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目的:将酒石酸双氢可待因质量标准在现有基础上作一定调整,同时参考英国药典2009版,将原来检查项目下的可待因和吗啡检查项并入有关物质检查项中。方法:照高效液相色谱法对检测方法的专属性、检测限和耐用性进行实验。结果:在设定的色谱条件下,波长选择280nm时,双氢可待因与可能的各种杂质在微量存在时均可被检测出,该色谱系统条件用于酒石酸双氢可待因有关物质分析灵敏、可靠。结论:该方法可用于酒石酸双氢可待因有关物质的分析,而且在原有方法上作了进一步提高,可使酒石酸双氢可待因样品有关物质的分析更加精密、准确,保证了产品的质量。
OBJECTIVE: To adjust the quality standard of dihydrocodeine tartrate on the basis of existing standards, and to make reference to British Pharmacopoeia 2009 edition, and to integrate the codeine and morphine under the original test item into the related items inspection items. Methods: The HPLC method was used to test the specificity, detection limit and durability of the assay. Results: Dihydrocodeine and all kinds of possible impurities could be detected in the presence of trace amount under the chromatographic conditions set at 280 nm, and the chromatographic conditions were used for dihydrocodeine tartrate related substances Analysis is sensitive and reliable. Conclusion: This method can be used for the analysis of related substances of dihydrocodeine tartrate, and further improved in the original method, which can make the analysis of dihydrocodeine tartrate related substances more precise and accurate, and ensure the quality of the product .