Analytical quality by design approach for the determination of imidazole in sildenafil API and its formulations using zwitterionic HILIC stationary phase

Herein, the development of a HILIC method for the determination of imidazole (Imp E) in sildenafil citrate API and its final formulations is reported. The main goal of this study was to develop a robust, application-specific HPLC method according to the Analytical Quality by Design principles for th...

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Veröffentlicht in:	Journal of pharmaceutical and biomedical analysis 2023-02, Vol.224, p.115186-115186, Article 115186
Hauptverfasser:	Ntontis, Stefanos, Tsanaktsidou, Eleni, Tzanavaras, Paraskevas D., Kachrimanis, Kyriakos, Markopoulou, Catherine K., Zacharis, Constantinos K.
Format:	Artikel
Sprache:	eng
Schlagworte:	Accuracy profiles Analytical quality by design Chromatography, High Pressure Liquid - methods Formulation High Pressure Liquid Chromatography Imidazole Imidazoles Limit of Detection Reproducibility of Results Sildenafil Sildenafil Citrate
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