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Simultaneous determination and determination of sildenafil and its active metabolite in human plasma using LC-MS/MS method.
- Source :
-
Biomedical chromatography : BMC [Biomed Chromatogr] 2020 Oct; Vol. 34 (10), pp. e4927. Date of Electronic Publication: 2020 Jul 07. - Publication Year :
- 2020
-
Abstract
- A sensitive and selective high-performance liquid chromatography-tandam mass spectrometry (LC-MS/MS) method was developed and validated for the simultaneous quantification of sildenafil and its metabolite N-desmethyl sildenafil in human plasma. Sildenafil-d8 was used as an internal standard. The analytes were extracted by precipitation extraction and chromatographed on a C <subscript>18</subscript> column using mobile phase A of water (containing 0.1% formic acid) and mobile phase B of acetonitrile (containing 0.1% formic acid) with gradient elution. Quantification was done using multiple reaction monitoring mode to monitor the precursor-to-product ion transitions of m/z 475.4 → m/z 283.3 for sildenafil, m/z 461.4 → m/z 283.2 for N-desmethyl sildenafil and m/z 483.3 → m/z 108.1 for IS in positive ionization mode. The calibration curve was established over the range of 2.00-1,000 ng/ml and the correlation coefficient was >0.99. The intra-day and inter-day relative standard deviations were <6.5% for sildenafil and 6.3% for N-desmethyl sildenafil respectively. Accuracy determinaed at four concentrations was 86.50-105.67% for sildenafil and 96.83-114.40% for N-desmethyl sildenafil. This method was successfully applied to a pharmacokinetic description of sildenafil and the effect of food intake on the pharmacokinetics of sildenafil was also demonstrated in healthy Chinese volunteers.<br /> (© 2020 John Wiley & Sons, Ltd.)
Details
- Language :
- English
- ISSN :
- 1099-0801
- Volume :
- 34
- Issue :
- 10
- Database :
- MEDLINE
- Journal :
- Biomedical chromatography : BMC
- Publication Type :
- Academic Journal
- Accession number :
- 32562289
- Full Text :
- https://doi.org/10.1002/bmc.4927