Gupta Vishnu D
Pharmaceutics Division, University of Houston, Houston, Texas.
Int J Pharm Compd. 2008 Mar-Apr;12(2):161-2.
The chemical stability of tramadol hydrochloride injection was studied by using a stability-indicating high-performance liquid chromatographic assay method that was developed in our laboratory. The concentrations of the drug were related directly to peak heights, and the percent relative standard deviation based on five injections was 0.9. The products of decomposition and excipients present in the dosage form did not interfere with the developed assay method. The injection was stable for at least 42 days when stored in clear glass vials at room temperature. The pH value of the injection remained constant at 6.7 after 42 days of storage, and the physical appearance of the injection 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，对盐酸曲马多注射液的化学稳定性进行了研究。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0.9。剂型中存在的分解产物和辅料不干扰所建立的测定方法。该注射液在室温下储存在透明玻璃瓶中时，至少在42天内是稳定的。储存42天后，注射液的pH值保持在6.7不变，且在研究期间注射液的外观没有变化。
