HPLC法测定氨苄西林胶囊溶出度Determination of ampicillin capsule dissolution by HPLC
王玥,刘俊华
Wang Yue;Liu Junhua(Zhuhai United Laboratories Zhongshan Branch;
摘要(Abstract)：
目的 建立氨苄西林胶囊的溶出度检测方法 ,以控制产品质量。方法 采用水为溶出介质 ,照高效液相色谱法 ,用Allti ma -C18( 4 .6mm× 2 5 0mm ,5 μm)柱 ,以水 -乙腈 - 1mol/L磷酸二氢钾溶液 - 1mol/L醋酸溶液 ( 90 9∶80∶10 ∶1)为流动相 ,检测波长 2 5 4nm ,流速 1.0ml/min的条件来检测溶出度。结果 氨苄西林在浓度为 0 .0 35～ 0 .4 36 g/L范围内线性关系良好 (r=1.0 0 0 0 ) ;平均回收率为 99.2 % ,RSD为 0 .4 9% (n =9)。 3批样品有较好的均一性 ,溶出度平均值为 99.5 %。结论 方法简便 ,准确度高 ,能较好地控制产品质量
Objective The HPLC analytical method was developed for the determination of ampicillin capsule dissolution to control the product quality. Methods In the HPLC method, water as the dissolution medium, Alltima C 18 (4.6mm×250mm,5μm) as the column and water-acetonitrile-1mol/L monobasic potassium phosphate-1mol/L acetic acid (909 ∶80∶10∶ 1) as the mobile phase were adopted. The wavelength of detection was 254 nm and the flow rate was 1.0 ml per minute. Results Good linear relations was achieved when the sample concentration was at the range of 0.035～0.436g/L ( r =1.0000). The average recovery was 99.2%, RSD was 0.49% ( n =9). The uniformity of three batches was acceptable and the average dissolution was 99.5%. Conclusion The method is simple, rapid and reliable, which can control the product quality effectively.
关键词(KeyWords)：
氨苄西林;胶囊;溶出度;HPLC
ampicillin; capsule; dissolution;HPLC
基金项目(Foundation):
作者(Authors):
王玥,刘俊华
Wang Yue;Liu Junhua(Zhuhai United Laboratories Zhongshan Branch;