Sunday , 16 May 2021

Analytical Method Development and Validation for the Simultaneous Estimation of Tranexamic acid and Ethamsylate by RP-HPLC Method in Bulk and Pharmaceutical Dosage Form

D. Sravanthi*, V. Pavan Kumar, M. Gobinath, V. Haribaskar, Ramesh Dhani, G. Kumari
Department of Pharmaceutical Analysis, Ratnam Institute of Pharmacy, Pidathapolur, Nellore, Andhra Pradesh, India

The chromatographic conditions were successfully developed for the separation of Tranaxamic acid and Ethamsylate by using Thermosil C18 column (4.6×100mm) 5µ, flow rate was 1ml/min, mobile phase ratio was Methanol: Phosphate buffer PH 3 (35:65 v/v), detection wavelength was 256 nm. The Spectroscopic method was done in solvent using methanol and the instrument used was WATERS HPLC Auto Sampler, Separation module 2695, photo diode array detector 996, Empower-software version-2. The retention times were found to be 2.466 mins and 4.337 mins. The % purity of Tranaxamic acid and Ethamysylate was found to be 99.83% and 98.89% respectively. The system suitability parameters for Tranaxamic acid and Ethamysylate such as theoretical plates and tailing factor were found to be 2095, 1.6 and 2766 and 1.2, the resolution was found to be 5.4. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study of Tranexamic acid and Ethamysylate was found in concentration range of 10µg-50µg and 60µg-300µg and correlation coefficient (r2) was found to be 0.999 and 0.999, % recovery was found to be 98.54% and 100.07%, %RSD for repeatability was 0.36 and 0.46, % RSD for intermediate precision was 0.1 and 0.1 respectively. The precision study was precision, robustness and repeatabilty.LOD value was 3.052 and 3.402 and LOQ value was 9.85 and 10.12 respectively.
Keywords: Tranexamic acid, Ethamsylate, HPLC

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