Gupta Vishnu D
Pharmaceutics Division, University of Houston, Houston, Texas.
Int J Pharm Compd. 2007 Jul-Aug;11(4):347-8.
The chemical stability of cyproheptadine hydrochloride in an oral liquid dosage form was studied by using a stability-indicating high-performnace liquid chromatographic assay method that was developed in our laboratory. The concentrations of the drug were directly related to peak heights, with an R value of 0.991. The percent relative standard deviation based on five injections was 1.6. The products of decomposition and excipients present in the dosage forms did not interfere with the developed assay method. The mixture was stable for at least 180 days when stored in amber-colored glass bottles at room temperature. the pH value of the mixture remained constant at 3.7 after 180 days of storage, and the physical appearance of the formulation did not change during the study period.
采用本实验室建立的稳定性指示高效液相色谱测定法，对盐酸赛庚啶口服液剂型的化学稳定性进行了研究。药物浓度与峰高直接相关，R值为0.991。基于五次进样的相对标准偏差百分比为1.6。剂型中存在的分解产物和辅料不干扰所建立的测定方法。当在室温下储存在琥珀色玻璃瓶中时，该混合物至少稳定180天。储存180天后，混合物的pH值保持在3.7不变，并且在研究期间制剂的外观没有变化。
