Simultaneous determination of telmisartan and amlodipine in human plasma by LC–MS/MS and its application in a human pharmacokinetic study

Abstract

A rapid and sensitive liquid chromatography–tandem mass spectrometric (LC–MS/MS) assay method has been developed and fully validated for the simultaneous quantification of telmisartan and amlodipine in human plasma. Carbamazepine was used as an internal standard. Analytes and the internal standard were extracted from human plasma by solid-phase extraction technique using Waters Oasis® HLB 1 cm3 (30 mg) extraction cartridge. The reconstituted samples were chromatographed on a Hypurity advance C18 column (50 mm×4.6 mm, 5 μm) using a mixture of acetonitrile–5 mM ammonium acetate buffer (pH-4.0) (50:50, v/v) as the mobile phase at a flow rate of 0.8 mL/min. The calibration curve obtained was linear (r≥0.99) over the concentration range of 2.01–400.06 ng/mL for telmisartan and 0.05–10.01 ng/mL for amlodipine. Method validation was performed as per FDA guidelines and the results met the acceptance criteria. A run time of 2.5 min for each sample made it possible to analyze more than 400 human plasma samples per day. The proposed method was found to be applicable to clinical studies.

Bioanalytical method development and validation of simultaneous analysis of telmisartan and hydrochlorthiazide in human plasma using LC-MS/MS

“…Reconstituted the dried residue with 500μl of www.ijbio.com 4864 reconstitution solution and transferred into vials for analysis using LC-MS/MS system. [10,11] Bioanalytical method validation studies The validation for a bioanalytical procedure is to demonstrate the performance and reliability of the method. The fundamental parameter to ensure the acceptability of a performance of abioanalytical method validation are accuracy, precision, selectivity, sensitivity, reproducibility and stability…”

“…Samples were considered to be stable if assay values were within the acceptable limits of accuracy (±15% SD) and precision (≤15% RSD). [10][11][12][13][14][15] …”

Optimization of chromatography to overcome matrix effect for reliable estimation of four small molecular drugs from biological fluids using LC–MS/MS

“…For RIV, several analytical techniques such as voltammetry (Arvand & Fallahi, ), capillary electrophoresis (Nicolaou & Kapnissi‐Christodoulou, ), micellar electrokinetic chromatography (Hsieh, Yang, Yeh, Lin, & Chen, ), HPLC–UV (Amini & Ahmadiani, ; Mirparizi, Rajabi, & Asghari, ) and LC–MS/MS (Bhatt et al, ; Frankfort et al, ; Pommier & Frigola, ; Trivedi, Upadhyay, Yadav, Shrivastav, & Sanyal, ) have been used for its estimation in human plasma. Methods for the analysis of TEL in human plasma include HPLC–fluorescence (Zhang et al, ), LC–MS/MS (Chen et al, ; Ferreirós, Dresen, Alonso, & Weinmann, ; Gupta, Jain, Lukram, Agarwal, & Dwivedi, ; Hempen, Gläsle‐Schwarz, Kunz, & Karst, ; Li et al, ; Ravi, Inamadugu, Pilli, Sreenivasulu, & Ponneri, ; Yan et al, ; Zhang et al, ) and ultraperformance liquid chromatography–tandem mass spectrometry (UPLC–MS/MS) (De Nicolò et al, ; Zargar & Wani, ). Mainly immunoassays (Ansermot et al, ; Brown, Gonde, Adams, & Tredger, ; Westley, Taylor, Salm, & Morris, ) and LC–MS/MS (Ansermot et al, ; Bittersohl, Schniedewind, Christians, & Luppa, ; Bogusz et al, ; Capron et al, ; Ceglarek et al, ; Hétu, Robitaille, & Vinet, ; Hoogtanders et al, ; Koster, Dijkers, & Uges, ; Salm, Taylor, & Rooney, ; Stienstra, Sikma, Van Dapperen, de Lange, & van Maarseveen, ) or UPLC–MS/MS (Tszyrsznic et al, ; Upadhyay, Trivedi, Shah, Yadav, & Shrivastav, ) based methods have been employed for the determination of TAC in blood samples.…”

Development and Validation of Liquid Chromatography - Tandem Mass Spectrometry Method for Determination of Amlodipine in Human Plasma and Its Application

“…The determination of amlodipine level in biological samples has been reported with high performance liquid chromatography with ultraviolet (HPLC-UV) [6][7][8][9] , and mass spectrometric detector [10][11][12][13][14] . Although several methods have been reported for the determination of amlodipine in plasma, these methods have low sensitivity and narrow range of linearity [10][11][12][13][14] .…”

“…Although several methods have been reported for the determination of amlodipine in plasma, these methods have low sensitivity and narrow range of linearity [10][11][12][13][14] . These are important parameters, especially when the determination is performed in clinical samples retrieved from subjects who took the drug at low dose.…”