UGC Approved Journal no 63975

ISSN: 2349-5162 | ESTD Year : 2014
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Volume 10 Issue 1
January-2023
eISSN: 2349-5162

UGC and ISSN approved 7.95 impact factor UGC Approved Journal no 63975

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Published Paper ID:
JETIR2301063


Registration ID:
506543

Page Number

a471-a506

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Title

Analytical Method Development and Validation for The Quantitative Estimation of Elexacaftor, Ivacaftor and Tezacaftor in Bulk and Tablet Formulation by RP – HPLC and Its Application in Dissolution Studies

Abstract

This study displayed method development and its validation by RP-HPLC in combined assessment process to assay ivacaftor (IVR), elexacaftor (EXR) & tezacaftor (TZR) contents in Trikafta pills using 150 mm C18 Inertsil column with 60:40 volume/volume proportionality, KH2PO4 (0.1M) & methanol blend mobile phase. IVR, EXR & TZR were spotted and accurately assessed at a wavenumber of 262 nm. The RT minutes are 2.055 min (TZR), 2.640 (IVR) & 3.272 min (EXR). With concentrations tend to range from 37.5 – 112.50μg/ml (IVR), 50-150μg/ml (EXR) and 25 – 75μg/ml (TZR), linear responses are received. LODs for IVR, EXR & TZR are 0.259μg/ml, 0.241μg/ml & 0.167μg/ml, respectively. LOQs for IVR, EXR & TZR are 0.863μg/ml, 0.804μg/ml & 0.556μg/ml, respectively. Precision for IVR, EXR & TZR are 0.278%RSD, 0.214%RSD & 0.625%RSD, respectively. Accuracy for IVR, EXR & TZR is 98.82%recovery, 99.29%recovery & 98.08%recovery. The RP-HPLC combined assessment process is also proficiently implemented for dissolution study of IVR, EXR, & TZR.

Key Words

RP-HPLC, Dissolution Study, Ivacaftor, Tezacaftor, Elexacaftor

Cite This Article

"Analytical Method Development and Validation for The Quantitative Estimation of Elexacaftor, Ivacaftor and Tezacaftor in Bulk and Tablet Formulation by RP – HPLC and Its Application in Dissolution Studies", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.10, Issue 1, page no.a471-a506, January-2023, Available :http://www.jetir.org/papers/JETIR2301063.pdf

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2349-5162 | Impact Factor 7.95 Calculate by Google Scholar

An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 7.95 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator

Cite This Article

"Analytical Method Development and Validation for The Quantitative Estimation of Elexacaftor, Ivacaftor and Tezacaftor in Bulk and Tablet Formulation by RP – HPLC and Its Application in Dissolution Studies", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.10, Issue 1, page no. ppa471-a506, January-2023, Available at : http://www.jetir.org/papers/JETIR2301063.pdf

Publication Details

Published Paper ID: JETIR2301063
Registration ID: 506543
Published In: Volume 10 | Issue 1 | Year January-2023
DOI (Digital Object Identifier):
Page No: a471-a506
Country: HYDERABAD, TELANGANA, India .
Area: Pharmacy
ISSN Number: 2349-5162
Publisher: IJ Publication


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