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目的:建立盐酸文拉法辛含量HPLC及有关物质的测定方法。方法:以C8柱,乙腈-0.3mol/L磷酸二氢铵(40∶60)为流动相,流量为1.0ml·min-1,柱温30℃。检测波长为230nm。结果:在浓度为(5.00～250.10)μg·mL-1范围内,本法线形关系良好,相关系数r=0.9997(n=8)。结论:该方法简单,准确,可以作为盐酸文拉法辛含量和有关物质的测定方法。
Objective: To establish a HPLC method for the determination of venlafaxine hydrochloride and related substances. Methods: C8 column, acetonitrile-0.3mol / L ammonium dihydrogen phosphate (40:60) was used as the mobile phase at a flow rate of 1.0ml · min-1 with a column temperature of 30 ℃. The detection wavelength is 230nm. Results: The linear relationship was good in the range of (5.00 ~ 250.10) μg · mL-1, the correlation coefficient was 0.9997 (n = 8). Conclusion: The method is simple and accurate and can be used as the determination of venlafaxine hydrochloride content and related substances.