Фармацевтика Аналитика Акта

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Improved Rp- Hplc Method for the Simultaneous Estimation of Tranexamic Acid and Mefenamic Acid in Tablet Dosage Form

Subramanian Natesan, Devipriyadharshini Thanasekaran, Venkateshwaran Krishnaswami and Chandrasekar Ponnusamy

An improved derivatized RP- HPLC method with PDA detection has been developed and validated for the simultaneous estimation of tranexamic acid and mefenamic acid in combined tablet dosage form. The method employs precolumn derivatization using 0.2% methanolic ninhydrin at primary amino group of tranexamic acid to form ruhemann purple product. Mefenamic acid could not react with ninhydrin. The chromatographic estimation was achieved using phenomenex C- 18 (250 X 4.6 mm, 5 μm) analytical column and the mobile phase consisting of methanol and 20 mmol -1 acetate buffer (75:25, v/v) pH adjusted to 4.0 using ortho phosphoric acid at a flow rate of 1.0 mLmin -1 . The UV detection was carried out at 370 nm using photodiode array detector. The retention time of tranexamic acid and mefenamic acid were found to be 3.9 and 12.4 min. Tranexamic acid and mefenamic acid calibration curves were linear with correlation coefficient of 0.9973 and 0.9985 at a concentration ranging from 5μgmL -1 to 25 μgmL -1 . Recovery was between 98.5%- 100.5% for tranexamic acid and 99.7%- 104.3% for mefenamic acid. Limit of detection and quantification were 54.0ngmL -1 and 62.6 ngmL -1 for tranexamic acid, 12.3ngmL -1 and 37.1 ngmL -1 for mefenamic acid. The developed method is very sensitive as both peaks were well separated from its derivatizing agent peak with a short analysis time of 15 minutes.