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目的:建立测定复方罗布麻片Ⅰ中盐酸异丙嗪含量的方法。方法:采用高效液相色谱法。色谱柱为Thermo C18柱,流动相为乙腈-甲醇-水-冰醋酸(49∶23∶28∶1,V/V/V/V,每100 ml含十二烷基硫酸钠0.41 g),检测波长为254 nm,流速为1.0 ml/min,柱温为40℃,进样量为10μl。结果:盐酸异丙嗪检测质量浓度在0.001 978~0.197 8 mg/ml范围内与峰面积积分值呈良好的线性关系(r=0.999 9);精密度、稳定性、重复性试验的RSD均≤1.0%;平均加样回收率为99.57%,RSD=0.48%(n=9)。结论:该方法操作简便、结果准确、专属性强,可用于复方罗布麻片Ⅰ中盐酸异丙嗪的含量测定。
Objective: To establish a method for determination of promethazine hydrochloride in Compound Apocynacapti Ⅰ. Methods: Using high performance liquid chromatography. The column was Thermo C18 column and the mobile phase consisted of acetonitrile-methanol-water-acetic acid (49:23:28:1, V / V / V / V, containing 0.41 g sodium dodecyl sulfate per 100 ml) The wavelength was 254 nm, the flow rate was 1.0 ml / min, the column temperature was 40 ℃ and the injection volume was 10μl. Results: Promethazine hydrochloride showed a good linear relationship with the peak area integral value (r = 0.999 9) in the range of 0.001 978-0.1997 mg / ml; RSD of precision, stability and repeatability test were both ≤ 1.0%; average recovery was 99.57%, RSD = 0.48% (n = 9). Conclusion: The method is simple, accurate and specific. It can be used for the determination of promethazine hydrochloride in Compound Apocynum Ⅰ.