Simultaneous Determination of Sildenafil, Tadalafil, and Vardenafil in Pharmaceutical Preparations by High-Temperature Gas Chromatography/Mass Spectrometry

摘要: Sildenafil (SD), tadalafil (TD), and vardenafil (VD) are drugs used to treat erectile dysfunction (ED). Pharmaceutical counterfeiting-related SD, TD, VD compounds becoming a critical problem due their harmful side-effects. Especially, SD TD two major counterfeit ED in South Korea. In this study, new high-temperature gas chromatography/mass spectrometry (HTGC/MS) method was developed for the rapid determination of pharmaceutical preparations. A HT GC column introduced analysis high molecular weight boiling point compounds. High-speed centrifugation led shortened time results. Calibration curves were linear (R2 ≥ 0.9972) over concentration ranges 12.5–100 µg mg−1 VD, 25–175 SD. The intra- inter-day precisions within 7.5 %, while accuracies ranged from –3.0 8.0 %. limits quantification 0.7 (SD TD) 0.13 (VD). recoveries range 87.3–102.4 accurate both routine quantitative measurement preparations as well screening suspected