Quantitation of Solifenacin in Human Plasma using a Specific and Sensitive Liquid Chromatography-Tandem Mass Spectrometry Technique
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 usi...
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Veröffentlicht in: | Tropical journal of pharmaceutical research 2015-05, Vol.14 (5), p.845 |
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Sprache: | eng |
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Zusammenfassung: | 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 tertbutyl methyl ether. The dry
extract was then reconstituted with 200 μL of the mobile phase
(acetonitrilewater (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. |
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ISSN: | 1596-5996 1596-9827 |
DOI: | 10.4314/tjpr.v14i5.15 |