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目的建立盐酸羟考酮及其制剂中主要杂质氮氧化物的鉴别溶液,解决国内缺少该杂质对照品的问题。方法将盐酸羟考酮溶解,双氧水加热破坏的方法得到氮氧化物的鉴别溶液。结果与结论经HPLC、UV和LC-MS/MS验证,该鉴别溶液中的羟考酮氮氧化物与对照品结构一致,为同一物质,可用于盐酸羟考酮及其制剂中主要杂质羟考酮氮氧化物的定位鉴别。
OBJECTIVE To establish the identification solution of oxycodone hydrochloride and its main impurity nitrogen oxides in preparation, to solve the problem of lack of reference substance of this impurity in China. Methods Dissolution of oxycodone hydrochloride and hydrogen peroxide solution were used to obtain the identification solution of nitrogen oxides. RESULTS AND CONCLUSION: The results of HPLC, UV and LC-MS / MS showed that the structure of oxycodone oxynitride in this identification solution was the same as that of the reference substance and it was the same substance and could be used for the determination of oxycodone hydrochloride and its major impurities in its preparation. Identification of Ketones Nitrogen Oxides.