Stability of Oral Liquid Dosage Forms of Glycopyrrolate Prepared with the Use of Powder
Author(s): Gupta Vishnu D
Issue: Sep/Oct 2003 - After the Women's Health Initiative Trial
View All Articles in Issue
Page(s): 386-388
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Abstract: 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°C, the loss in potency was less than 6%. The physical
appearance of the dosage forms 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°C.
Related Keywords:
Glycopyrrolate, stability of oral liquid dosage forms
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