Determination of Residual Solvents in Decitabine for Injection by Capillary GC / 中国药房

ABSTRACT

OBJECTIVE:To establish a method for determining residual solvents in Decitabine for injection. METHODS:Cap-illary GC method was adopted,and the contents of residual solvents were calculated by internal standard method. The column was capillary column Agilent DB-624,flame ionization detector was used with the temperature of 280 ℃ by temperature programming, and the temperature of injector was 230 ℃,nitrogen was used as the carrier gas,flow rate was 1.5 ml/min and the split ratio was 501,direct injection was used,and the sample size was 1 μl. RESULTS:The linear range was 0.100 3-2.507 mg/ml for ethanol , 0.101 3-2.532 mg/ml for ether,0.102 2-2.556 mg/ml for isopropanol,0.008 3-0.207 8 mg/ml for acetonitrile,0.012 4-0.309 3 mg/ml for methylene chloride,0.014 8-0.369 4 mg/ml for tetrahydrofuran,0.078 1-1.953 mg/ml for cyclohexane,0.024 9-1.250 mg/ml for toluene and 0.017 6-0.440 9 mg/ml for N,N-dimethylformamide(r≥0.999 2);RSDs of precision and reproducibility tests were lower than 2%;recovery was 96.70%-101.60%(RSD was 0.59%-1.82%,n=9). CONCLUSIONS:The method is simple,accurate and reproducible and suitable for determining the residual solvents in Decitabine for injection.