摘要
目的：建立HPLC测定甲硝唑芬布芬缓释片中甲硝唑和芬布芬的含量方法。方法：采用高效液相色谱法，Diamonsil C18（250mm×4．6mm，5um）色谱柱，流动相为甲醇-0．075mol／LKH2PO4（2：1），检测波长为295nm，流速为0．8ml／min，进样量为20ul，柱温为室温。结果：甲硝唑在16～160ug／ml，芬布芬在12～120ug／ml范围内，其浓度与峰面积线性关系良好；高、中、低三个浓度的平均回收率均在100．0％±2％范围内，精密度的RSD均小于1％；两主药峰的分离度大于1．5。结论：本方法简便、快速、可靠，可用于甲硝唑和芬布芬的测定。
OBJECTIVE High performance liquid chromatography method was developed to determine content of Metronidazole and fenbufen in sustained -release tablets. METHODS The sample was determined by HPLC system, Diamonsil C18 （250 mm×4.6 ram,5 um）chromatography column,the mobile phase is methanol -0. 075 mol/L KH2PO4 （2：1 ） ,the detection wavelength is 295 nm, the flow rate is 0.8 ml/min, the column temperature is room temperature. RESULTS The linear range of Metronidazole was 16 - 160 ug/ml, The linear range of fenbufen was 12 - 120 ug/ml, the concentration and the peak area showed a good linear relationship; the average recovery of high,middle and low concentration were all in the rang of 100.0% ±2% ,the RSD of specificity were all lower than 1% ; the resolution of the two peaks which indicated the main drugs were higher than 1.5. CONCLUSION The method is simple,rapid and reliable, which is suitable for the determination of Metronidazole and fenbufen.
出处
《天津药学》
2008年第6期16-18,共3页
Tianjin Pharmacy
关键词
甲硝唑
芬布芬
缓释片
高效液相色谱法
metrenidazole, fenbufen, sustained - release tablet, HPLC
