【摘要】 目的:建立同时测定复方螺内酯凝胶中螺内酯和红霉素含量的方法。方法:采用高效液相色谱法。色谱柱为Thermo-Hypersil ODS2-C18,流动相为0.1 mol/L磷酸二氢铵溶液(用三乙醇胺调节p H为7.0)-乙腈(60∶40,V/V),流速为1.0 ml/min,检测波长为215和238 nm,柱温为30℃,进样量为5μl。结果:螺内酯和红霉素的检测质量浓度分别在0.251 6~5.032 0、0.577 2~11.544 0μg/ml范围内与其峰面积呈良好的线性关系(r=0.999 9、0.999 9);精密度、稳定性、重复性试验的RSD≤0.83%;平均回收率分别为97.8%(RSD=0.74%,n=9)、96.7%(RSD=2.60%,n=9)。结论:本方法操作简便,重复性好,结果准确、可靠,可用于复方螺内酯凝胶的质量控制。更多还原

【Abstract】 OBJECTIVE:To establish a method for simultaneous determination of spironolactone and erythromycin in Compound spironolactone gel. METHODS:HPLC was performed on the column of Thermo-Hypersil ODS2-C18 with mobile phase of0.1 mol/L ammonium dihydrogen phosphate solution(p H was adjusted to 7.0 by triethylamine)-acetonitrile(60 ∶ 40,V/V)at flow rate of 1.0 ml/min,detection wavelength was 215 nm and 238 nm,column temperature was 30℃,and injection volume was 5 μl.RESULTS:The linear range was 0.251 6-5.032 μ g/ml for spironolactone and 0.577 2-11.544 μ g/ml(r=0.999 9)for erythromycin(r=0.999 9);RSDs of precision,stability and reproducibility tests were no more than 0.83%;average recoveries were 97.8%(RSD=0.74%,n=9)and 96.7%(RSD=2.60%,n=9),respectively. CONCLUSIONS:The method is simple,reproducible,accurate and reliable,and can be used for the quality control of Compound spironolactone gel.更多还原