Gupta Vishnu D
Pharmaceutics Division, University of Houston, Houston, Texas.
Int J Pharm Compd. 2005 Sep-Oct;9(5):399-401.
The chemical stability of hydralazine hydrochloride (0.2 mg/mL) in 0.9% sodium chloride injection and in 5% dextrose injection stored in a polyvinylchloride bags at 25 deg C was studied 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 1.2. The excipients present in the injection did not interfere with the assay procedure. The products of decomposition separated from the intact drug. In 5% dextrose injection, the loss in potency was 5% after less than 1 hour of storage and more than 40% after 1 day of storage at room temperature. The pH value of the injection decreased from 4.0 to 3.6 after 1 day. In 0.9% sodium chloride injection, the loss in potency after 2 days of storage at room temperature was 8%, and the pH value had decreased from 4.9 to 4.1. The physical appearance of the injection did not change.
采用一种稳定性指示高效液相色谱测定法，研究了盐酸肼屈嗪（0.2毫克/毫升）在0.9%氯化钠注射液和5%葡萄糖注射液中，于25℃下储存在聚氯乙烯袋中的化学稳定性。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1.2。注射液中的辅料不干扰测定过程。分解产物与完整药物分离。在5%葡萄糖注射液中，室温下储存不到1小时后效价损失5%，储存1天后效价损失超过40%。1天后注射液的pH值从4.0降至3.6。在0.9%氯化钠注射液中，室温下储存2天后效价损失8%，pH值从4.9降至4.1。注射液的外观没有变化。
