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KMID : 0369820150450030329
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Jorunal of Korean Pharmaceutical Sciences
2015 Volume.45 No. 3 p.329 ~ p.340
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Development and validation of a liquid chromatography?mass spectrometry method for simultaneous determination of metoprolol and telmisartan in rat plasma and its application to pharmacokinetic study
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Nandi Utpal
Dan Shubhasis
Pal Tapan Kumar
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Abstract
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A simple, rapid and sensitive high-performance liquid chromatography?tandem mass spectrometry method has been developed and validated according to the Food and Drug Administration (FDA) guidelines for simultaneous determination of metoprolol and telmisartan in rat plasma using atorvastatin as an internal standard. The analytes were separated on a Gemini C18 column (50 mm × 4.6 mm, 5 μm) with an isocratic mobile phase of methanol?water containing 0.5 % formic acid (9:1, v/v) at a flow rate of 0.5 mL/min. The estimation was carried out by triple quadrupole mass spectrometry using electrospray ionization technique, operating in multiple reaction monitoring and positive ion modes. Simple liquid?liquid extraction was used for sample preparation. Linearity was achieved over the concentration range of 1?500 ng/mL for both the analytes in rat plasma. Results of validation parameters of the method were with the acceptance criteria of the FDA guidelines. The method was found suitable to quantitatively assess the pharmacokinetics of metoprolol and telmisartan in rat following administration of a single oral dose 2.5 and 2 mg/kg body weight, respectively in Wistar albino rat.
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KEYWORD
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Metoprolol, Telmisartan, Liquid chromatography?tandem mass spectrometry, Validation, Pharmacokinetics
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