NOTE: This monograph has been developed to cover unlicensed formulations.
Action and use
Antifibrinolytic.
DEFINITION
Tranexamic Acid Oral Solution contains Tranexamic Acid in a suitable 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 tranexamic acid, C8H15NO2
95.0 to 105.0% of the stated amount.
IDENTIFICATION
To a volume of the oral solution containing 0.25 g of Tranexamic Acid add 25 mL of ethanol (96%) and shake mechanically for 15 minutes; a cloudy white solution is produced, which may contain white lumps. Remove any lumps and filter the remaining solution using a glass fibre filter (Whatman GF/C filter is suitable). Wash the residue with 50 mL of ethanol (96%) and dry under vacuum at 35° for 30 minutes. The infrared absorption spectrum of the dried residue, Appendix II A, is concordant with the reference spectrum of tranexamic acid (RS 344).
ASSAY
Carry out the method for liquid chromatography, Appendix III D, using the following solutions in water.
(1) Dilute the oral solution to contain 0.05% w/v of Tranexamic Acid.
(2) 0.05% w/v of tranexamic acid BPCRS.
CHROMATOGRAPHIC CONDITIONS
(a) Use a stainless steel column (25 cm × 4.6 mm) packed with octadecylsilyl silica gel for chromatography (5 μm) (Hypersil ODS or Luna C18 (2) are suitable).
(b) Use isocratic elution and the mobile phase described below.
(c) Use a flow rate of 0.9 mL per minute.
(d) Use a column temperature of 30°.
(e) Use a detection wavelength of 220 nm.
(f) Inject 20 μL of each solution.
MOBILE PHASE
Dissolve 11.0 g of anhydrous sodium dihydrogen orthophosphate in 500 mL of water, add 5 mL of triethylamine and 1.4 g of sodium dodecyl sulfate, adjust the pH to 2.5 with 2M orthophosphoric acid and add sufficient water to produce 600 mL.
Add 400 mL of methanol and mix.
When the chromatograms are recorded under the prescribed conditions, the retention time of tranexamic acid is about 12 minutes.
DETERMINATION OF CONTENT
Calculate the content of C8H15NO2 in the oral solution using the declared content of C8H15NO2 in tranexamic acid BPCRS.
STORAGE
Tranexamic Acid Oral Solution should not be refrigerated.
