摘要
建立RP-HPLC测定精蛋白胰岛素注射液中硫酸鱼精蛋白含量的方法。采用G18色谱柱（250mm×4．6mm，5μn），流动相A为0．1mol／L磷酸二氢钠溶液（用磷酸调至pHl．8），流动相B为乙腈-0．1mol／L磷酸二氢钠溶液（用磷酸调至pHl．8）（35：65），采用梯度洗脱，柱温为55℃，总流速为1．0ml／mim检测波长214nm，进样量为100μl。结果：硫酸鱼精蛋白在0．101～1．013mg／ml呈线性关系，回归方程为A-4．534×10^5＋3.839×10^7C，r=0．9998；平均回收率为101．01％，RSD％为1．05（n=9）。此法快速、简便、准确，可测定各种胰岛素注射剂中硫酸鱼精蛋白的含量。
To establish a RP-HPLC method to determine protamine sulphate in insulin drug products for injection. C-18 column（250 mm×4.6 mm, 5 μm）, the mobile phase consisting of eluent A：0.1 mol/L sodium biphosphate （adjusted pH to 1.8 with phosphoric acid） and eluent B：acetonitrile-0. 1 mol/L sodium biphosphate （adjusted pH to 1.8 with phosphoric acid） （35 - 65） for gradient elution, column temperature of 55℃ and total flow rate 1.0 ml/min. The detection was done at wavelength 214 nm,with injection amount 100/11. The calibration curve was linear in the range of 0. 101-1. 013 mg/ml, and the regression equation was A = 4. 534 × 10^5＋3. 839 ×10^7C, r= 0.9998. The average recoveries were 101.01%,and the RSD% was 1.05 （n=9）. This method appeared to be rapid,simple and accurate. It can be used to determine protamine sulphate in insulin drug products for injection.
出处
《药物生物技术》
CAS
CSCD
2008年第3期212-215,共4页
Pharmaceutical Biotechnology
