Anumolu Panukumar Durga, Gurrala Sunitha, Venkata Satya Subrahmanyam Chavali, Polisetty Santoshi Vani, Ravindran Anjana, Achanta Radhagayathri
Osmania University, Gokaraju Rangaraju College of Pharmacy, Department of Pharmaceutical Analysis, Hyderabad, India.
Turk J Pharm Sci. 2019 Mar;16(1):62-68. doi: 10.4274/tjps.77698. Epub 2018 Dec 31.
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 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 (f) values are low (12-16%), and similarity (f) 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 (λ 281 nm and 296 nm, respectively, for atorvastatin and fenofibrate) in acetate buffer, pH 2.8 solution.
如今，市场上充斥着各种剂型的复方药物，但缺乏对其进行定量的官方方法。为简化质量控制检测，首选一种用于分析复方剂型的单一溶出度测试方法。
如果所开发的溶出介质模拟了具有有限药物水溶性的药品的生物相关且具有区分性的溶出程序，那么它就是预测制剂行为的有用工具。
使用桨式美国药典溶出度测定仪，在900 mL介质中，转速为50 rpm，温度为37±0.5°C的条件下，对阿托伐他汀和非诺贝特胶囊的溶出曲线进行了评估。最佳介质是900 mL的0.5% w/v十二烷基硫酸钠。市售片剂在45分钟内累积溶出百分比超过85%。所提出的溶出度测试条件具有区分能力，差异因子（f）值较低（12 - 16%），相似性（f）因子值也较低（45 - 48%）。因此，使用0.5% w/v十二烷基硫酸钠溶液是合理的。
溶出度方法经验证（相对标准偏差<2%）。为同时对两种药物进行定量，在pH 2.8的醋酸盐缓冲溶液中建立了二阶导数分光光度法（阿托伐他汀和非诺贝特分别在281 nm和296 nm波长处）。
