Establishment of a rapid and highly sensitive reverse-phase high-performance liquid chromatography based analytical assay method for duvelisib
By: Sonawane, Dipali
.
Contributor(s): Sahu, Amit Kumar.
Publisher: Karnataka Association of Pharmaceutical Teachers of India (APTI) 2022Edition: Vol.56(1), Jan-Mar.Description: 287-295p.Subject(s): PHARMACEUTICSOnline resources: Click here
In:
Indian journal of pharmaceutical education and researchSummary: Background: Duvelisib is an antineoplastic agent that received global approval from the
United States Food and Drug Administration in 2018. An extensive literature search
revealed that analytical method for the quantification of duvelisib at nanogram level is not
available till date. A highly sensitive analytical method is necessary to analyze diversified
samples containing trace levels of the analyte such as dissolution samples of sustained
release formulation, cross-contamination study samples etc. Materials and Methods:
Primary aim of this research was to develop a high throughput, accurate, reproducible,
and highly sensitive high performance liquid chromatography method for quantification
of duvelisib and validate according to the International Council for Harmonisation of
Technical Requirements for Pharmaceuticals for Human Use and Association of Official
Analytical Collaboration guidelines. Results: A linear relationship was confirmed over
70 to 5000 ng/mL concentrations with a limit of detection value of 20 ng/mL. The
intra and inter-day precision were found to be 0.97 to 1.87% and 1.25 to 1.99%,
respectively. Conclusion: This is the first time to report a quantitative assay method
for duvelisib, which can quantify the analyte even at the nanogram level. This method
will be suitable for sample analysis of quality control, stability, cross-contamination,
dissolution study of sustained-release formulation and effluent analysis of duvelisib in
pharmaceutical industries and research laboratories.
| Item type | Current location | Call number | Status | Date due | Barcode | Item holds |
|---|---|---|---|---|---|---|
Articles Abstract Database
|
School of Pharmacy Archieval Section | Not for loan | 2022-1728 |
Background: Duvelisib is an antineoplastic agent that received global approval from the
United States Food and Drug Administration in 2018. An extensive literature search
revealed that analytical method for the quantification of duvelisib at nanogram level is not
available till date. A highly sensitive analytical method is necessary to analyze diversified
samples containing trace levels of the analyte such as dissolution samples of sustained
release formulation, cross-contamination study samples etc. Materials and Methods:
Primary aim of this research was to develop a high throughput, accurate, reproducible,
and highly sensitive high performance liquid chromatography method for quantification
of duvelisib and validate according to the International Council for Harmonisation of
Technical Requirements for Pharmaceuticals for Human Use and Association of Official
Analytical Collaboration guidelines. Results: A linear relationship was confirmed over
70 to 5000 ng/mL concentrations with a limit of detection value of 20 ng/mL. The
intra and inter-day precision were found to be 0.97 to 1.87% and 1.25 to 1.99%,
respectively. Conclusion: This is the first time to report a quantitative assay method
for duvelisib, which can quantify the analyte even at the nanogram level. This method
will be suitable for sample analysis of quality control, stability, cross-contamination,
dissolution study of sustained-release formulation and effluent analysis of duvelisib in
pharmaceutical industries and research laboratories.
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