Stability of spironolactone in an extemporaneously prepared suspension at two temperatures.
OBJECTIVE
To determine the stability of spironolactone in an extemporaneously prepared suspension at 22 and 4 degrees C over a three-month storage period.


METHODS
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.
Nahata
M C
MC
College of Pharmacy, Ohio State University, Columbus 43210.
Morosco
R S
RS
Hipple
T F
TF
D002266:Carboxymethylcellulose Sodium; D002851:Chromatography, High Pressure Liquid; D004355:Drug Stability; D004356:Drug Storage; D006801:Humans; D006863:Hydrogen-Ion Concentration; D013148:Spironolactone / Q000737:chemistry*; D013535:Suspensions; D013696:Temperature; D013997:Time Factors
D013535:Suspensions; D013148:Spironolactone; D002266:Carboxymethylcellulose Sodium