Gupta V Das
Pharmaceutics Division, University of Houston, Houston, TX.
Int J Pharm Compd. 2002 May-Jun;6(3):234-6.
A stability-indicating high-performance liquid chromatographic assay method was used to study the stability of cefotaxime sodium (50 mg/mL) in 0.9% sodium chloride injection in polypropylene syringes at 5 deg C and 25 deg C. The concentrations of the drug were directly related to peak heights, and the percent relative standard deviation based on 5 injections was 1.1. There were at least three products of decomposition that separated from the intact drug. At 5 deg C, the decomposition was less than 3% when stored for 18 days, and at 25 deg C, the loss in potency was less than 10% after 1 day of storage. When stored for 18 days at 5 deg C, the pH value of the injection decreased from 5.3 to 5.0 when stored at 25 deg C for 1 day. The drug was not absorbed onto the syringes, and the intensity of the light yellow color did not change significantly during storage at 5 deg C but increased during storage at 25 deg C.
采用一种稳定性指示高效液相色谱测定法，研究了头孢噻肟钠（50mg/mL）在5℃和25℃条件下于聚丙烯注射器中0.9%氯化钠注射液中的稳定性。药物浓度与峰高直接相关，基于5次进样的相对标准偏差百分比为1.1。至少有三种分解产物与未分解药物分离。在5℃下储存18天，分解率小于3%；在25℃下储存1天，效价损失小于10%。在5℃下储存18天，注射液的pH值从5.3降至5.0；在25℃下储存1天。药物未吸附到注射器上，浅黄色的强度在5℃储存期间无明显变化，但在25℃储存期间增加。
