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用于首次同时测定人血浆和剂型中作为二元混合物的莫努匹拉韦和厄他培南的HPLC/UV方法,作为COVID-19治疗方案。

HPLC/UV approach method for the first simultaneous estimation of molnupiravir and ertapenem as a binary mixture in human plasma and dosage form as a regimen for COVID-19 treatments.

作者信息

Afify Khaled K, Ali Ramadan, El-Dosoky Mohammad A, Nassar Mohamed Wafaa I

机构信息

Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Al-Azhar University, Assuit branch, 71524, Assuit, Egypt.

Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Tabuk, 71491, Tabuk, Saudi Arabia.

出版信息

BMC Chem. 2023 Sep 21;17(1):121. doi: 10.1186/s13065-023-01024-y.

Abstract

COVID-19 is a serious virus that can have a lot of effects, one of which is a secondary bacterial infection that can be more life-threatening and even lethal than the initial viral infection. Hence a fast and sensitive HPLC/UV method was developed and validated for the first estimation of a binary mixture of molnupiravir (MOL) and ertapenem (ERT) as a co-administrated medicine for the management of COVID-19 in pharmaceutical dosage forms, and human plasma samples. The drug combination was separated within 5 min via RP-ODS column using isocratic elution with a mobile phase of 0.05 M phosphate buffer (pH 3.5): acetonitrile with a 76: 24% ratio v/v. The presented method provided a linear response ranging from 0.03 to 17.0 and 0.05-20 µg mL with LOD values of 0.009 and 0.008 µg mL for MOL and ERT respectively. The good separation and high sensitivity of the HPLC method provide the determination of the cited drugs in human plasma without matrix interference with a percent of recovery ranging from 94.97 ± 2.05 to 98.44 ± 1.92. Based on the results, this method could be utilized to monitor cited drugs in quality control and therapeutic laboratories.

摘要

新型冠状病毒肺炎(COVID-19)是一种严重的病毒,可产生多种影响,其中之一是继发性细菌感染,这种感染可能比最初的病毒感染更具生命威胁性,甚至致命。因此,开发并验证了一种快速灵敏的高效液相色谱/紫外(HPLC/UV)方法,用于首次测定作为治疗COVID-19的联合用药的莫努匹拉韦(MOL)和厄他培南(ERT)在药物剂型和人血浆样品中的二元混合物。通过RP-ODS柱在5分钟内分离药物组合,采用等度洗脱,流动相为0.05M磷酸盐缓冲液(pH 3.5):乙腈,体积比为76:24%。该方法的线性响应范围为0.03至17.0以及0.05 - 20μg/mL,莫努匹拉韦和厄他培南的检测限分别为0.009和0.008μg/mL。HPLC方法良好的分离度和高灵敏度可在无基质干扰的情况下测定人血浆中的上述药物,回收率范围为94.97±2.05至98.44±1.92。基于这些结果,该方法可用于质量控制和治疗实验室监测上述药物。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d971/10515236/4ebf2ce453da/13065_2023_1024_Fig1_HTML.jpg

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