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目的:通过对有关物质检查方法比较,建立本品有关物质检查方法。方法:采用高效液相色谱,色谱柱选用氨基色谱柱,以0.1mol/L磷酸二氢钠-甲醇-乙腈-高氯酸钠(900∶30∶40∶30)为流动相,流速1.0ml/min,220nm为本品的检测波长,氧化槐果碱与苦参素分离度符合规定,氧化槐果碱线性为3.0~18.0ug/ml,专属性试验表明供试品与降解产物可有效分离,峰纯度符合规定,物料平衡,苦参素检测限为3.1ng,氧化槐果碱检测限为1.9ng,溶液稳定性试验结果表明供试品溶液在8小时内稳定。结论:所建立含量测定方法可行,可用于测定本品有关物质。
Objective: Through the comparison of the relevant material inspection methods, the establishment of the material related substances inspection methods. Methods: High performance liquid chromatography (HPLC) was used. The column was eluted with 0.1mol / L sodium dihydrogen phosphate-methanol-acetonitrile-sodium perchlorate (900:30:40:30) min, 220nm for the detection wavelength of this product, the oxide of sophocarpine and matrine resolution in line with the provisions of oxygenated sophocarpine linearity of 3.0 ~ 18.0ug / ml, the proprietary test showed that the test products and degradation products can be effectively separated, Peak purity compliance, material balance, the detection limit of matrine is 3.1ng, the detection limit of oxine cassia was 1.9ng, the solution stability test results show that the test solution was stable within 8 hours. Conclusion: The established method for determination of content is feasible and can be used to determine the related substances of this product.