Friday , 19 July 2024

Analytical Method Development and Validation for Tranexamic Acid and Ethamsylate in Combined Dosage Form by RP-HPLC

1V. Bhavani*, 2Priyanka K
Department of Pharmaceutical Analysis, Smt. Sarojini Ramulamma College of Pharmacy, Sheshadrinagar, Mahabubnagar, Telangana, India.

A new method was established for simultaneous estimation of Tranexamic acid and Ethamsylate   by RP-HPLC method.  The chromatographic conditions were successfully developed for the separation of Tranexamic acid and Ethamsylate by using Inertsil C18 5µm (4.6*250mm) column, flow rate was 1ml/min, mobile phase ratio was Phosphate buffer (0.05M) pH 3: MEOH   (30:70%v/v)   (pH   was   adjusted   with   orthophosphoric   acid), detection wave length was 240nm. The instrument used was WATERS HPLC Auto Sampler, Separation module 2695, PDA Detector 996, Empower-software version-2. The % purity of Tranexamic acid and Ethamsylate was found to be 98.95% and 100.25% respectively. The system suitability parameters for  Tranexamic acid and Ethamsylate such as tailing factor and theoretical plates were found to be 1.2, 4683.4 and 1.3, 6490.3 the resolution was found to be 6.0. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study for Tranexamic acid and Ethamsylate was found in   concentration   range   of   50μg-450μg and correlation coefficient (r2) was found to be 0.998 and 0.997.  % mean recovery was found to be 100.53 and 99.88.  %RSD for repeatability was 0.5 and 0.3 and %RSD for intermediate precision was 0.2 and 0.1 respectively.  The precision study was precise, robust, and repeatable. LOD value was 2.8 and 0.2 and LOQ value was 10.01 and 10.3 respectively. Hence the suggested RP-HPLC method can be used for routine analysis of Tranexamic acid and Ethamsylate in API and Pharmaceutical dosage form.
Keywords: Inertsil C18, Ethamsylate and Tranexamic acid RP-HPLC.

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