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
{"title":"LC-MS/MS Method Development and Validation for Determination of Favipiravir Pure and Tablet Dosage Forms.","authors":"Nandeesha Itigimath,&nbsp;Hadagali Ashoka,&nbsp;Basappa C Yallur,&nbsp;Manjunatha Devagondanahalli Hadagali","doi":"10.4274/tjps.galenos.2022.75470","DOIUrl":null,"url":null,"abstract":"<p><strong>Objectives: </strong>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.</p><p><strong>Materials and methods: </strong>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, C<sub>18</sub> (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<sup>-1</sup>. 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.</p><p><strong>Results: </strong>The linearity graph was found in the range of 50-200 μg/mL and the correlation coefficient value (R<sup>2</sup>) 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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":23378,"journal":{"name":"Turkish Journal of Pharmaceutical Sciences","volume":"20 4","pages":"226-233"},"PeriodicalIF":1.8000,"publicationDate":"2023-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10445228/pdf/TJPS-20-226.pdf","citationCount":"1","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Turkish Journal of Pharmaceutical Sciences","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.4274/tjps.galenos.2022.75470","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
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.

查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
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。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 去求助
来源期刊
CiteScore
3.60
自引率
5.90%
发文量
79
期刊最新文献
A Novel Controlled Release Implant of Insulin Based on Poly(3-hydroxybutyrate-co-3-hydroxyvalerate) Polymer Prepared by Extrusion. Optimization of Enterocin Production from Probiotic Enterococcus faecium Using Taguchi Experimental Design. Evaluation of a Synthetic PEI-based Polymeric Vector for ING4 Gene Delivery to MCF-7 Breast Cancer Cells Evaluation of Anticancer and Antioxidant Activities of Coffee Stem Parasite Extract (Scurrula Ferruginea (Roxb. Ex Jack) Danser) and in Silico Studies of its Isolate Development of Cyclosporine A Nanosuspension using Experimental Design by Response Surface Methodology: In Vitro Evaluations
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1