Gupta Vishnu D
Pharmaceutics Division, University of Houston, Houston, TX.
Int J Pharm Compd. 2003 Jul-Aug;7(4):310-2.
The stability of cefuroxime sodium (50mg/mL) in 0.9% sodium chloride injection stored in polypropylene syringes was studied at 25 and 5 deg C by means of a stability-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 0.9. There were at least two products of decomposition that separated from the intact drug. The loss in potency was less than 10% after 2 days of storage at 25 deg C, and the loss in potency was less than 4% after 21 days of storage at 5 deg C. The pH vallue increased from 6.9 to 7.3 when the injection was stored at 25 deg C for 2 days, and the pH value increased from 6.9 to 7.0 when the injection was stored at 5 deg C for 21 days. The drug was not adsorbed onto the syringes. The intensity of the light-yellow color increased with the storage period at 25 deg C, but did not change signiificantly with storage at 5 deg C.
采用稳定性指示高效液相色谱测定法，研究了头孢呋辛钠（50mg/mL）在25℃和5℃下于聚丙烯注射器中储存于0.9%氯化钠注射液中的稳定性。药物浓度与峰高直接相关，基于五次进样的相对标准偏差百分比为0.9。至少有两种分解产物与未分解药物分离。在25℃储存2天后效价损失小于10%，在5℃储存21天后效价损失小于4%。注射液在25℃储存2天时pH值从6.9升至7.3，在5℃储存21天时pH值从6.9升至7.0。药物未吸附到注射器上。浅黄色的强度随在25℃下的储存时间增加，但在5℃下储存时无明显变化。
