Das Gupta V, Ghanekar A G
J Pharm Sci. 1978 Jun;67(6):889-91. doi: 10.1002/jps.2600670651.
Stability-indicating methods for the quantitative determination of spironolactone were developed. The methods are based on high-pressure liquid chromatography and a reaction with blue tetrazolium. Both methods are accurate, precise, and sensitive and gave excellent results with commercial tablets, including those containing hydrochlorothiazide in addition to spironolactone, The blue tetrazolium method cannot be used in the presence of high concentrations of either polyethylene glycols or water. Spironolactone decomposition in water or polyethylene glycol appears to follow pseudo-first-order kinetics. The decomposition constant at 65 degrees was 0.0253/day in water versus 0.115/day in polyethylene glycol ointment base USP.
已开发出用于螺内酯定量测定的稳定性指示方法。这些方法基于高压液相色谱法以及与蓝四氮唑的反应。两种方法都准确、精密且灵敏，并且在市售片剂上取得了优异的结果，包括那些除螺内酯外还含有氢氯噻嗪的片剂。在高浓度聚乙二醇或水存在的情况下，蓝四氮唑法无法使用。螺内酯在水或聚乙二醇中的分解似乎遵循准一级动力学。在65摄氏度时，在水中的分解常数为0.0253/天，而在聚乙二醇软膏基质USP中的分解常数为0.115/天。
