UPLC-PDA Approach for Simultaneous Quantification of Elvitegravir, Tenofovir, Emtricitabine and Cobicistat in Tablets: An MS-ESI Study for Degradation Products.

IF 1.5 4区化学 Q4 BIOCHEMICAL RESEARCH METHODS Journal of chromatographic science Pub Date : 2024-10-01 DOI:10.1093/chromsci/bmad067

Rajya Lakshmi Nimmagadda, Sowjanya Gummadi

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Abstract

A simultaneous ultra-performance liquid chromatography photodiode array detection method was developed and validated for Elvitegravir, Tenofovir and Emtricitabine and Cobicistat drugs in tablet dosage forms. Effective liquid chromatographic quantification was achieved using a Luna C18 (100 × 2.6 mm, 1.6 μ) column with an acetonitrile: 0.1% v/v trifluoro acetic acid (80:20% v/v) mobile phase and a photo diode array detector at 260 nm for a shorter run time of 3 min. The respective retention times for Elvitegravir, Tenofovir, Emtricitabine and Cobicistat were 0.311, 0.792, 1.379 and 2.045 min. The range of linearity was 37.50-225.00, 2.50-15.00, 50.00-300.00 and 37.50-225.00 μg/mL for Elvitegravir, Tenofovir, Emtricitabine and Cobicistat, respectively. A mass spectrometer was employed for quantitative analysis using electron spray ionization multiple reaction monitoring in positive mode. The developed method was validated for different parameters to meet the acceptance criteria as per ICH Q2 (R1) guidelines. Using UPLC-ESI-MS, 12 degradants were identified and their mechanisms were studied.

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采用 UPLC-PDA 方法同时定量片剂中的埃替拉韦、替诺福韦、恩曲他滨和考比司他：降解产物的 MS-ESI 研究。

建立并验证了片剂药物埃替拉韦、替诺福韦、恩曲他滨和考比司他的同步超高效液相色谱-光电二极管阵列检测方法。采用 Luna C18 (100 × 2.6 mm, 1.6 μ)色谱柱，以乙腈：0.1% v/v 三氟乙酸（80:20% v/v）为流动相，在 260 nm 波长下使用光电二极管阵列检测器进行检测，在 3 分钟的较短时间内实现了有效的液相色谱定量。Elvitegravir、Tenofovir、Emtricitabine 和 Cobicistat 的保留时间分别为 0.311、0.792、1.379 和 2.045 分钟。Elvitegravir、Tenofovir、Emtricitabine 和 Cobicistat 的线性范围分别为 37.50-225.00、2.50-15.00、50.00-300.00 和 37.50-225.00 μg/mL。质谱仪采用电子喷雾电离多反应监测正离子模式进行定量分析。根据 ICH Q2 (R1) 指南，对所开发的方法进行了不同参数的验证，以满足验收标准。利用 UPLC-ESI-MS 鉴定了 12 种降解剂，并研究了它们的作用机制。

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来源期刊

Journal of chromatographic science 化学-分析化学

CiteScore

2.90

自引率

7.70%

发文量

审稿时长

5.6 months

期刊介绍： The Journal of Chromatographic Science is devoted to the dissemination of information concerning all methods of chromatographic analysis. The standard manuscript is a description of recent original research that covers any or all phases of a specific separation problem, principle, or method. Manuscripts which have a high degree of novelty and fundamental significance to the field of separation science are particularly encouraged. It is expected the authors will clearly state in the Introduction how their method compares in some markedly new and improved way to previous published related methods. Analytical performance characteristics of new methods including sensitivity, tested limits of detection or quantification, accuracy, precision, and specificity should be provided. Manuscripts which describe a straightforward extension of a known analytical method or an application to a previously analyzed and/or uncomplicated sample matrix will not normally be reviewed favorably. Manuscripts in which mass spectrometry is the dominant analytical method and chromatography is of marked secondary importance may be declined.