A validated UPLC–MS/MS method for flibanserin in plasma and its pharmacokinetic interaction with bosentan in rats

Author:

Iqbal Muzaffar12,Ezzeldin Essam12,Rezk Naser L3,Bajrai Amal A4,Al-Rashood Khalid A1

Affiliation:

1. Department of Pharmaceutical Chemistry, College of Pharmacy, King Saud University, PO Box No 2457 Riyadh, Saudi Arabia

2. Bioavailability Laboratory, College of Pharmacy, King Saud University, PO Box No 2457 Riyadh, Saudi Arabia

3. Clinical Laboratory Sciences, College of Applied Medical Sciences, Taibah University, Medina, Saudi Arabia

4. Consultant, Obesity Centre, College of Medicine, King Saud University, Riyadh, Saudi Arabia

Abstract

Aim: The purpose of this study was development, validation and application of ultra-performance liquid chromatography (UPLC)–ESI–MS/MS method for quantitation of flibanserin in plasma samples.Method & results: After extraction of analyte from plasma by diethyl ether, separation was performed on UPLC C18 column using mobile phase composition of 10 mM ammonium formate-acetonitrile (30:70, v/v) by isocratic elution of 0.3 ml/min. The multiple reaction monitoring transitions of m/z 391.13 → 161.04 and 384.20 → 253.06 were used for detection of analyte and internal standard (quetiapine), respectively. The calibration curves were linear (r ≥ 0.995) between 0.22 and 555 ng/ml concentration and all validation results were within the acceptable range as per US FDA guidelines. Conclusion: The assay procedure was fully validated and successfully applied in pharmacokinetic interaction study of flibanserin with bosentan in rats.

Publisher

Future Science Ltd

Subject

Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry

Reference21 articles.

1. Flibanserin in Postmenopausal Women With Hypoactive Sexual Desire Disorder: Results of the PLUMERIA Study

2. FDA Approval of Flibanserin — Treating Hypoactive Sexual Desire Disorder

3. US prescribing information of Addyi (flibanserin) tablets, for oral use: Sprout Pharmaceuticals, Inc (2015). www.accessdata.fda.gov/drugsatfda_docs/label/2015/022526lbl.pdf.

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