多波长反相高效液相色谱法同时测定止血海绵中3种成分的含量

RP-HPLC determination of 3 components in hemostatic spongea under different UV wavelengths

目的:建立紫外-三波长反相高效液相色谱法测定止血海绵中3种有效成分地塞米松磷酸钠、替硝唑、克林霉素的含量。方法:色谱柱为 Discovery C_(18)柱(150mm×4.6 mm,5μm);流动相为乙腈-0.05 mol·L^(-1)磷酸二氢钾溶液-三乙胺(37:63:0.3),用磷酸调 pH 至5.3±0.05;流速1.0 mL·min^(-1);检测波长地塞米松磷酸钠为240nm,替硝唑为316 nm,克林霉素为210 nm。结果:被测3种成分在其各自最佳吸收波长处测定,可提高测定的灵敏度和准确度。地塞米松磷酸钠、替硝唑和克林霉素的平均回收率(n=15)分别为99.5%,98.9%,100.4%。结论:本法简便,结果准确,重复性好,专属性高,可作为该制剂的质控方法。

Objective： To establish an RP - HPLC method for determine of 3 components in hemostatic spongea under 3 different UV wavelengths. Methods：The column was Discovery C 18 （150 mm × 4. 6 mm,5 μm） ;The mobile phase was acetonitrile -0. 05 mol · L^- 1 potassium dihydrogen phosphate - triethylamine （37： 63 ： 0.3 ） , adjusted to pH 5.3 ± 0. 05 with phosphoric acid;The flow rate was 1.0 mL · min^-1. The detecting wavelengths was 240 nm for dexamethasone sodium phosphate, 316 nm for tinidazole and 210 nm for clidamycin. Results： The result showed that when determination was finished by RP - HPLC under the respective optimum wavelength, the 3 components in hemostatic spongea were precisely quantified. The average recoveries（ n = 15） of dexamethasone sodium phosphate, tinidazole, and clidamycin were 99.5% ,98.9% and 100. 4%, respectively. Conclusion：The proposed method is a simple, accurate, reproducible and credible quality control methed for the hemostatic spongea.