کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
11027367 | 1666301 | 2019 | 22 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
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
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کلمات کلیدی
موضوعات مرتبط
مهندسی و علوم پایه
شیمی
شیمی آنالیزی یا شیمی تجزیه
پیش نمایش صفحه اول مقاله
چکیده انگلیسی
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 Vâ+âdesign 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 50âmM sodium phosphate buffer, pH 6.3, containing 45âmg/mL sulfated γ-cyclodextrin and 40.2âmg/mL 2,6-dimethyl-β-cyclodextrin. Separations were carried out in a 23.5/32âcm, 50âμmâfused-silica capillary employing a separation voltage of 9âkV at 15â°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.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical and Biomedical Analysis - Volume 162, 5 January 2019, Pages 257-263
Journal: Journal of Pharmaceutical and Biomedical Analysis - Volume 162, 5 January 2019, Pages 257-263
نویسندگان
Henrik Harnisch, Gerhard K.E. Scriba,