首页|HPLC法测定注射用特利加压素中有关物质

HPLC法测定注射用特利加压素中有关物质

Determination of related substances in Terlipressin for injection by HPLC

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目的 建立 HPLC 法测定注射用特利加压素中有关物质.方法 采用 Agilent Poroshell 120EC-C18 色谱柱(150 mm×4.6 mm,2.7 μm);磷酸二氢钾缓冲液-乙腈(90∶10)为流动相A,磷酸二氢钾缓冲液-乙腈(60∶40)为流动相B,梯度洗脱;检测波长为 210 nm;体积流量为 0.7 mL/min;进样量为 20 μL;柱温为 35℃.按照主成分对照品外标法计算.结果 杂质 L、K、G、I、D、H、E、F、Y、P、M、B、T、J、N 在 0.04～40.8 μg/mL 线性关系良好;平均回收率分别为99.46%、98.35%、98.24%、99.15%、100.01%、99.34%、99.56%、99.42%、98.79%、98.64%、99.16%、98.22%、99.31%、98.11%、99.38%,RSD值分别为 0.98%、1.23%、1.45%、0.85%、1.21%、1.09%、1.16%、0.94%、1.25%、0.79%、1.42%、0.92%、0.88%、1.72%、1.26%.结论 建立的方法准确、专属性强,可用于注射用特利加压素中有关物质的质量控制.
Objective To establish an HPLC method for determination of substances in Terlipressin for injection.Methods Agilent Poroshell 120EC-C18 column(150 mm×4.6 mm,2.7 μm)was used.Mobile phase A was potassium dihydrogen phosphate buffer-acetonitrile(90:10),mobile phase B was potassium dihydrogen phosphate buffer-acetonitrile(60:40),and gradient elution was carried on.Detection wavelength was set at 210 nm,volume flow rate was 0.7 mL/min,and injection volume was 20 μL.Column temperature was 35℃.The related substances were calculated using the principal component reference standard external standard method.Results The linear range of impurities L,K,G,I,D,H,E,F,Y,P,M,B,T,J,and N was 0.04-40.80 μg/mL.The average recovery was 99.46%,98.35%,98.24%,99.15%,100.01%,99.34%,99.56%,99.42%,98.79%,98.64%,99.16%,98.22%,99.31%,98.11%,and 99.38%,respectively,and the RSD value was 0.98%,1.23%,1.45%,0.85%,1.21%,1.09%,1.16%,0.94%,1.25%,0.79%,1.42%,0.92%,0.88%,1.72%,and 1.26%.Conclusion The established method is accurate and highly specific,and can be used for quality control of related substances in Terlipressin for injection.

Terlipressin for injectionrelated substanceimpurity Limpurity KHPLC

王培、段玺玉、鲁鑫、马冰、覃婷婷、白海娇、韩晓捷

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天津市药品检验研究院,天津 300070

注射用特利加压素 有关物质 杂质L 杂质K 高效液相色谱

2023年国家药品抽检项目

国药监药管[2023]2号

2024

10.7501/j.issn.1674-5515.2024.10.011

现代药物与临床
天津药物研究院,中国药学会

现代药物与临床

CSTPCD
影响因子：1.179
ISSN：1674-5515
年,卷(期)：2024.39(10)
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