【摘要】 目的:建立测定格拉司琼贴片含量的HPLC法,并测定其体外释放度。方法:采用HPLC法测定格拉司琼的含量,色谱柱为Luna-CN柱(150 mm×4.6 mm,5μm),流动相为甲醇-乙酸铵缓冲液49∶51(用三乙胺和乙酸调pH至6.0),流速1.0 ml/min,检测波长302 nm,柱温30℃。结果:格拉司琼在0.267～66.80μg/ml范围内线性关系良好(r=0.999 9)。精密度和稳定性良好,高、中、低浓度(16.46、13.72和10.98μg/ml)的回收率分别为(99.03±0.54)%、(97.82±0.23)%和(100.11±0.43)%(n=3)。格拉司琼贴片在24 h内累积释放度为(90.52±2.14)%。结论:本研究建立的HPLC法重现性好,灵敏度高,专属性强,可用于格拉司琼贴片的质量控制。格拉司琼贴片体外释放行为良好。更多还原

【Abstract】 Objective: To establish a HPLC method for determination of the content of granisetron in patch,and to investigate its in vitro release characteristics.Methods: The separation of granisetron was performed on a Luna-CN column(150 mm×4.6 mm,5 μm) with column temperature at 30 ℃,and the mobile phase consisted of methanol-ammonium acetate buffer(49∶51) whose pH value was adjusted to 6.0 with triethylamine and acetic acid.The flow rate was 1.0 ml/min.The detecting wavelength was 302 nm.Results: The linear range of granisetron was 0.267-66.80 μg/ml(r=0.999 9).The average recovery rates of high,middle and low concentrations(16.46,13.72,10.98 μg/ml) were(99.03±0.54)%,(97.82±0.23)% and(100.11±0.43)%(n=3).The cumulative release amount of granisetron patch within 24 h was(90.52±2.14)%.Conclusion: The HPLC method can be used for the quality control of granisetron patch because of its accuracy,good reproducibility and high sensitivity.Granisetron is well released from the patch in vitro.更多还原