Ultra‐high‐performance liquid chromatography method development for the quantification of Molnupiravir and its process‐related impurities using Box‐Behnken experimental design

IF 1.3 Q4 CHEMISTRY, ANALYTICAL SEPARATION SCIENCE PLUS Pub Date : 2024-02-01 DOI:10.1002/sscp.202300213
Mohana Vamsi Nuli, Darna Bhikshapathi, Anil Kumar Garige, Vijitha Chandupatla, Surya Lakshmi Sunkara, P. Grover
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Abstract

Molnupiravir, a promising antiviral agent, has gained significant attention for its potential in treating viral infections, particularly in the context of the coronavirus disease 2019 pandemic. This study aimed to develop and validate an ultra‐high‐performance liquid chromatography (UHPLC) method for the quantification of Molnupiravir and its associated impurities (Imp‐I, Imp‐II, Imp‐III, and Imp‐IV). The method involved a systematic investigation of critical method parameters and their optimization using Quality by Design principles. The percentage of organic modifiers, column temperature, and flow rate were systematically optimized using the Box‐Behnken design. The developed method was assessed for specificity, system suitability, accuracy, precision, linearity, and detection limits. The results demonstrate strong specificity, with the analysis remaining accurate even in the presence of impurities. The developed method exhibits excellent precision, with repeatability and intermediate precision showing relative standard deviation values ranging from 0.78% to 1.14% for impurities and 0.82% to 1.91% for Molnupiravir. Furthermore, the method displays exceptional linearity, covering a wide range of concentrations. The linear regression analysis yields high coefficients of determination (r2, 9993–0.9997), confirming the linearity. The developed UHPLC method is well‐suited for the accurate and reliable analysis of Molnupiravir and its impurities, making it a valuable tool for quality control and pharmaceutical research applications.
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利用方框-贝肯实验设计开发用于定量检测莫能吡韦及其工艺相关杂质的超高效液相色谱法
莫能吡韦是一种前景广阔的抗病毒药物,因其在治疗病毒感染方面的潜力而备受关注,尤其是在2019年冠状病毒疾病大流行的背景下。本研究旨在开发和验证一种超高效液相色谱(UHPLC)方法,用于定量检测莫能吡韦及其相关杂质(Imp-I、Imp-II、Imp-III 和 Imp-IV)。该方法采用质量源于设计原则,对关键方法参数进行了系统研究和优化。采用 Box-Behnken 设计对有机改性剂的比例、色谱柱温度和流速进行了系统优化。对所开发的方法进行了特异性、系统适用性、准确度、精密度、线性度和检测限的评估。结果表明,该方法具有很强的特异性,即使在存在杂质的情况下也能保持分析的准确性。所开发的方法具有极佳的精密度,重复性和中间精密度显示杂质的相对标准偏差值在 0.78% 至 1.14% 之间,莫能吡韦的相对标准偏差值在 0.82% 至 1.91% 之间。此外,该方法还显示出卓越的线性度,可覆盖广泛的浓度范围。线性回归分析得出了较高的测定系数(r2,9993-0.9997),证实了该方法的线性关系。所开发的超高效液相色谱法非常适合于准确可靠地分析莫能吡韦及其杂质,是质量控制和药物研究应用的重要工具。
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来源期刊
SEPARATION SCIENCE PLUS
SEPARATION SCIENCE PLUS CHEMISTRY, ANALYTICAL-
CiteScore
1.90
自引率
9.10%
发文量
111
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