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目的:建立测定重酒石酸氢可酮原料药中8种有关物质吗啡、双氢可待因、可待因、羟考酮、可待因酮、甲基可待因、二苯甲酮和蒂巴因的方法。方法:采用梯度洗脱的反相高效液相色谱法。色谱柱为Inertsil ODS-2,以辛烷磺酸钠-乙腈组成流动相体系进行梯度洗脱,流速为1.5 mL.min-1,检测波长为283 nm,柱温为40℃。检测3批样品中的有关物质。结果:重酒石酸氢可酮与各有关物质分离良好,其中重酒石酸氢可酮、蒂巴因、二苯甲酮检测浓度线性范围分别为1.020 5～20.410 0、0.508 5～20.340、0.10～40.00μg.mL-(1r分别为0.999 7、0.999 9、1.000 0);检测限分别为0.05、0.005、0.005μg。3批样品中均未检出已知杂质峰。结论:本法简便、专属、灵敏,可用于重酒石酸氢可酮原料药有关物质的测定。
OBJECTIVE: To establish a method for the determination of 8 related substances, morphine, dihydrocodeine, codeine, oxycodone, codeine, methylcodeine, benzophenone and tiba in hydrocodone bitartrate Because of the method. Methods: Reversed-phase high performance liquid chromatography with gradient elution. The chromatographic column was Inertsil ODS-2. The mobile phase consisted of sodium octane sulfonate and acetonitrile was eluted with a gradient of 1.5 mL · min-1. The detection wavelength was 283 nm and the column temperature was 40 ℃. Test 3 batches of samples of the relevant substances. Results: Hydrocodone bitartrate was well separated from other related substances. The linear ranges of hydrocodone bitartrate, benzbazole and benzalkonium chloride were 1.020 5 ~ 20.410 0,0.508 5 ~ 20.340,0.10 ~ 40.00μg .mL- (1r respectively 0.999 7,0.999 9,1.000 0); detection limits were 0.05,0.005,0.005μg. None of the 3 batches of samples detected known impurity peaks. Conclusion: This method is simple, specific, sensitive and can be used for the determination of related substances of hydrocodone bitartrate raw materials.