【摘要】 目的建立用紫外可见分光光度计测定帕潘立酮棕榈酸酯长效纳米混悬注射剂的含量和体外释放度的方法。方法混悬液采用湿法研磨技术制备,含量测定溶液为四氢呋喃-N,N-二甲基甲酰胺（体积比5∶95）,释放介质为质量分数0.489%聚山梨醇酯20的1 mmol·L^-1盐酸溶液900 mL,检测波长为280 nm。结果在含量测定溶液中,帕潘立酮棕榈酸酯的质量浓度在20.0⁶0.0 mg·L^-1内与吸光度呈良好的线性关系,回归方程为A=1.36×10^-2 ρ+2.68×10^-2（r=0.999 9）,回收率在98%¹02%内,精密度的RSD均小于2%（n=6）;在释放介质中,帕潘立酮棕榈酸酯的质量浓度在6.0⁴0.0 mg·L^-1内与吸光度呈良好的线性关系,回归方程为A=1.45×10^-2ρ+9.1×10^-3（r=0.999 9）,帕潘立酮棕榈酸酯在释放介质中8 h内稳定。结论该方法操作简单快捷,准确性和重复性较好,可用于测定帕潘立酮棕榈酸酯制剂的含量和释放度。更多还原

【Abstract】 Objectives To establish UV methods for the determination of the content and release of paliperidone palmitate（PP） in suspension injection. Methods The suspension injection was prepared by wet milling. The diluent consisted of tetrahydrofuran and N,N-dimethyl formamide（V∶V=5∶95）. The dissolution medium was 1 mmol·L^-1 hydrochloric acid solution 900 m L with 0.489% polysorbate 20. The detection wavelength was set at 280 nm. Results Good linear relationship（r=0.999 9） between absorbance（A） and concentration（ρ） of PP in diluent ranging from 20.0 – 60.0 mg·L^-1 Pwas obtained, and the calibration curve was A=1.36×10^-2ρ + 2.68×10^-2（r= 0.999 9）. The solution stability of PP in diluent was good, and the recoveries of low, middle and high concentrations were in the range of 98% – 102%. The intra-day and inter-day RSDs were less than 2.0%. In the dissolution medium, good linear relationship（r=0.999 9） between absorbance（A） and concentration（ρ） of PP from 6.0 – 40.0 mg·L^-1 was obtained, and the calibration curve was A = 1.45×10^-2ρ + 9.1×10^-3（r=0.999 9）. Conclusions The solution stability of PP is good. The methods are accurate, simple, rapid and reproducible, and can be used for determination of content and release of PP in suspension injection.更多还原