【摘要】 目的建立高效液相色谱法测定帕利哌酮棕榈酸酯有关物质含量的方法。方法采用Phenomenex Luna（2）C₁₈色谱柱（250 mm×4.6 mm,5μm）,流动相A为10 mmol·L^-1的醋酸铵溶液,流动相B为甲醇-乙腈体积比为1∶1,流速为1.0 m L·min^-1,梯度洗脱,检测波长为280 nm,进样量为20μL,柱温为35℃。结果帕利哌酮棕榈酸酯与各有关物质均能满足分离要求;有关物质A^J均在质量浓度0.4².0 mg·L^-1内线性关系良好,相关系数r≥0.998 2（n=6）;有关物质A^J的平均回收率分别为91.8%、100.3%、100.2%、102.0%、96.4%、101.1%、104.8%、98.2%、102.7%和103.6%。结论本方法可作为帕利哌酮棕榈酸酯有关物质的测定方法。更多还原

【Abstract】 Objective To develop an HPLC method for the determination of related substances in paliperidone palmitate. Methods The separation was performed on a Phenomenex Luna（ 2） C₁₈ column（ 250 mm × 4. 6 mm,5 μm） with mobile phase a consisted of 10 mmol·L^-1 ammonium acetate and mobile phase B consisted of methanol-acetonitrile（ V ∶ V = 1∶ 1）. The flow rate was 1. 0 mL·min^-1 using gradient elution. The detect wavelength was 280 nm and sample size was 20 μL,and the column temperature was set at 35 ℃. Results Paliperidone palmitate could be effectively separated with related substances. The linear range of its related substances A-J was 0. 4-2. 0 mg·L^-1,r ≥0. 998 2（ n = 6）. The average recoveries of impurities A-J were 91. 8%,100. 3%,100. 2%,102. 0%,96. 4%,101. 1%,104. 8%,98. 2%,102. 7%,103. 6%, respectively. Conclusions The method is specific and sensitive,which can be used for the determination of the related substances in paliperidone palmitate.更多还原