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Stability of spironolactone in an extemporaneously prepared suspension at two temperatures
M C Nahata1, R S Morosco, T F Hipple
1College of Pharmacy, Ohio State University, Columbus 43210.
Objective:
To determine the stability of spironolactone in an extemporaneously prepared suspension at 22 and 4 degrees C over a three-month storage period.
Design:
Spironolactone suspension (1 mg/mL) was prepared in syrup NF, carboxymethylcellulose, and purified water USP. The suspension was stored in ten amber glass prescription bottles; five were stored at 22 degrees C and five at 4 degrees C. Samples were drawn from each bottle and analyzed in duplicate (n = 10) on days 0, 7, 14, 28, 42, 56, 70, and 91. Spironolactone concentrations were measured by a reproducible and stability-indicating HPLC method. Inspection of visual and pH changes also was performed on each study day.
Results:
The mean concentration of spironolactone was always higher than 98 percent of its initial concentration. The pH and appearance of the suspension did not change substantially.
Conclusions:
Spironolactone was stable in a suspension containing syrup, carboxymethylcellulose, and purified water for three months during storage in amber glass bottles at both 22 and 4 degrees C.