Stability of oral liquid dosage forms of glycopyrrolate prepared with the use of powder

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.