Tropical Journal of Pharmaceutical Research

Original Research Article | OPEN ACCESS

Quantitation of solifenacin in human plasma using a specific and sensitive liquid chromatography-tandem mass spectrometry technique

Wesam G Ammari

Faculty of Pharmacy and Medical Sciences, Al-Ahliyya Amman University, Jordan;

For correspondence:- Email: wammari@ammanu.edu.jo Tel:+962777488028

Received: 6 January 2015 Accepted: 22 April 2015 Published: 26 May 2015

Citation: Ammari WG. Quantitation of solifenacin in human plasma using a specific and sensitive liquid chromatography-tandem mass spectrometry technique. Trop J Pharm Res 2015; 14(5):845-851 doi: 10.4314/tjpr.v14i5.15

© 2015 The authors.
This is an Open Access article that uses a funding model which does not charge readers or their institutions for access and distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0) and the Budapest Open Access Initiative (http://www.budapestopenaccessinitiative.org/read), which permit unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited..

Abstract

Purpose: The current work validated a high performance liquid chromatography-tandem mass spectrometric (HPLC-MS/MS) bioassay method developed in-house for the quantitation of solifenacin in human plasma.

Methods: Solifenacin was extracted from plasma by a liquid-liquid extraction (LLE) technique using tert-butyl methyl ether. The dry extract was then reconstituted with 200 μL of the mobile phase (acetonitrile-water (80:20, v/v)). Solifenacin-d5 was the internal standard (IS). Elution was carried out on a C18 column at a flow rate of 1 mL/min. The MS/MS employed turbo-ion spray ionization in the positive ion mode. Solifenacin and IS were monitored at a mass to charge ratio (m/z) of 363.4 and 368.4, respectively. Bioassay validation followed International Bioanalytical Method Validation Guidelines.

Results: The validated calibration curves were linear over a range of 0.5 – 60.0 ng/mL (regression factors ≥ 0.9994). Method specificity was established in 6 different human plasma batches. Intra- and inter-day precision and accuracy were within ± 20 % (for lower limit of quantitation (LLOQ)) and ± 15 % (for low, mid and high quality control (QC) levels). Short- and long-term stability was within accepted range.

Conclusion: A specific, accurate and precise HPLC-MS/MS method has been validated for the determination of solifenacin in human plasma.

Keywords: Liquid extraction, Mass spectrometry, Solifenacin, Validation