Assay Determination of Tranexamic acid in Pharmaceutical Dosage Form (Tablet) Using HPLC and ELS Detector
Keywords:
ELS detector; Tranexamic acid; Pharmaceutical preparations; ValidationAbstract
A simple, rapid, and precise method is developed for the assay determination of tranexamic acid (Tr)
in pharmaceutical dosage form. The method was developed with HPLC, ELS detector and Alltima
cyano 100A (250 x 4.6 mm, 5µ) column, the mobile phase composed of aqueous solution of 0.05%
v/v trifluoroacetic acid and acetonitrile (60:40 v/v, pH 2.85). The instrumental settings are flow rate of
0.5 mL min-1, column temperature at 300
C and detector drift tube temperature set at 970
C, a detector
nitrogen gas flow set at 2.6 SLPM, gain 1 and 5 µL sample injection volume. Theoretical plates were
20007. Tailing factor was 1.38. The described method shows excellent linearity over a range of 50 to
150% of assay concentration. The correlation coefficient was 0.9987. The relative standard deviation
of six measurements for peak area and retention time less than 2% and 0.5% respectively. The
proposed method was found to be suitable and accurate for assay determination of Tr in
pharmaceutical preparations.