Determination of glycine in the pharmaceutical of human coagulation factor Ⅷ by HPLC / 药学实践杂志

ABSTRACT

Objective To establish the method for determination content of glycine in the pharmaceutical of human coag‐ulation factor Ⅷ by HPLC .Methods The analysis was carried on a Shim‐Pack CLC‐ODS column with a mobile phase of 50%acetonitrile‐0 .05 mol/L sodium acetate buffer (35∶65) at the detection wavelength of 360 nm ,using alanine and 2 ,4‐dini‐trofluorobenzene as the internal standard and derivation agent ,respectively .Results The method showed a good linearity in the range of 0 .006‐0 .030 mg/ml (r=0 .999 3) for glycine .The average recovery was 101 .4% ,and the RSD was 0 .14% (n=9) .Conclusion This method was simple ,sensitive ,accurate ,reliable ,and suitable for determination of glycine in the pharma‐ceutical of human coagulation factor Ⅷ .