论文部分内容阅读
目的:改进琥乙红霉素片剂含量的测定方法。方法:采用高效液相色谱法,以Waters XBridgeTMShied C18(250 mm×4.6 mm,5μm)为色谱柱;0.067 mol.L-1磷酸二氢铵溶液(用三乙胺调节pH至6.5)-乙睛(65∶35)为流动相;检测波长210nm;流速为1.0 ml.min-1;柱温为20℃。结果:红霉素A在39.83～139.41μg.ml-1范围内呈良好的线性关系(r=0.999 3),平均回收率为98.6%(RSD=0.9%,n=9),检测限为1.19μg,定量限为3.58μg。将该法测定结果与效价法测定的含量进行比较,结果基本一致。结论:该方法更简便、准确,重复性好。
Objective: To improve the determination of erythromycin ethylsuccinate tablets. METHODS: High performance liquid chromatography (HPLC) was performed on a Waters XBridge TLC C18 (250 mm × 4.6 mm, 5 μm) column. Ammonium dihydrogen phosphate solution (0.067 mol·L -1, adjusted to pH 6.5 with triethylamine) (65:35) as the mobile phase. The detection wavelength was 210 nm. The flow rate was 1.0 ml.min-1. The column temperature was 20 ℃. RESULTS: Erythromycin A showed a good linearity (r = 0.999 3) in the range of 39.83-139.41 μg.ml-1 with an average recovery of 98.6% (RSD = 0.9%, n = 9) and a detection limit of 1.19 μg, the limit of quantification is 3.58μg. The results of the method and the potency method to determine the content of the comparison, the results are basically the same. Conclusion: This method is simple, accurate and reproducible.