Establishment of a rapid and highly sensitive reverse-phase high-performance liquid chromatography based analytical assay method for duvelisib (Record no. 17643)

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003 - CONTROL NUMBER IDENTIFIER
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005 - DATE AND TIME OF LATEST TRANSACTION
control field 20220923155207.0
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fixed length control field 220923b xxu||||| |||| 00| 0 eng d
040 ## - CATALOGING SOURCE
Original cataloging agency AIKTC-KRRC
Transcribing agency AIKTC-KRRC
100 ## - MAIN ENTRY--PERSONAL NAME
9 (RLIN) 18093
Author Sonawane, Dipali
245 ## - TITLE STATEMENT
Title Establishment of a rapid and highly sensitive reverse-phase high-performance liquid chromatography based analytical assay method for duvelisib
250 ## - EDITION STATEMENT
Volume, Issue number Vol.56(1), Jan-Mar
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Place of publication, distribution, etc. Karnataka
Name of publisher, distributor, etc. Association of Pharmaceutical Teachers of India (APTI)
Year 2022
300 ## - PHYSICAL DESCRIPTION
Pagination 287-295p.
520 ## - SUMMARY, ETC.
Summary, etc. Background: Duvelisib is an antineoplastic agent that received global approval from the<br/>United States Food and Drug Administration in 2018. An extensive literature search<br/>revealed that analytical method for the quantification of duvelisib at nanogram level is not<br/>available till date. A highly sensitive analytical method is necessary to analyze diversified<br/>samples containing trace levels of the analyte such as dissolution samples of sustained<br/>release formulation, cross-contamination study samples etc. Materials and Methods:<br/>Primary aim of this research was to develop a high throughput, accurate, reproducible,<br/>and highly sensitive high performance liquid chromatography method for quantification<br/>of duvelisib and validate according to the International Council for Harmonisation of<br/>Technical Requirements for Pharmaceuticals for Human Use and Association of Official<br/>Analytical Collaboration guidelines. Results: A linear relationship was confirmed over<br/>70 to 5000 ng/mL concentrations with a limit of detection value of 20 ng/mL. The<br/>intra and inter-day precision were found to be 0.97 to 1.87% and 1.25 to 1.99%,<br/>respectively. Conclusion: This is the first time to report a quantitative assay method<br/>for duvelisib, which can quantify the analyte even at the nanogram level. This method<br/>will be suitable for sample analysis of quality control, stability, cross-contamination,<br/>dissolution study of sustained-release formulation and effluent analysis of duvelisib in<br/>pharmaceutical industries and research laboratories.
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
9 (RLIN) 4639
Topical term or geographic name entry element PHARMACEUTICS
700 ## - ADDED ENTRY--PERSONAL NAME
9 (RLIN) 18094
Co-Author Sahu, Amit Kumar
773 0# - HOST ITEM ENTRY
Title Indian journal of pharmaceutical education and research
Place, publisher, and date of publication Bengluru Association of Pharmaceutical Teachers of India (APTI)
International Standard Serial Number 0019-5464
856 ## - ELECTRONIC LOCATION AND ACCESS
URL https://www.ijper.org/sites/default/files/IndJPhaEdRes-56-1-287.pdf
Link text Click here
942 ## - ADDED ENTRY ELEMENTS (KOHA)
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Koha item type Articles Abstract Database
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    Dewey Decimal Classification     School of Pharmacy School of Pharmacy Archieval Section 23/09/2022   2022-1728 23/09/2022 23/09/2022 Articles Abstract Database
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