RP-HPLC法测定氢溴酸樟柳碱原料药的有关物质

RP-HPLC determination of related substances of anisodine hydrobromide

目的:建立 RP—HPLC 法测定氢溴酸樟柳碱原料药的有关物质。方法:采用 RP—HPLC 法,色谱柱为 Reliasil ODS C_(18)柱(4.6 mm×250 mm,5μm);流动相为甲醇-0.01 mol·L^(-1)磷酸二氢钾溶液(取磷酸二氯钾1.36 g 与庚烷磺酸钠4.04 g,加水溶解并稀释至1000 mL,用磷酸调 pH 为3.5)(38:62),流速1.0 mL·min^(-1);检测波长210 nm;进样量10μL;柱温30℃。结果:此条件下,以自身对照测定有关物质分别为0.12%,0.13%,0.15%。结论:本方法简便、快速、稳定性好,可用于氢溴酸樟柳碱原料药的有关物质。

Objective：To establish a method to determine related substance in anisodine hydrobromide. Method： Reliasil ODS C18 column （4.6 mm × 250 mm,5 μm） was adoptd with methane -0.01 mol·L^-1 potassium dihydrogen phosphate （ 1.36 g ·L^-1 potassium dihydrogen phosphate and 4.04 g ·L^-1 sodium heptanesulfonate in it, adjusted to pH of 3.5 with phosphoric acid）（38： 62） as mobile phase at flow rate of 1.0 mL ·min^-1. The injection volumn was 10 μL and the detect wavelength was set at 210 nm. The column temperature was 30 ℃. Results： Results of related substances was 0. 12 % ,0. 13 % ,0. 15 %. Conclusion ： The method is simple, rapid, accurate and reproducible, it can be used for determination of related substance of anisodine hydrobromide.