Assay Determination of Tranexamic acid in Pharmaceutical Dosage Form (Tablet) Using HPLC and ELS Detector
 
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1
Department of Chemical Technology, Dr. Babasaheb Ambedkar Marathwada University, Aurangabad- 431004 (MS), India
2
Wockhardt Research Centre, Aurangabad-431210 (MS), India
CORRESPONDING AUTHOR
Devanand B. Shinde   

Department of Chemical Technology, Dr. Babasaheb Ambedkar Marathwada University, Aurangabad- 431004 (MS), India
Publication date: 2017-10-08
 
Eurasian J Anal Chem 2010;5(3):204–211
 
KEYWORDS
ABSTRACT
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 300C and detector drift tube temperature set at 970C, 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.
 
REFERENCES (14)
1.
The Merck index (2001) 13th ed., New Jersey USA.
 
2.
Boylan J F, Klinck J R, Sandier A N, Arellano R, Greig P D, Nierenberg H, Roger S L and Glynnix M F (1996) Tranexamic Acid Reduces Blood Loss, Transfusion Requirements and Coagulation Factor Use in Primary Orthotopic Liver Transplantation. Anesthesiology 85(5): 1043.
 
3.
Nilsson I M (1980) Clinical pharmacology of aminocaproic and tranexamic acids. J. Clin. Pathalol. 33: 41.
 
4.
Tampubolon H B, Sumarlik E, Yuwono M and Indrayanto G (2005) Densitometric Determination of Tranexamic Acid in Tablets: Validation of the Method. J. Liq. Chromatogr. Rel. Technol. 28: 3243.
 
5.
Mohmed M E and Aboul-Enein H Y (1984) Ultraviolet Spectrophotometric Determination of Primary Amine-Containing Drugs via Their Charge-Transfer Complexes with Tetracyanoethylene. J. Envim. Anal. Chem. 19: 19.
 
6.
Wahbi A A M, Lotfi E A and Aboul-Enain H Y (1984) Spectrophotometric determination of tranexamic acid with chloranil. Talanta 31: 77.
 
7.
Atmaca S (2007) Spectrophotometric and Spectrofluorimetric Methods for the Determination of Tranexamic Acid in Pharmaceutical Formulation. Chem. Pharm. Bull. 55: 364.
 
8.
Ansari T M, Raza A and Rehman A (2005) Spectrophotometric Determination of Tranexamic Acid in Pharmaceutical Bulk and Dosage Forms. J. Soc. Anal. Chem. 21: 1133.
 
9.
Chang Q, Yin O Q P and Chow M S S (2004) Liquid chromatography–tandem mass spectrometry method for the determination of tranexamic acid in human plasma. J. Chromatogr. B. 805: 275.
 
10.
Matsubayashi K, Kojima C and Tachizawa H (1988) Determination of tranexamic acid in human serum by high-performance liquid chromatography using selective precolumn derivatization with phenyl isothiocyanate. J. Chromatogr. 433: 225.
 
11.
Perez J F H, Heger M, Dekker H, Krabbe H, Lankelma J and Ariese F (2007) Determination of a prodrug of tranexamic acid in whole blood by reversed-phase liquid chromatography after pre-column derivatization with fluorescamine. J. Chromatogr. 1157: 142.
 
12.
Khuhawar M Y and Rind F M A (2001) HPLC determination of tranexamic acid in pharmaceutical preparations and blood. J. Chromatogr. 53: 709.
 
13.
Stolyhwo A, Colin H and Guiochon G (1983) Use of Light Scattering as a Detector principle in Liquid Chromatography. J. Liq. Chromatogr. 265: 1.
 
14.
Validation of analytical procedures: Text and Methodology. In ICH Harmonized Tripartite Guidelines (2005) Q2 (R1).
 
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