高三尖杉酯碱及其制剂有关物质的研究

目的：建立RP-HPLC测定高三尖杉酯碱及其制剂有关物质的方法，并用其分析不同处理后高三尖杉酯碱有关物质的量。方法采用Germsil-PC18色谱柱（250×4.6mm，5μm），以10mmol·L-1磷酸二氢钾溶液为流动相A，甲醇为流动相B，梯度洗脱，流速1mL·min-1，检测波长288nm，柱温30℃。结果高三尖杉酯碱在2-30μg的范围内与峰面积呈良好的线性关系，r=0.9996；以高三尖杉酯碱进样量为20μg重复进样6次，杂质A、杂质B、高三尖杉酯碱的RSD分别为3.28%，4.69%，1.12%。结论应用本方法精确可以测定高三尖杉酯碱中杂质A、杂质B等有关物质的量及高三尖杉酯碱的含量。

Research for Homobarringtonie and Related Substances of Its Preparations

Objective To build up RP-HPLC method for measuring homobarringtonie and related substances of its preparations, and to analyze the content of homobarringtonie related substances after different treatment. Methods Apply Germsil-P C18 chromatographic column （250×4.6 mm, 5μm）and use 10 mmol·L-1 monopotassium phosphate as flow phase A while methanol as B. Apply gradient elution with the flow rate 1 mL·min-1, check the wavelength 288 nm with column temperature at 30 ℃. Results Homobarringtonie presented great linear relationship with peak area in the range of 2-30μg, with r=0.9996;when loading 20μg homobarringtonie in 6 repeats, impurity A, impurity B, and homobarringtonie RSD were 3.28%, 4.69%, and 1.12%, respectively. Conclusion Applying this method can precisely measure the content of homobarringtonie, and related substances, such as impurity A and impurity B.