Determination of Optical Isomers in Raltitrexed Raw Material by Modified HPLC / 中国药房

ABSTRACT

OBJECTIVE:To improve HPLC method for determining optical isomers in raltitrexed raw material.METHODS:After improved,the column was CHIRALPAK AD-H with mobile phase consisted of n-hexane-anhydrous ethanol-trifluoroacetate (70∶30∶0.1,V/V/V).The sample size was 100 μL.The flow rate of 1.0 mL/min.The detection wavelength was set at 226 rm,and column temperature was 35 ℃.RESULTS:The linear range of optical isomers was 99.68-398.7 ng(r=0.999 9).The quantitation limit was 4.945 ng,and detection limit was 1.648 ng.RSDs of precision,stability and reproducibility tests were all lower than 1.0％;the recoveries ranged 99.43％-100.14％ (RSD=0.25％,n=9).CONCLUSIONS:The optimized method is simple,accurate,sensitive and reproducible,which can be used for the determination of optical isomers in raltitrexed raw material.