Mehta A C, Hart-Davies S, Payne J, Lacey R W
Department of Pharmacy, General Infirmary, Leeds, U.K.
J Clin Pharm Ther. 1994 Oct;19(5):313-5. doi: 10.1111/j.1365-2710.1994.tb00818.x.
A study was carried out using high performance liquid chromatography (HPLC) to determine the chemical stability of amoxycillin and potassium clavulanate in 250/62 co-amoxyclav oral suspension (Augmentin), stored at room temperature (RT, 20 degrees C) and 8 degrees C over a period of 11 days. The suspension was judged to be acceptable if its components maintained at least 90% of their label concentrations. During the test period, the amoxycillin component was found to be more stable than the clavulanate. Amoxycillin was stable for 7 days at both temperatures. Potassium clavulanate maintained at least 90% of its initial concentration for 7 days at 8 degrees C but showed more than 40% degradation in the same time period at RT. For potassium clavulate the shelf-life, or time taken for the original concentration to drop to 90% of its value (t90) at RT was found to be 2 days.
进行了一项研究,使用高效液相色谱法(HPLC)来测定阿莫西林和克拉维酸钾在250/62复方阿莫西林克拉维酸口服混悬液(安灭菌)中的化学稳定性,该混悬液分别在室温(RT,20摄氏度)和8摄氏度下储存11天。如果其成分保持至少90%的标示浓度,则该混悬液被判定为合格。在测试期间,发现阿莫西林成分比克拉维酸更稳定。阿莫西林在两个温度下均能稳定7天。克拉维酸钾在8摄氏度下7天内保持至少90%的初始浓度,但在室温下同一时间段内降解超过40%。对于克拉维酸钾,在室温下的保质期,即原始浓度降至其值的90%(t90)所需的时间为2天。