| SEC-HPLC法测定重组人生长激素注射液中苯酚含量 |
| |
| 引用本文： | 陆春燕,;李增礼,;王荣海,;宋礼华.SEC-HPLC法测定重组人生长激素注射液中苯酚含量[J].生物学杂志,2014(3):88-90. |
| |
| 作者姓名： | 陆春燕 ;李增礼 ;王荣海 ;宋礼华 |
| |
| 作者单位： | [1]安徽安科生物工程(集团)股份有限公司,合肥230088; [2]安徽省生物研究所,合肥230088 |
| |
| 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。
|
| 关 键 词： | 色谱法 高压液相 苯酚 重组人生长激素 |
Determination of Phenol concent in recombinant human growth hormone injection by SEC-HPLC |
| |
| Institution: | LU Chun-yan,LI Zeng-li,WANG Rong-hai,SONG Li-hua(1. Anhui Anke Bioteehnology(group) CO. ,LTD, Hefei 230088; 2. Anhui Institute of Biology, Hefei 230088, China) |
| |
| Abstract: | 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. |
| |
| Keywords: | chromatography high pressure liquid phenol recombinant human growth hormone |
| 本文献已被 维普 等数据库收录！ |
|
