Determination and pharmacokinetic study of riociguat by UPLC-MS/MS in human plasma

Koçak Ö. F., Albayrak M., Yaman M. E., Atila A., Kadıoğlu Y., Araz Ö.

Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences, cilt.1210, 2022 (SCI-Expanded) identifier identifier identifier

  • Yayın Türü: Makale / Tam Makale
  • Cilt numarası: 1210
  • Basım Tarihi: 2022
  • Doi Numarası: 10.1016/j.jchromb.2022.123454
  • Dergi Adı: Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences
  • Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus, Academic Search Premier, Aerospace Database, BIOSIS, CAB Abstracts, Chemical Abstracts Core, Chimica, Communication Abstracts, Compendex, EMBASE, Food Science & Technology Abstracts, MEDLINE, Metadex, Veterinary Science Database, Civil Engineering Abstracts
  • Anahtar Kelimeler: Riociguat, UPLC-MS, MS, Method Validation, Pulmonary Hypertension
  • Atatürk Üniversitesi Adresli: Evet

Özet

© 2022 Elsevier B.V.Pulmonary hypertension (PH) is frequent in the general population and is linked to an increased risk of death. Riociguat is a kind of endothelin receptor antagonist that is often used to treat PH. For pharmacokinetic studies and the determination of riociguat in PH patients, a new, quick, easy, and sensitive UPLC–MS/MS approach was designed and validated. Riociguat and irbesartan (IS) were detected using ESI in positive ion and multiple reaction monitoring mode, respectively, by monitoring the mass transitions m/z 423.0 → 391.0 and 429.1 → 206.9. A reverse-phase C18 column (5 μm, 4.6 × 150 mm) was used with an isocratic mobile phase of water containing 0.1 % formic acid–acetonitrile (25:75, v/v) at a flow rate of 1 ml/min for chromatographic separation. In the range of 5–400 ng/ml, the calibration curve was linear and had a good correlation coefficient (0.9972). This is the first UPLC–MS/MS technique that has been developed and validated for determining riociguat from human plasma. The developed analytical method was extensively validated for linearity, selectivity, specificity, accuracy, precision, sensitivity, stability, matrix effect and recovery, according to FDA criteria. The devised approach was successfully used for a pharmacokinetic research and riociguat determination in PH patients.