Study on stability of tinidazole and spironolactone cream
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摘要: 目的 研究替硝唑螺内酯乳膏的稳定性。 方法 采用HPLC法同时测定替硝唑螺内酯乳膏中替硝唑和螺内酯的含量,用加速试验和长期试验预测替硝唑螺内酯乳膏的有效期。 结果 替硝唑和螺内酯的含量均随时间延长逐渐下降,经过加速试验,6个月替硝唑下降了4.37%,螺内酯下降了3.10%;经过长期试验,12个月替硝唑下降了5.27%,螺内酯下降了3.73%,含量与其他各项指标均符合规定。 结论 替硝唑螺内酯乳膏的有效期可定为12个月。Abstract: Objective To study the stability of tinidazole and spironolactone cream. Methods The content of tinidazole and spironolactone in cream were determined simultaneously by HPLC, and the period of validity of tinidazole spironolactone cream was predicted by accelerated test and long term test predictive validity. Results The content of tinidazole and spironolactone were decreasing gradually with the increasing of prolonging of time. After accelerated test, 6 months of tinidazole dropped 4.37%.spironolactone dropped 3.10%.After long term test, 12 months of tinidazole dropped 5.27%, spironolactone dropped 3.73%.Content and other indicators were in line with the provision. Conclusion The validity period of tinidazole and spironolactone was 12 months.
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Key words:
- tinidazole and spironolactone cream /
- stability /
- HPLC /
- accelerated test /
- long term test
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