摘要
建立了艾塞那肽含量的UPLC测定方法。采用AcquityUPLCBEHC18柱（1．7μm，2．1mm×50mm），检测波长为214nm，梯度洗脱，流动相A：0．1mol／L的四乙基高氯酸铵溶液；流动相B：100％乙腈溶液；流速为O．2mL/min，进样量为1．4μL，柱温为50℃。结果表明，艾塞那肽质量浓度在0．04～0.4mg／mL内与峰面积呈良好的线性关系，平均回收率为100．1％；稳定性实验表明，室温下艾塞那肽溶液8h内能稳定存在。艾塞那肽质量分数平均在98％以上，满足纯度要求。该检测方法能够快速简便地测定艾塞那肽质量分数，且成本较低，精度较高，适用于艾塞那肽的质量控制。
A UPLC method is established for the determination of exenatide. The experiment is performed with an Acquity BEH C18 （ 1.7 μm, 2. 1 × 50 mm） column and the mobile phase consisting of aeetonitrile and 0. 1% tetraethylammonium perchlorate with gradient elution. The flow rate of 0. 2 mL/min and the injection volume of 1.4 μL as well as the column temperature of 40℃ are employed. The result shows that the calibration curve for exenatide is linear within the range of 0.0g -0.4 mg/mL. The average recovery is 100. 1%. Stability tests show that the exenatide is stable within 8 hours at room temperature. The average determination of exenatide is above 98%. The method is proved to be rapid and accurate and can be used for the quality control of exenatide.
出处
《现代化工》
CAS
CSCD
北大核心
2015年第7期164-166,168,共4页
Modern Chemical Industry
