Gupta Vishnu D
Pharmaceutics Division, University of Houston, Houston, Texas.
Int J Pharm Compd. 2006 May-Jun;10(3):237-9.
The stability of diphenhydramine hydrochloride (from an elixir) and lidocaine hydrochloride (from a viscous solution) in a mixture (1:1) was studied using a stability-indicating high-peformance liquid chromatographic assay method. The concentrations of the drugs were related directly to peak heights and the percent relative standard deviations based on five injections were 1.4 for diphenhydramine and 1.3 for lidocaine. The products of hydrolysis from the both the drugs and a number of excipients present in the dosage forms did not interfere with the developed assay procedure. The mixture was stable for at least 21 days when stored in amber-colored bottles at room temperature. The pH value of the mixture remained constant, and the physical appearance did not change during the study period.
采用稳定性指示高效液相色谱法研究了盐酸苯海拉明（来自酏剂）和盐酸利多卡因（来自粘性溶液）在混合物（1:1）中的稳定性。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，盐酸苯海拉明为1.4，盐酸利多卡因为1.3。两种药物以及剂型中存在的多种辅料的水解产物均不干扰所建立的分析方法。该混合物在室温下储存在琥珀色瓶中时至少稳定21天。在研究期间，混合物的pH值保持恒定，外观未发生变化。
