Improvement of Determination Method for Related Substance in Spironolactone Tablets

OBJECTIVE To improve the method for related substance determination and sample preparation of spironolactone tablets.METHODS The detection method was performed on the column of Welch Materials Eclipse XB-C₁₈column(4.6 mm×250 mm,5μm) with mobile phase of acetonitrile-water(54∶46) at flow rate of 1.0 mL·min^-1,detection wavelengths was 254 nm and 283 nm,column temperature was 35℃.The samples were extracted by flow phase ultrasonic method.RESULTS Related substances were completely separated from the principal component.The linear range of spironolactone and canrenone were 1.00-100.38μg·mL^-1 and 1.03-102.53μg·mL^-1(r=1.000),respectively.The average recovery rates were 99.52%and 99.23%,respectively.CONCLUSION The method is simple,accurate,reproducible and more convenient than the Chinese Pharmacopoeia method,which can provide reference for the optimization of the determination method of spironolactone tablets in the future.