LC-MS/MS Method Development and Validation for Determination of Favipiravir Pure and Tablet Dosage Forms.

IF 1.8 Q3 PHARMACOLOGY & PHARMACY Turkish Journal of Pharmaceutical Sciences Pub Date : 2023-08-22 DOI:10.4274/tjps.galenos.2022.75470
Nandeesha Itigimath, Hadagali Ashoka, Basappa C Yallur, Manjunatha Devagondanahalli Hadagali
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引用次数: 1

Abstract

Objectives: Analytical method development and validation for determination of favipiravir (FVPR) in pure and tablet dosage forms by liquid chromatography with tandem mass spectrometry/mass spectrometry (LC-MS/MS) technique.

Materials and methods: A simple LC-MS/MS method was developed for determination of a new antiviral drug, FVPR in pharmaceutical formulations. The stationary phase employed was a Shim pack GISS, C18 (100 mm × 2.1 mm, 1.9 μm) column and mobile phase used in pump A was 10.0 mM ammonium acetate and in pump B methanol was used. The gradient program was used with fixed mobile phase flow rate at 0.4 mL min-1. Total run time was 5.0 min. The proposed method was validated according to International Conference on Harmonization (ICH) guidelines. The established method found better outcomes.

Results: The linearity graph was found in the range of 50-200 μg/mL and the correlation coefficient value (R2) obtained was found to be 1.0. The limit of detection (LOD) and limit of quantification (LOQ) were 4.044 μg/mL and 12.253 μg/mL, respectively. Tremendous recovery outcomes were observed and found to be 101%, 99.0%, and 99.5% for FVPR at 150% upper, 100% middle, and 50% lower concentrations, respectively.

Conclusion: All outcomes obtained comply with ICH guidelines. The developed method was simple, unique, accurate, robust, precise, and reproducible for determination of FVPR in tablet formulation. The method is novel and could be adopted in formulation industry.

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法匹拉韦纯剂型和片剂的LC-MS/MS方法建立与验证。
目的:建立液相色谱-串联质谱/质谱(LC-MS/MS)技术测定法匹拉韦(FVPR)纯剂型和片剂剂型的分析方法并进行验证。材料与方法:建立了一种新型抗病毒药物制剂中FVPR含量测定的LC-MS/MS方法。固定相为Shim pack GISS, C18 (100 mm × 2.1 mm, 1.9 μm)色谱柱,流动相为10.0 mm乙酸铵,B泵为甲醇。采用梯度程序,固定流动相流速为0.4 mL min-1。总运行时间为5.0 min。根据国际协调会议(ICH)指南验证了所提出的方法。既定方法的效果更好。结果:在50 ~ 200 μg/mL范围内线性关系良好,相关系数(R2)为1.0。检测限和定量限分别为4.044 μg/mL和12.253 μg/mL。在150%高浓度、100%中浓度和50%低浓度条件下,FVPR的回收率分别为101%、99.0%和99.5%。结论:所有结果均符合ICH指南。该方法简便、准确、可靠、精密度高、重复性好,可用于片剂中FVPR的测定。该方法新颖,可应用于制剂行业。
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CiteScore
3.60
自引率
5.90%
发文量
79
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