Gupta Vishnu D
Pharmaceutics Division, University of Houston, Houston, Texas.
Int J Pharm Compd. 2009 Sep-Oct;11(5):438-9.
The chemical stability of scopolamine hydrobromide in nasal solution has been studied by using a stability-indicating high-performance liquid chromatographic assay method that was developed in our laboratory. The concentrations of the drug were directly related to peak heights, and the percent relative standard deviation based on five injections was 0.4. The products of decomposition and excipients present in the dosage forms did not interfere with the developed assay method. The nasal solution was stable for at least 42 days when stored in amber-colored glass bottles at room temperature. The physical appearance and the pH value of the nasal solution did not change during the study period.
采用在我们实验室开发的稳定性指示高效液相色谱测定法，研究了氢溴酸东莨菪碱在鼻腔溶液中的化学稳定性。药物浓度与峰高直接相关，基于五次进样的相对标准偏差百分比为0.4。剂型中存在的分解产物和辅料不干扰所开发的测定方法。鼻腔溶液在室温下储存在琥珀色玻璃瓶中时至少稳定42天。在研究期间，鼻腔溶液的外观和pH值没有变化。
