摘要:
目的 建立高效液相色谱法测定人凝血因子Ⅷ制品中甘氨酸含量的方法。 方法 采用Shim-pack CLC-ODS色谱柱,以丙氨酸为内标,2、4-二硝基氟苯(DNFB)为柱前衍生剂,50%乙腈溶液-0.05 mol/L醋酸钠缓冲液(35:65)为流动相,检测波长为360 nm。 结果 甘氨酸在0.006~0.030 mg/ml浓度范围内线性关系良好(r=0.999 3),平均回收率为101.4%,RSD为0.14%(n=9)。 结论 该方法简单灵敏,结果准确可靠,可用于人凝血因子Ⅷ制品中甘氨酸含量的测定。
Abstract:
Objective To establish the method for determination content of glycine in the pharmaceutical of human coagulation 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-dinitrofluorobenzene 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 pharmaceutical of human coagulation factor Ⅷ.
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