Establishment of a Rapid and Highly Sensitive Reverse-phase High-performance Liquid Chromatography Based Analytical Assay Method for Duvelisib

Abstract:

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.

Key words: Duvelisib, HPLC, Analytical assay method, Development, Validation.