Simultaneous determination of Avanafil and Dapoxetine in human plasma using liquid chromatography/tandem mass spectrometry (LC-MS/MS) based on a protein precipitation technique

Authors

Ekram Hany Mohamed, The British University in EgyptFollow
Mohamed S. S. Attia, Chemistry Department, Faculty of Science, Ain Shams University, Abbassia, Cairo, 11566, Egypt
Mona N. Abou-Omar,, Department of Chemistry, Ain Shams University, Faculty of Women for Arts, Science and Education, Cairo, Egypt
Abdelaziz M Annadi,, Chemistry Department, Faculty of Science, Ain Shams University, Abbassia, Cairo, 11566, Egypt
Ahmed O. Youssef, Analytical Chemistry Department, Faculty of Science, Ain Shams University, Cairo, Egypt
Mohamed A. AMIN, Department of Chemistry, College of Science, Taif University, P.O. BOX 11099, Taif, 21944, Saudi Arabia
Noha M. El Zahar,, Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Ain Shams University, Organization of African Unity Street, Abassia, Cairo, 11566, Egypt

Document Type

Article

Publication Date

Summer 8-25-2021

Abstract

A rapid and selective LC-MS/MS method is described for the simultaneous assay of Avanafil and Dapoxetine in human plasmaviaa protein precipitation (PP) sample preparation technique. Tadalafil was chosen as the internal standard reaching good recovery and reproducibility while diminishing the effects of the matrix. An Agilent Zorbax Eclipse XDB C18column (4.6 × 50 mm, 1.8 μm) was used for the chromatographic separation and analysis, while 0.1% formic acid : acetonitrile (60 : 40, v/v) was utilized at a flow rate of 0.5 mL min−1. It was revealed that 6 min stop time accomplished the best separation. The assay was linear over the range of 10-6000 ng mL−1for both drugs. The established bio-analytical method validation was demonstrated following US-FDA recommendations including sensitivity, selectivity, linearity, accuracy and precision. Furthermore, other validation parameters were assessed such as the dilution integrity, matrix effect, carryover, and analyte stability during both short- and long-term sample processing and storage. The adopted method was efficaciously applied to a clinical study for the concurrent determination of Avanafil and Dapoxetine in human plas

Recommended Citation

Mohamed, Ekram Hany; Attia, Mohamed S. S.; Abou-Omar,, Mona N.; Annadi,, Abdelaziz M; Youssef, Ahmed O.; AMIN, Mohamed A.; and El Zahar,, Noha M., "Simultaneous determination of Avanafil and Dapoxetine in human plasma using liquid chromatography/tandem mass spectrometry (LC-MS/MS) based on a protein precipitation technique" (2021). Pharmacy. 697.
https://buescholar.bue.edu.eg/pharmacy/697