Gupta Vishnu D
Pharmaceutics Division, University of Houston, Houston, TX.
Int J Pharm Compd. 2003 Sep-Oct;7(5):386-8.
A previously developed stability-indicating high-performance liquid chromatographic assay method was used to investigate the stability of glycopyrrolate in oral liquid dosage forms (0.5 mg/mL) that contained a 0.05-M phosphate buffer of pH 5.6 and either 10% sorbitol or 10% sucrose as the sweetening agent. The decomposition product and sorbitol or sucrose did not interfere with the assay procedure. The liquid dosage forms were prepared using commercially available powder. After 129 days of storage at 25 deg C, the loss in potency was less than 6%. The physical appearance of this dosage form did not change during the study period. The pH value of the dosage forms in sorbitol did not change from the original value of 5.6. The pH value of the dosage forms in sucrose decreased from 5.6 to 4.8 after 129 days of storage at 25 deg C.
采用先前开发的稳定性指示高效液相色谱测定法，研究了格隆溴铵在口服液体剂型（0.5mg/mL）中的稳定性，该剂型含有pH值为5.6的0.05M磷酸盐缓冲液以及10%山梨醇或10%蔗糖作为甜味剂。分解产物与山梨醇或蔗糖均不干扰测定过程。液体剂型使用市售粉末制备。在25℃储存129天后，效价损失小于6%。在研究期间，该剂型的外观未发生变化。含山梨醇剂型的pH值未从初始值5.6改变。含蔗糖剂型在25℃储存129天后，pH值从5.6降至4.8。
