Santoro M I, Hackmann E R, Borges V M
Departamento de Farmácia-Faculdade de Ciências Farmacêuticas, Universidade de São Paulo, Brasil.
Boll Chim Farm. 1992 Jun;131(6):226-9.
Shelf-lives of liquid pharmaceutical preparations (injectable and oral solution) containing phenobarbital sodium, commercially available in Brazil, were predicted by accelerated stability test using isothermal method (at 37 degrees C, 50 degrees C and 75 degrees C). Data obtained in high temperature studies using Arrhenius relation were applied to predict shelf-lives at room temperature. The shelf-lives were calculated by linear regression analysis. UV difference spectrophotometry was used for phenobarbital determination. Thin-layer chromatography was used for separation and identification of phenylethylacethylurea, the main degradation product of phenobarbital.
采用等温法(在37℃、50℃和75℃)加速稳定性试验,预测了巴西市场上含苯巴比妥钠的液体制剂(注射剂和口服溶液)的有效期。利用Arrhenius关系式,将高温研究获得的数据用于预测室温下的有效期。通过线性回归分析计算有效期。采用紫外差示分光光度法测定苯巴比妥。采用薄层色谱法分离和鉴定苯巴比妥的主要降解产物苯乙基乙酰脲。