RP-HPLC法测定重组人生长激素注射液中间甲酚含量

RP-HPLC determination of metacresol in Human growth hormone recombination injection

目的:建立测定重组人生长激素注射液中间甲酚含量的方法。方法:采用RP-HPLC法,色谱柱为ShiseidoC4(250mmx4.6mm,5um),流动相为0.05MTris-HCL(pH7.5)-正丙醇(71:29),流速0.5ml/min,检测波长为317nm,柱温为40℃。结果:间甲酚在0.2mg-0.8mg/ml(r=0.9996,n=5)浓度范围内与峰面积呈良好线性关系,最低检出线为0.1ng,平均回收率为100.5%(n=9)。结论:本方法准确,重现性好,可为重组人生长激素注射液质量评价提供较为可靠的分析方法。

Objective： To establish an HPLC method for the determination of metacresol in Human growth hormone recombination injection. Methods： ShiseidoC4 column （250 mm×4.6 mm, 5 um）was used and the mobile phase was 0.05 M Tris-HCL （pH 7.5 ）-n-propyl alcoho （71：29 ）at flow rate of 0.5 ml/min. The UV detection wavelength was 270 nm ,and the column temperature was 40~C. Result： the calibration curve of metacresol was linear in the range of 0.2 mgl-0.8 mg/ml （r=0.9996,n=5） with the minimum limit of detection was 1.0ng. The mean recovery （n=9）was 100.5 %. Conclusion： This is an accurate an credible quality control method for Human growth hormone recombination injection.