摘要
采用SEC-HPLC法测定重组人生长激素注射液中苯酚的含量。色谱柱为TSK G2000SWxL（7.8×300mm,5μ）,流动相为PB（pH值7.0）-异丙醇（97∶3）,流速0.6 mL/min,检测波长214nm,柱温25℃。苯酚在0.10～1.00 mg/mL浓度范围内线性关系良好,r=0.99915;最低检测限为0.5 ng/mL;平均回收率101.48%,RSD=0.58%（n=9）;3批重组人生长激素注射液中苯酚的含量分别为2.98、3.02和2.96 mg/mL,分别为标示量的99.33%、100.67%和98.67%。SEC-HPLC法环保、准确、快速、可靠,可用于重组人生长激素注射液中苯酚含量的测定。
To established an HPLC method for the determination of phenol content in recombinant human growth hormone injection,TSK G2000SWxLcolumn（ 7. 8 × 300 mm,5μ） was used with the mobile phase 0. 063 M PB（ pH7. 0）- isopropyl alcohol（ 97： 3） at flow rate of 0. 6 mL /min. The UV detection wavelength was 214 nm,and the column temperature was 25℃. The calibration curve of phenol showed good linearity in the range of 0. 10- 1. 00 mg /mL,r = 0. 99915. The minimum limit of detection was 0. 5 ng /mL,and the mean recovery（ n = 9） was 101. 48% with a RSD of 0. 58%. The phenol contents in three batches of recombinant human growth hormone injection were 2. 98,3. 02 and 2. 96 mg /mL,which were 99. 33%,100. 67% and 98. 67% of stated amounts,respectively. Result showed SEC-HPLC method was environment-friendly,accurate,rapid and reliable,which might be used for determination of phenol content in recombinant human growth hormone injection.
出处
《生物学杂志》
CAS
CSCD
2014年第3期88-90,共3页
Journal of Biology
关键词
色谱法
高压液相
苯酚
重组人生长激素
chromatography
high pressure liquid
phenol
recombinant human growth hormone
