Tranexamic Acid

Physical Appearance :

Tranexamic Acid occurs as white, crystals or crystalline powder. It belongs to antifibrinolytic family.

Tranexamic Acid, when dried, contains not less than 98.0% and not more than 101.0% of tranexamic acid (C8H15NO2)

Structural formula:

 

Tranexamic Acid
Tranexamic Acid

Chemical Formula

(C8H15NO2).

Solubility:

It is freely soluble in water, and practically insoluble in ethanol (99.5).

Identification : BY FTIR

Determine the infrared absorption spectrum of Tranexamic Acid as directed in the potassium bromide disk method under Infrared Spectrophotometry, and compare the spectrum with the Reference Spectrum or the spectrum of Tranexamic Acid RS: both spectra exhibit similar intensities of absorption at the same wave numbers.

pH:

The pH of a solution prepared by dissolving 1.0 g of Tranexamic Acid in 20 mL of water is between 7.0 and 8.0.

Color of solution:

Dissolve 1.0 g of Tranexamic Acid in 10 mL of water: the solution is clear and colorless.

LOD: (LOSS ON DRYING)

Not more than 0.5% (1 g, for 2 hours).

Residue on ignition :

Not more than 0.1%

ASSAY : ( HPLC-Method)

Mobile Phase:

Dissolve 11.0 g of anhydrous sodium dihydrogen phosphate in 500 mL of water, and add 5 mL of triethylamine and 1.4 g of sodium lauryl sulfate. Adjust the pH to 2.5 with phosphoric acid or diluted phosphoric acid (1 in 10), add water to make 600 mL, and add 400 mL of methanol.

Standard Preparation:

Weigh accurately about 50 mg of Tranexamic Acid RS, previously dried, dissolve in water to make exactly 25 mL, and use this solution as the standard solution.

Sample Preparation:

Weigh accurately about 50 mg of Tranexamic Acid, previously dried, dissolve in water to make exactly 25 mL, and use this solution as the sample solution.

Chromatographic conditions:

Sample Volume: 20µL
Detector: UV ʎmax=220nm
Column: A stainless steel column 6.0 mm in inside diameter and 25 cm in length, packed with octadecylsilanized silica gel for liquid chromatography (5 mm in particle diameter).
Column temperature: 25°C
Flow rate: Adjust so that the retention time of tranexamic acid is about 20 minutes.

Calculations:

Contents of Tranexamic acid can be calculated by given formula

%age Assay =   Hs/Ha × Ca/Cs × 100

Hs = Peak height ratio from the Sample solution

Ha = peak height ratio from the Standard solution

Ca = concentration of Alclometasone Dipropionate in the Standard solution (mg/ml)

Cs = concentration of the Sample solution (mg/ml)

Assay: (BY TITRATION) (non-aqueous )

Weigh accurately 10mg of tranexamic acid in a round 250ml conical flask and add 50ml of glacial acetic acid. Dissolve in magnetic stirrer. Now simply titrate it 0.1M perchloric acid. Each ml of 0.1M perchloric acid is equivalent to 15.72 mg of tranexamic acid.

Calculation:

Contents of Tranexamic acid can be calculated by given formula

%age of tranexamic acid = (volume of 0.1M perchloric acid × 15.72) ÷ weight of sample taken.

ALTERNATIVE METHOD:(BY UV/vis Spectrophotometer)

STANDARD PREPARATION:

Weigh accurately about 50mg of Tranexamic acid of working standard in to 50ml volumetric flask and dilute it with distilled water. Take 1ml of this solution and dilute upto 100ml with the same solvent.

SAMPLE PREPARATION:

Weigh accurately about 50mg of Tranexamic acid of sample in to 50ml volumetric flask and dilute it with distilled water. Take 1ml of this solution and dilute upto 100ml with the same solvent.

Take Reading at 210nm

Contents of Tranexamic acid can be calculated by given formula

%age of tranexamic acid= At/As × Cs/Ct × 100

At =  Absorbance Of  Tranexamic acid in Sample Solution.

As =  Absorbance Of  Tranexamic acid in Standard Solution.

Cs =  Concentration of standard solution (mg/ml)

Ct =  Concentration of sample solution (mg/ml)

Leave a Comment

%d bloggers like this: