Gupta Vishnu D
Pharmaceutics Division, University of Houston, Houston, Texas.
Int J Pharm Compd. 2004 Mar-Apr;8(2):153-5.
The chemical stability of phenylephrine hydrochloride (0.2 and 0.1 mg/mL) in 0.9% sodium chloride injection stored in polyvinyl chloride bags was studied at 25 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 1.0. The excipients present in the injection did not interfere with the assay procedure. The products of decomposition separated from the intact drug. At both concentrations (0.2 and 0.1 mg/mL), the loss in potency was less than 1.0% after 14 days of storage at room temperature. The pH value of the 0.2-mg/mL injection decreased from 4.3 to 4.0 after 14 days of storage, and the pH value of the 0.1-mg/mL injection decreased from 4.4 to 4.2.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25℃下储存于聚氯乙烯袋中的0.9%氯化钠注射液中盐酸去氧肾上腺素（0.2和0.1mg/mL）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1.0。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。在两种浓度（0.2和0.1mg/mL）下，室温储存14天后效力损失均小于1.0%。0.2mg/mL注射液储存14天后pH值从4.3降至4.0，0.1mg/mL注射液pH值从4.4降至4.2。注射液的外观未发生变化。
