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目的:探讨高效液相色谱法测定罗红霉素胶囊中罗红霉素含量的可行性。方法:应用高效液相色谱法测定罗红霉素胶囊中罗红霉素的含量。色谱设置条件如下:ODSC18色谱柱:250mm×4.6mm,5um。流动相:选用浓度为0.1mol/L的磷酸二氢铵溶液,并使用三乙胺将PH调节至6.5。检测波长:210nm。柱温:25℃。流速:1.0ml/min。进样量:20ul。测定结束后,对所得数据进行回顾性的分析。结果:罗红霉素胶囊的进样量在15-80ug/mL范围内,进样量与峰面积之间存在良好的线性关系。回收率为99.57%,RSD=0.72%。结论:应用高效液相色谱法测定罗红霉素胶囊中罗红霉素的含量,具有操作简单、重现性好、测定数据可靠等优点,此方法的可行性较高,值得在临床上推广应用。
Objective: To investigate the feasibility of determination of roxithromycin in roxithromycin capsules by high performance liquid chromatography. Methods: The contents of roxithromycin in roxithromycin capsules were determined by high performance liquid chromatography. The chromatographic setup conditions are as follows: ODSC18 Column: 250 mm × 4.6 mm, 5 μm. Mobile phase: The concentration of 0.1mol / L of ammonium dihydrogen phosphate solution, and the use of triethylamine to adjust the pH to 6.5. Detection wavelength: 210nm. Column temperature: 25 ℃. Flow rate: 1.0 ml / min. Injection volume: 20ul. After the measurement was completed, the data obtained were retrospectively analyzed. Results: The injection volume of roxithromycin capsules was in the range of 15-80 ug / mL. There was a good linear relationship between injection volume and peak area. The recovery was 99.57% with RSD = 0.72%. Conclusion: The determination of roxithromycin in roxithromycin capsules by HPLC has the advantages of simple operation, good reproducibility and reliable measurement data. This method is more feasible and worthy of clinical application application.