摘要
目的建立测定利福布汀的HPLC方法,并测定市售胶囊制剂中利福布汀的含量。方法以Lichro-spher(100(RP-85.0μm×250mm)为分析柱,乙腈-甲醇-0.04mol/LKH2PO4(54:10:36,v/v)为流动相,流速1ml/min,柱温:40℃,进样量:5.0μl,254nm处紫外检测;对硝基苯酚为内标。结果利福布汀在3.75~150.00μg/ml范围内,峰面积对浓度呈良好的线性关系(r=0.99987),平均回收率为100.24%,RSD为0.90%(n=6)。结论本法简便、快速、准确、灵敏度高、重现性好,适用于利福布汀的质量控制和临床血药浓度的监测。
Objective To establish HPLC mathod for the content determination of rifabution. Methods Using p - nitrophenol as the internal standard, Lichrospher 100 ( RP - 8 5.0μm ×250mm) column was used and the mobile phase consisted of acetonitrile - methanol - 0. 04mol/L KH2PO4 (54 : 10 : 36, v/v) with the flow rate of 1.0ml/min. The column temperature was set at 40℃, the injection volume was 5. 0μl and the detection wavelength was 254nm. Results The linear range of rafibution was 3.75 - 150. 00μgomL - 1 (r = 0. 99987) with an average recovery of 100. 24% ( RSD = 0. 89%, n = 6). Conclusion The method is simple, rapid, accurate and sensitive for the content determination of rifabutin in the quality control and the clincal monitoring.
出处
《临床合理用药杂志》
2011年第05X期80-81,共2页
Chinese Journal of Clinical Rational Drug Use