Gupta Vishnu D
Pharmaceutics Division, University of Houston, Houston, Texas.
Int J Pharm Compd. 2009 Sep-Oct;11(5):445-6.
The chemical stability of amitriptyline hydrochloride in two oral liquid dosage forms has been studied 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, with an R value of 0.999. The percent relative standard deviation based on five injections was 1.0. The products of decomposition and excipients present in the dosage forms did not interfere with the developed assay method. The formulation which contained edetate disodium was stable for at least 37 days when stored in amber-colored glass bottles at room temperature. However, the pH value of this formulation decreased from 5.0 to 4.0 after 37 days of storage. The formulation without edetate disodium was stable for only 21 days (borderline) under the same storage conditions. The pH value of this formulation remained constant at 5 after 37 days of storage at room temperature and the physical appearance of both formulations did not change.
采用我们实验室开发的稳定性指示高效液相色谱测定法，研究了两种口服液体剂型中盐酸阿米替林的化学稳定性。药物浓度与峰高直接相关，R值为0.999。基于五次进样的相对标准偏差百分比为1.0。剂型中存在的分解产物和辅料不干扰所开发的测定方法。含有乙二胺四乙酸二钠的制剂在室温下储存在琥珀色玻璃瓶中时，至少37天是稳定的。然而，该制剂储存37天后pH值从5.0降至4.0。在相同储存条件下，不含乙二胺四乙酸二钠的制剂仅稳定21天（临界值）。该制剂在室温下储存37天后pH值保持在5不变，两种制剂的外观均未改变。
