Gupta Vishnu D, Sood Arun
Pharmaceutics Division, University of Houston.
Int J Pharm Compd. 2005 Mar-Apr;9(2):165-6.
The chemical stability of isoniazid in an oral liquid dosage form was studied by means of a specially developed stabilty-indicating high-performance liquid chromatographic assay method. The concentrations of the drug were directly related to peak heights, and the percent relative standard deviation based on five injections was 0.93. The products of decomposition and excipients present in the dosage forms did not interfere with the developed assay method. The preparation was stable for at least 42 days when stored in amber-colored glass bottles at room temperature. The pH value of the preparation decreased from 5.9 to 5.6 after 42 days of storage. The physical appearance of the preparation changed from almost colorless to light brown.
采用专门开发的稳定性指示高效液相色谱测定法，研究了异烟肼口服溶液剂型的化学稳定性。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0.93。剂型中存在的分解产物和辅料不干扰所开发的测定方法。当在室温下储存在琥珀色玻璃瓶中时，该制剂至少稳定42天。储存42天后，制剂的pH值从5.9降至5.6。制剂的外观从几乎无色变为浅棕色。
