Edition: BP 2025 (Ph. Eur. 11.6 update)
Action and use
Anticholinergic.
DEFINITION
Glycopyrronium Bromide Oral Solution is a solution of Glycopyrronium Bromide in a suitable flavoured vehicle.
The oral solution complies with the requirements stated under Oral Liquids and with the following requirements. Where appropriate, the oral solution also complies with the requirements stated under Unlicensed Medicines.
Content of glycopyrronium bromide, C19H28BrNO3
90.0 to 110.0% of the stated amount.
IDENTIFICATION
A. Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions in water.
(1) Dilute a volume of the oral solution, if necessary, to produce a solution containing 0.01% w/v of Glycopyrronium Bromide.
(2) 0.01% w/v of glycopyrronium bromide BPCRS.
(3) Equal volumes of solutions (1) and (2).
CHROMATOGRAPHIC CONDITIONS
(a) Use as the coating silica gel (Merck silica gel 60 plates are suitable).
(b) Use the mobile phase as described below.
(c) Apply 30 µL of each solution.
(d) Develop the plate to 15 cm.
(e) After removal of the plate, dry in air, spray with a solution containing 10 volumes of potassium iodide solution, 10 volumes of potassium iodobismuthate solution, 12 volumes of glacial acetic acid and 67 volumes of water.
MOBILE PHASE
20 volumes of glacial acetic acid, 20 volumes of water and 60 volumes of butan-1-ol.
SYSTEM SUITABILITY
The test is not valid unless the chromatogram obtained with solution (3) appears as a single, compact spot.
CONFIRMATION
The principal spot in the chromatogram obtained with solution (1) corresponds in position and colour to that in the chromatogram obtained with solution (2).
B. In the Assay, the retention time of the principal peak in the chromatogram obtained with solution (1) is similar to that of the principal peak in the chromatogram obtained with solution (2).
ASSAY
Carry out the method for liquid chromatography, Appendix III D, using the following solutions in the mobile phase.
(1) Dilute a quantity of the oral solution, if necessary, to produce a solution containing 0.01% w/v of Glycopyrronium Bromide.
(2) 0.01% w/v of glycopyrronium bromide BPCRS.
CHROMATOGRAPHIC CONDITIONS
(a) Use a stainless steel column (15 cm × 4.6 mm) packed with octadecylsilyl silica gel for chromatography (3 µm) (Inertsil ODS-3 is suitable).
(b) Use isocratic elution and the mobile phase described below.
(c) Use a flow rate of 1 mL per minute.
(d) Use an ambient column temperature.
(e) Use a detection wavelength of 215 nm.
(f) Inject 20 µL of each solution.
MOBILE PHASE
Dissolve 0.25 g of sodium heptanesulfonate in 615 mL of a 0.163% w/v solution of anhydrous sodium sulfate; add 3 mL of a 0.515% w/v solution of sulfuric acid, 150 mL of methanol R2 and 235 mL of acetonitrile R1.
SYSTEM SUITABILITY
The Assay is not valid unless the symmetry factor of the principal peak in the chromatogram obtained with solution (2) is between 0.8 and 2.0.
DETERMINATION OF CONTENT
Calculate the content of C19H28BrNO3 in the oral solution using the declared content of C19H28BrNO3 in glycopyrronium bromide BPCRS.
STORAGE
Glycopyrronium Bromide Oral Solution should be protected from light.
