HPLC测定克班宁注射液中原料药的有关物质

Determination of related substances in drug substance of Crebanine injection by HPLC

目的分析克班宁注射液原料药中的有关物质。方法应用HPLC法测定不同来源的10批克班宁原料药样品。采用Zirchrom ODS柱（250mm×4．6mm），以流动相A和B作梯度洗脱[（A为甲醇-水-10％三乙胺（50：50：0．5），B为甲醇-10％三乙胺（100：0．5）]；流速1．0ml·min^-1，检测波长282nm，分析时间45min。结果10批原料药中有两个有关物质共有峰，其中5批有6个有关物质共有峰，有关物质峰占总峰面积的3．04％～23．94％。结论所建分析方法灵敏、重复性好，为克班宁原料药的质量控制提供了依据。

OBJECTIVE To analyze the kind and content of related substances in drug substance of Crebanine injection by HPLC.METHODS 10 batches of sample collected from different species or growing areas were analyzed. HPLE was used with Zirchrom ODS cdurnn （250 mm×4.5 mm）. A mobile phase was adopted with gradient elution at the flow rate of 1.0 ml·min^- 1 for 45 rain. Phase A was methanol - water - 10% triethylamine（50：50：0.5） and phase B was methanol - 10 % triethylamine （ 100：0.5 ）. UV detective wavelength was set at 270 nm. RESULTS There were 2 common peaks of related substance in 10 batches of the sample and 6 common peaks in 5 batches. The total area of common peaks of related substance were 3.04 % - 23.94 % of all peaks. CONCLUSION The method is accurate and reproducible. The determination offers evidence for quality control of drug substance of Crebanine injection.