RP-HPLC ANALYSIS OF TRANEXAMIC ACID AND ETHAMSYLATE IN COMBINED DOSAGE FORM
A new method was established for simultaneous estimation of Ethamsylate and Tranexamic acid by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Ethamsylate and Tranexamic acid 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 Ethamsylate and Tranexamic acid was found to be 98.95% and 100.25% respectively. The system suitability parameters for Ethamsylate and Tranexamic acid such as theoretical plates and tailing factor were found to be 1.2, 4683.4 and 1.3, 6490.3 the resolution was found to be 8.0. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study for Ethamsylate and Tranexamic acid was found in concentration range of 100?g-500?g and 1?g-5?g and correlation coefficient (r2) was found to be 0.999 and 0.999, % mean recovery was found to be 99.88 and 100.53 %RSD for repeatability was.0.3 and 0.5, % 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 Ethamsylate and Tranexamic acid in API and Pharmaceutical dosage form
14 , 1 , 2024
1 - 8
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