论文部分内容阅读
目的:建立壳聚糖止血海绵中地塞米松磷酸钠、替硝唑及克林霉素的RP-HPLC含量测定方法。方法:色谱柱为Dis- covery C18柱(150 mm×4．6 mm,5μm);流动相为乙腈-0．05 mol·L-1磷酸二氢钾缓冲液-三乙胺(35:65:0．3),用磷酸调pH至5．3;流速1．0 ml·min-1;检测波长210 nm。结果:地塞米松磷酸钠、替硝唑、克林霉素分别在2-10μg·ml-1(r=0．999 7)、6 -30μg·ml-1(r=0．999 8)、30-150μg·ml-1(r=0．999 8)线性范围内呈现良好的线性关系。3组分的平均回收率分别为99．4％(RSD=2．1％);98．7％(RSD=1．7％)、99．2％(RSD=1．9％)。结论:本法操作简便、快速、结果准确。可作为该制剂的质控方法。
Objective: To establish a RP-HPLC method for determination of dexamethasone sodium phosphate, tinidazole and clindamycin in chitosan hemostatic sponge. METHODS: The column was Discolove C18 column (150 mm × 4.6 mm, 5 μm). The mobile phase was acetonitrile-0.05 mol·L-1 potassium dihydrogen phosphate buffer-triethylamine (35:65: 0.3), adjusted to pH 5.3 with phosphoric acid; flow rate 1.0 ml · min-1; detection wavelength 210 nm. Results: Dexamethasone sodium phosphate, tinidazole and clindamycin were respectively in the range of 2-10μg · ml-1 (r = 0.999 7), 6-30μg · ml-1 (r = 0.999 8) The linear range of 30-150μg · ml-1 (r = 0.999 8) showed a good linear relationship. The average recoveries of the three components were 99.4% (RSD = 2.1%), 98.7% (RSD = 1.7%) and 99.2% (RSD = 1.9%), respectively. Conclusion: This method is simple, fast and accurate. Can be used as a quality control method of the preparation.