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目的：建立新的高效液相色谱测定氢溴酸美沙芬及其杂质含量的方法。方法：色谱条件以ＹＷＧＣ１８Ｈ３７为色谱柱；乙腈０．１ｍｏｌ·Ｌ－１磷酸二氢钾（５５∶４５）用磷酸调ｐＨ至４（含量）和２．５（杂质）为流动相；检测波长为２８０ｎｍ；并以对乙酰氨基酚为内标测定含量。结果：含量线性范围为８０～１２０μｇ·ｍｌ，回归方程Ｙ＝－０．０５９６＋０．１３１９Ｘ，ｒ＝０．９９９９（ｎ＝５），ＲＳＤ＝０．８２％。Ｎ，Ｎ二甲基苯胺测定最低浓度为０．１μｇ·ｍｌ－１。结论：含量测定方法简便、快速，结果准确。杂质测定灵敏度高，优于药典方法。
Objective: To establish a new method for the determination of methadone hydrobromide and its impurity by high performance liquid chromatography. Methods: Chromatographic conditions YWGC18H37 column; acetonitrile 0.1mol·L-1 potassium dihydrogen phosphate (55:45) with phosphoric acid to adjust the pH to 4 (content) and 2.5 (impurities) as the mobile phase; detection wavelength 280nm; and paracetamol as the internal standard determination of content. Results: The linear range was 80 ~ 120μg · ml. The regression equation was Y = -0.0596 + 0.1319X, r = 0.9999 (n = 5), RSD was 0.82%. N, N-dimethyl aniline determination of the lowest concentration of 0.1μg · ml-1. Conclusion: The content determination method is simple, rapid and accurate. High impurity detection sensitivity, superior to pharmacopoeia.