Study On Tranexamic Acid Related Substance Analysis Method And Content Determination

Objective To design the controlling method of related substance of 2010 edition CH.P in Tranexamic Acid, to establish the RP-HPLC chromatographic condition. To separate the impurities from Tranexamic Acid,and analyze the separated impurities and confirm reliability and robustness of the method by precision test and linearity test . After establishing the method, analyze the sample from manufacturer to validate the applicability of the method.Method Based on the analysis of reported references, a RP-HPLC analysis method was designed and the RP-HPLC condition was optimized, including chromatographic column and mobile phase. Methodology validation was performed to confirm the feasibility and reliability of the established HPLC method.Results1. Diamonsil TM C18 column(5μm, 4.6mm×250mm) was used. The mobile phase was pH2.5 phosphate buffer solution (takes the 11.0g anhydrous sodium dihydrogen phosphate, dissolves in the 500ml water, adds the 5ml triethylamine and 1.4g lauryl sodium sulfate, adjusts the pH value with thin phosphoric acid to 2.5, dilutes by water to 600ml, namely) - methyl alcohol (60:40). The detection wave length was set at 220nm. The flow rate was 1.0ml/min. Specimen handling quantity: 20μl; The column temperature was 30℃.2. Related substances and tranexamic acid could be separated well. Additives did not interfere with the quantitation of related substances in tranexamic acid injection, The LOQ was 5.2 ng ,10.4 ng , and 200ng.3. Assaying of tranexamic acid was carried out with high performance liquid chromatography which was validated. and the contents of nine batches samles were all qualified (93.0%～107.0% of signal quantity ). Its linear range was0.515mg/ml～4.12mg/ml , and the average recovery was 99.91%,99.98%,100.01 % , RSD=0.05%(n=9).Conclusion The established method could not only be used to analyze the content of major component in tranexamic acid, but to control the contents of impurities in the products. This method is simple, rapid and accurate, and can fulfill the requirement of quality control.