine. METHODS： The content of vinorelbine was determined by HPLC on Gemini C,8 column with mobile phase consisted of acetonitrile- 0.06 mol ·L -1 KDP buffer （pH was adjusted to 3.0 by hydrochloric acid） （35 ： 65） at a flow rate of 0.8 mL · min-1. The detection wavelength was set at 215 nm; the column temperature was set at 30 ^（7, and the in- jection volume was 5μL. RESULTS： The linear range of vinorelbine was 0.08--0.80 mg · mL-1 （r = 0.999 9） and the av- erage recovery rate was 99.33% with intra- day RSD at 0.95% and inter- day RSD at 1.14%. CONCLUSION： The method is simple, accurate and reproducible, and it is applicable for the determination of the intravenous emulsion of vinorelbine.