Simultaneous Determination of Spironolactone and Erythromycin in Compound Spironolactone Gel by HPLC / 中国药房

ABSTRACT

OBJECTIVE:To establish a method for simultaneous determination of spironolactone and erythromycin in Com-pound spironolactone gel. METHODS:HPLC was performed on the column of Thermo-Hypersil ODS2-C18 with mobile phase of 0.1 mol/L ammonium dihydrogen phosphate solution (pH 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 μg/ml for spironolactone and 0.577 2-11.544 μg/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,ac-curate and reliable,and can be used for the quality control of Compound spironolactone gel.