Capillary electrophoresis method for the determination of (R)-dapoxetine, (3S)-3-(dimethylamino)-3-phenyl-1-propanol, (S)-3-amino-3-phenyl-1-propanol and 1-naphthol as impurities of dapoxetine hydrochloride
| Autor: | Henrik Harnisch, Gerhard K. E. Scriba |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
Quality Control
Benzylamines Resolution (mass spectrometry) 1-Naphthol Clinical Biochemistry Pharmaceutical Science Naphthols Electrolyte Naphthalenes 01 natural sciences Analytical Chemistry chemistry.chemical_compound Capillary electrophoresis Drug Discovery medicine Computer Simulation Spectroscopy Chromatography 010405 organic chemistry 010401 analytical chemistry Electrophoresis Capillary Reproducibility of Results Fractional factorial design Stereoisomerism Dapoxetine 0104 chemical sciences 1-Propanol chemistry Enantiomer Drug Contamination Monte Carlo Method Selective Serotonin Reuptake Inhibitors Tablets medicine.drug |
| Zdroj: | Journal of Pharmaceutical and Biomedical Analysis. 162:257-263 |
| ISSN: | 0731-7085 |
| DOI: | 10.1016/j.jpba.2018.09.039 |
| Popis: | A capillary electrophoresis method was developed and validated for the determination of the purity of dapoxetine with regard to the related substances (3S)-3-amino-3-phenylpropan-1-ol, (3S)-3-(dimethylamino)-3-phenylpropan-1-ol, 1-naphthol and the enantiomer (R)-dapoxetine. The separation was based on a dual selector system, which was optimized by a fractional factorial resolution V + design followed by a central composite face centered design with star distance 1 and Monte Carlo simulations for defining the design space. The optimized background electrolyte consisted of a 50 mM sodium phosphate buffer, pH 6.3, containing 45 mg/mL sulfated γ-cyclodextrin and 40.2 mg/mL 2,6-dimethyl-β-cyclodextrin. Separations were carried out in a 23.5/32 cm, 50 μm fused-silica capillary employing a separation voltage of 9 kV at 15 °C. Following robustness testing using a Plackett-Burman design the method was validated according to the International Council on Harmonization guideline Q2(R1) in the range of 0.05–1.0% relative to the dapoxetine concentration. The method was applied to the analysis of drug substance and a commercial tablet. Data regarding the enantiomeric purity of dapoxetine obtained by the capillary electrophoresis assay were comparable to the data obtained by an enantioselective HPLC method. |
| Databáze: | OpenAIRE |
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