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目的建立高效液相色谱法(HPLC)测定盐酸美沙酮口服液中盐酸美沙酮的含量。方法采用岛津LC-2010AHT,DIAMONDC18(250mm×4.6mm,5μm)色谱柱;流动相为乙腈-0.02mol·L-1磷酸二氢钾溶液(50:50),用2mol·L-1磷酸或氢氧化钠溶液调节pH为5.5;检测波长220nm,柱温为40℃,流速1ml·min-1。结果盐酸美沙酮在10～100μg·mL-1的范围内与其峰面积呈良好线性关系,r=0.9999(n=6),平均回收率为100.6%,RSD=0.5%(n=9)。结论该方法简单、快速、准确。
Objective To establish a high performance liquid chromatography (HPLC) method for the determination of methadone hydrochloride in oral solution of methadone hydrochloride. Methods The mobile phase was acetonitrile-0.02mol·L-1 monobasic potassium phosphate solution (50:50) with 2mol·L-1 phosphoric acid or Sodium hydroxide solution to adjust the pH to 5.5; detection wavelength 220nm, column temperature 40 ℃, flow rate 1ml · min-1. Results There was a good linear relationship between the concentration of methadone hydrochloride and its peak area in the range of 10 ~ 100μg · mL-1, r = 0.9999 (n = 6). The average recovery was 100.6% with RSD = 0.5% (n = 9). Conclusion The method is simple, fast and accurate.