HPLC快速测定印度仿制新型冠状病毒治疗药物中5种抗病毒成分

黄艳婷; 庄玥; 邱蕴绮

doi:10.13748/j.cnki.issn1007-7693.20231337

HPLC快速测定印度仿制新型冠状病毒治疗药物中5种抗病毒成分

Rapid Determination of 5 Antiviral Compounds in Indian Generic for Anti-COVID-19 by HPLC

摘要

摘要:
目的建立HPLC同时快速测定印度仿制新型冠状病毒治疗药物中5种抗病毒成分(莫诺拉韦、奥司他韦、达卡他韦、奈玛特韦、利托那韦)。
方法样品经甲醇超声提取，用Agilent Poroshell 120 EC-C₁₈色谱柱(50 mm×4.6 mm，2.7 μm)分离，以甲酸水溶液pH(3.0±0.1)-乙腈为流动相进行梯度洗脱，流速1.5 mL·min⁻¹，柱温35 ℃，进样量10 μL，二极管阵列检测器检测，检测波长为210 nm，外标法定量。
结果 5种抗病毒成分在一定质量浓度范围内线性良好，相关系数均≥0.9997。5种成分的检出限为24~25 μg·g⁻¹，定量限为80~84 μg·g⁻¹。5种成分在3个加标水平的平均回收率为96.6%~104.3%，RSD为0.9%~1.9%。
结论该方法快速、准确，适用于印度仿制新型冠状病毒治疗药物中5种抗病毒成分的快速筛查，具有广阔的应用前景。

Abstract:
OBJECTIVE To develop an HPLC method for rapid determination of 5 antiviral compounds(molnupiravir, oseltamivir, daclatasvir, nirmatrelvir, and ritonavir) in Indian generic for anti-COVID-19.
METHODS The samples were ultrasonically extracted with methanol, and separated on an Agilent Poroshell 120 EC-C₁₈ column(50 mm×4.6 mm, 2.7 μm) at 35 ℃ by gradient elution with formic acid aqueous solutionpH(3.0±0.1)-acetonitrile as mobile phase at a flow rate of 1.5 mL·min⁻¹ , the injection volume was 10 μL. The detection wavelength for diode array detector was set at 210 nm. Quantification analysis was performed by the external method.
RESULTS The calibration curves for the 5 compounds showed good linearity in a certain range of mass concentration with their correlation coefficients ≥ 0.999 7. The limits of detection and limits of quantitation for 5 compounds were 24−25 μg·g⁻¹ and 80−84 μg·g⁻¹. The average recoveries of 5 compounds at three spiked levels(low, middle and high) ranged from 96.6%−104.3%, with RSD of 0.9%−1.9%.
CONCLUSION The method is rapid and accurate, and can be used for the rapid screening of 5 antiviral components in Indian generic for anti-COVID-19, indicating its extensive application prospect.

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