Gupta Vishnu D
Pharmaceutics Division, University of Houston, Houston, Texas.
Int J Pharm Compd. 2007 May-Jun;11(3):259-61.
The chemical stability of hydrocortisone in an oral liquid dosage form without suspending agents was studied by using a stability-indicating high-performance liquid chromatographic assay method that was developed in our laboratory. The concentrations of the drug (range tested, 12 to 22 micrograms/mL) were related directly to peak heights and the percent relative standard deviation based on five injections was 0.8. The products of decomposition and excipients present in the dosage forms did not interfere with the developed assay method. The developed dosage form was almost uniform, with an intraday percent relative standard deviation based on five injections of 2.5, and the 5-day interday percent relative standard deviation was 2.8. The mixture was stable for at least 60 days when stored in amber-colored glass bottles at room temperature. The pH value of the mixture remained constant at 4.6 after 60 days of storage, and the physical appearance of the formulation did not change during the study period.
采用本实验室开发的稳定性指示高效液相色谱测定法，研究了不含悬浮剂的氢化可的松口服液体制剂的化学稳定性。药物浓度（测试范围为12至22微克/毫升）与峰高直接相关，基于五次进样的相对标准偏差百分比为0.8。剂型中存在的分解产物和辅料不干扰所开发的测定方法。所开发的剂型几乎均匀，基于五次进样的日内相对标准偏差百分比为2.5，五天日间相对标准偏差为2.8。当在室温下储存在琥珀色玻璃瓶中时，混合物至少稳定60天。储存60天后，混合物的pH值保持在4.6不变，并且在研究期间制剂的物理外观没有变化。
