溶解
非诺贝特
色谱法
化学
溶解度
溶解试验
阿托伐他汀
十二烷基硫酸钠
剂型
药理学
有机化学
医学
生物制药分类系统
作者
Panukumar Durga Anumolu,Sunitha Gurrala,Subrahmanyam Chavali Venkata Satya,Santoshi Vani Polisetty,Anjana Ravindran,Radhagayathri Achanta
出处
期刊:Turkish journal of pharmaceutical sciences
[Galenos Yayinevi]
日期:2019-03-01
卷期号:16 (1): 62-68
被引量:5
摘要
Nowadays, the market is flooded with combinations of drugs in various dosage forms, but there is a lack of official methods to quantify them. A single dissolution test method for the analysis of combined dosage form is preferred for simplification of quality control testing.If the developed dissolution medium mimics the biorelevant and discriminating dissolution procedure for drug products with limited drug aqueous solubility it is a useful tool for qualitative forecasting of the in vivo behavior of formulations.Dissolution profiles were evaluated for atorvastatin and fenofibrate in capsules, using a paddle-type United States Pharmacopeia dissolution apparatus in 900 mL of medium at 50 rpm and 37±0.5°C. The best medium was 900 mL of 0.5% w/v sodium lauryl sulfate. The cumulative % dissolution was more than 85% within 45 min for marketed tablets. The proposed dissolution test conditions have discriminative power, dissimilarity factor (f1) values are low (12-16%), and similarity (f2) factor values are also low (45-48%). Hence the use of 0.5% w/v sodium lauryl sulfate solution is justified.The dissolution method was validated (% relative standard deviation <2). To quantify both drugs simultaneously, a second derivative spectrophotometric method was established (λmax 281 nm and 296 nm, respectively, for atorvastatin and fenofibrate) in acetate buffer, pH 2.8 solution.
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