QUANTITATION OF SPIRONOLACTONE IN THE PRESENCE OF CANRENONE USING HIGH-PERFORMANCE LIQUID-CHROMATOGRAPHY

Two stability-indicating high-performance liquid chromatography methods have been developed to quantify spironolactone in the presence of its product(s) of decomposition. Both methods are accurate and precise with percent relative standard deviation of 0.7 based on 5 readings using microC-18 column and 0.9 using microphenyl column. By using different wavelengths, the sensitivity of the methods to quantify spironolactone or canrenone (the major product of decomposition of spironolactone) can be increased many times. Spironolactone appears to be relatively stable between pH values of about 3.4-5.2. In the acidic pH, the decomposition is slower than on the basic side of the pH. Even at pH 7.3, the decomposition was about 3.1 times faster than at pH 2.3.