Quality by design‐assisted development of a capillary electrophoresis method for the enantiomeric purity determination of tenofovir. Issue 9 (23rd January 2022)

• Record Type: Journal Article
• Authors: Krait, Sulaiman; Schneidmadel, Felix R.; Scriba, Gerhard K. E.
• Editors: Griend, Cari Sänger – van de; Scriba, Gerhard; Wätzig, Hermann
• Is Part Of: Electrophoresis. Volume 43:Issue 9/10(2022)
• Page Start: 964
• Page End: 969
• Publication Date: 2022-01-23
• Subjects: Capillary electrophoresis -- Design of experiments -- Enantiomeric purity -- Quality by design -- Tenofovir; Electrophoresis -- Periodicals; Electrophoresis -- Periodicals; 541.372
• DOI: 10.1002/elps.202100345
• Languages: English
• ISSNs: 0173-0835

Abstract

Abstract: A CE method was developed and validated for the assessment of the chiral purity of the drug tenofovir applying a quality by design approach. Following selection of a quaternary ammonium β‐CD as chiral selector, a fractional factorial resolution V+ design was employed for identification of the critical process parameters, while a central composite design served for method optimization. The final method used a 40/50.2 cm, 50 μm id fused‐silica capillary, a BGE composed of a 100 mM sodium phosphate buffer, pH 6.4, containing 45 mg/mL quaternary ammonium β‐CD, an applied voltage of 18 kV, and a capillary temperature of 22°C. Robustness was assessed by a Plackett–Burman design. The method was validated according to guideline Q2(R1) of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use and enabled the determination of the ( S )‐enantiomer of tenofovir at the 0.1% level.