Work

Development of a chromatographic method for the analysis of risdiplam in serum extracts

Year: 2026

Type: article

Abstract: BACKGROUND: Risdiplam has been used to treat spinal muscular atrophy for 3 years. There are limited number of papers devoted to its analytics. Until now, risdiplam and its metabolites have only been analyzed using a C18 column, while the sample preparation method involved protein precipitation. RESEARCH DESIGN AND METHODS: Risdiplam was analyzed using reversed-phase UHPLC. The experiment was designed to compare the retention of risdiplam on five columns using various mobile phases. The protein precipitation was used as the sample preparation method. RESULTS: Risdiplam shows greater retention on phenyl columns, where π-π interactions take part in retention. The increase of mobile phase pH caused increased risdiplam retention, while salt concentration had no significant effect. An octadecyl column with pentafluorophenyl groups was selected with a mobile phase containing 10 mM ammonium formate (pH 4) and acetonitrile. The method was characterized by good linearity, repeatability, and short analysis time. It was applied to risdiplam analysis in serum samples after protein precipitation with different solvents. Finally, proteins were effectively precipitated using 10% TFA solution, providing 90% recovery. CONCLUSIONS: The developed procedure of extraction and determination of risdiplam is simple, fast and reliable. It may find application for routine monitoring of risdiplam or for quality control.

Source: Bioanalysis

DOI: 10.1080/17576180.2026.2624594

Authors: Natalia Balińska, Anna Lemska, Maria Mazurkiewicz-Bełdzińska, Sylwia Studzińska

Institutions: Nicolaus Copernicus University, Gdańsk Medical University

Language: English

Topic: Analytical Methods in Pharmaceuticals

Subfield: Analytical Chemistry

Field: Chemistry

Domain: Physical Sciences

SDG: Good health and well-being

Open Access status: green

Funder: Narodowym Centrum Nauki