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International Journal for Research Trends and Innovation
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ISSN Approved Journal No: 2456-3315 | Impact factor: 8.14 | ESTD Year: 2016
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Impact Factor : 8.14
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| Paper Title: | Bioanalytical method development and validation of LC-ESI-MS/MS for estimation of Regorafenib monohydrate in K3EDTA human plasma. |
| Authors Name: | Patel Krupa Jagdeeshbhai , Dr. Tulsidas Misra , Mr. Gajendra Solanki , Ms. Rajvi Mahida |
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| Author Reg. ID: |
IJRTI_189685
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| Published Paper Id: | IJRTI2404135 |
| Published In: | Volume 9 Issue 4, April-2024 |
| DOI: | |
| Abstract: | The objective is to develop and validate a bioanalytical method of LC-ESI-MS/MS for estimation Regorafenib monohydrate in K3EDTA human plasma. To quantify regorafenib monohydrate in human plasma, a simple, rapid, and sensitive isocratic reverse-phase liquid chromatography - tandem mass spectrometric method was developed. It was equipped with a Turbo Ion Spray (TIS) source and operated in the Multiple Reaction Monitoring (MRM) and Positive Ion modes. Analyte and ISTD were extracted from human plasma using the Liquid Liquid Extraction (LLE) method. Mobile Phase Composition was 2mM ammonium formate in water: Acetonitrile (30:70% v/v) for separation using ACE C18 column (100mm × 4.6mm, 5µm). With a total run time of 4.5 minutes, the drug and ISTD were retained at 2.4 minutes. Following optimization, the bioanalytical method was validated according to USDA and EMA bioanalysis guidelines. Liquid Liquid Extraction (LLE) was used to prepare the sample, and it produced clean extracts with recovery of 71.40% for ISTD and 76.64% for drug, respectively. Over the dynamic range of 10 - 25000 ng/ml, the LC-MS/MS method's analyte response was linear, with a regression coefficient r2 in the range of 0.9992-0.9994. At the Lower Limit of Quantification (LLOQ), the Accuracy was within the accepted range of ±20%, and at all other concentrations in the linear range, it was within ±15%. Thus, a simple, precise and sensitive isocratic reverse-phase liquid chromatographic tandem mass spectrometric method was developed to quantify Regorafenib Monohydrate in KEDTA human plasma. This method can be effectively used for BA/BE, toxicokinetic, and pharmacokinetic studies in human subjects. |
| Keywords: | LC-ESI-MS/MS, Regorafenib, Bioanalytical Method Development, Validation. |
| Cite Article: | "Bioanalytical method development and validation of LC-ESI-MS/MS for estimation of Regorafenib monohydrate in K3EDTA human plasma.", International Journal of Science & Engineering Development Research (www.ijrti.org), ISSN:2455-2631, Vol.9, Issue 4, page no.995 - 1003, April-2024, Available :http://www.ijrti.org/papers/IJRTI2404135.pdf |
| Downloads: | 000205196 |
| ISSN: |
2456-3315 | IMPACT FACTOR: 8.14 Calculated By Google Scholar| ESTD YEAR: 2016 An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 8.14 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator |
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Published Paper ID: IJRTI2404135
Registration ID:189685
Published In: Volume 9 Issue 4, April-2024
DOI (Digital Object Identifier):
Page No: 995 - 1003 Country: vapi,valsad, Gujrat, India Research Area: Pharmacy Publisher : IJ Publication Published Paper URL : https://www.ijrti.org/viewpaperforall?paper=IJRTI2404135 Published Paper PDF: https://www.ijrti.org/papers/IJRTI2404135 |
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ISSN: 2456-3315
Impact Factor: 8.14 and ISSN APPROVED,
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