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Stability of an oral liquid dosage form of glycopyrrolate prepared from tablets
1University of Houston, Houston, TX.
Abstract:
A stability-indicating assay method has been developed to quantify glycopyrrolate in an oral liquid dosage form. The developed method is accurate and precise and has a percent relative standard deviation of 1.8 based on 5 injections. The deomposition product and the excipients present in the dosage form did not interfere with the assay procedure. An oral liquid dosage form (0.5 mg/mL in water) that was prepared using 1-mg commercially available tablets was stable for 25 days (loss in potency, 8.2%). During that time, the pH value of the dosage form decreased from 6.8 to 6.6.
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