摘要
目的:建立高效液相色谱法测定利福平胶囊溶出度。方法:采用AgilentC8色谱柱(4.6mm×250mm,5?m),流动相为甲醇-乙腈-0.075mol.L-1磷酸二氢钾溶液-1.0mol.L-1枸橼酸溶液(30:30:36:4),流速为1ml·min-1,检测波长254nm。结果:本方法测定利福平的线性范围为85.4～6.83μg.ml-1,r=0.9999,平均回收率为99.5%(RSD=0.5%,n=6),5批不同厂家的样品用该法测定溶出度均符合规定。结论:该质量标准的研究有效控制了利福平胶囊的质量,提高了方法的专属性,结果准确,灵敏度高。
Objective ：To establish an RP - HPLC method for inspect the Dissolution of Rifampicin capsule. Method ：The method was performed on a Agilent C8 column （ 4.6mm× 250mm, 5 μm） with a mobile phase of methanol - acetonltrile - 0. 075 mol. L - ^-1 Potassium dihydrogen phosphate - 1.0mol. L^-1 Citrate （ 30 ： 30 ： 36 ： 4 ）, flow rate ： 1ml min - 1, determination wavelength is 254nm. Results ：The linear range us 85.4 - 6.83μg. ml - 1, r = 0. 9999. The average recovery was 99.5 % （ RSD = 0.5 %, n = 6）. 5 batches of Rifampicin capsules from different contry were inspected and the Dissolution were all confit. Conclusion ： It can be good used for control- ling the qualitv of Rifamoicin cansule. The method is accurate and sensitive.
出处
《医学信息（中旬刊）》
2010年第12期3804-3805,共2页
Medical Information Operations Sciences Fascicule
