Measurement of fexofenadine concentration in micro‐sample human plasma by a rapid and sensitive LC‐MS/MS employing protein precipitation: application to a clinical pharmacokinetic study

Guo, Daoxia; Zou, Jianjun; Zhu, Yubing; Lei, Sheng; Fan, Hongwei; Qin, Qian

doi:10.1002/bmc.1296

Cited by 20 publications

(18 citation statements)

References 12 publications

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“…These methods include high performance liquid chromatography (HPLC) (Uno et al, 2004;Pankaniya et al, 2013;Krakus et al, 2008), capillary electrophoresis (Breier et al, 2005;Mikus et al, 2005), mass spectrometric methods (Guo et al, 2010;Hofmann et al, 2002), spectrophotometric methods (Gazy et al, 2002;Naravana and Veena, 2010;Ashour et al, 2013), and chemiluminescence (CL) method (Al-Lawati et al, 2011).…”

Section: Introductionmentioning

confidence: 99%

Terbium sensitized luminescence for the determination of fexofenadine in pharmaceutical formulations

Al-Kindy

Al-Shamalani

Suliman

et al. 2019

Arabian Journal of Chemistry

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A sensitive and specific luminescence method for the determination of Fexofenadine (FEX), in pharmaceutical formulations is reported. The method is based on the sensitization of terbium (Tb 3+ ) by complex formation with FEX. The luminescence signal for Tb-FEX complex is greatly enhanced by the addition of triethylamine (ET 3 N) and zinc nitrate in methanol solution.Monitoring of the signal is accomplished when the instrument is in the phosphorescence mode with the excitation and emission wavelengths set at k ex = 220 nm and k em = 550 nm respectively. Optimum conditions for the formation of the complex in methanol were 2.25 · 10 À6 M of Tb 3+ , 5.00 · 10 À6 M of Et 3 N and Zn 2+ which allows for the determination of 10-800 ppb of FEX in the batch mode with a detection limit of 0.3 ppb. The proposed method was successfully applied for the determination of FEX in pharmaceutical formulations. ª 2015 The Authors. Production and hosting by Elsevier B.V. on behalf of King Saud University. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

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Section: Introductionmentioning

confidence: 99%

Terbium sensitized luminescence for the determination of fexofenadine in pharmaceutical formulations

Al-Kindy

Al-Shamalani

Suliman

et al. 2019

Arabian Journal of Chemistry

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“…A number of methods for quantification of FXN can be found in the literature. Some of them are liquid chromatography methods developed for determination of this drug in biologic fluids or pharmaceutical dosage forms, by the mass spectrometry, [6][7][8] ultraviolet detection as single or binary dosage forms, [9][10][11][12] and fluorescence detection. [13][14][15] Few methods were reported for the determination of FXN using spectrophotometric method.…”

Section: Introductionmentioning

confidence: 99%

Application of SDS Micelles as Carriers for Reliable Determination of Fexofenadine and Its Impurities in Bulk and Pharmaceutical Formulations by Capillary Micellar Electrophoresis

Javid

Shafaati

Zarghi

2013

Journal of Liquid Chromatography & Related Technologies

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& A reversed-polarity capillary electrophoretic method based on application of sodium dodecyl sulfate (SDS) micelles as the carriers was developed for separation and determination of Fexofenadine (FXN) hydrochloride and its three major structural impurities in bulk and a tablet dosage form. CE analysis was performed using untreated fused-silica capillary of 50 lm internal diameter and 75-cm total length (25-cm effective length). The voltage applied of À25 kV at 25 C, and the detection wavelength was set at 225 nm. The running buffer was a 150 mM phosphate buffer at pH ¼ 3.0, containing 22 % v=v acetonitrile and 25 mmol SDS. Terfenadine was used as the internal standard (IS). The proposed method was found selective for determination of the main drug and its major impurities. The limit of quantification (LOQ) for FXN and impurities D10, D11, and A were found 70 lg=mL, 50 lg=mL, 80 lg=mL, and 100 lg=mL, respectively. The regression data obtained from the calibration plots indicated linear relationship (r 2 ¼ 0.997) over the concentration range of 70-500 lg=mL of FXN. Repeatability and reproducibility of the method, assessed as intra-day and inter-day variation and expressed as RSD ( %), were less than 4 % for relative peak area. Then, the method was applied for the determination of FXN in bulk and a tablet dosage form.

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“…Among which are those using LC-MS/MS [7], ultraviolet detection [8] and fluorescence detection [9]. Few methods reported the quantitation of FEX in pharmaceutical dosage forms using spectrophotometric methods [10], LC methods with ultraviolet detection [11-13], and capillary electrophoresis [14,15].…”

Section: Introductionmentioning

confidence: 99%

Development of validated stability-indicating chromatographic method for the determination of fexofenadine hydrochloride and its related impurities in pharmaceutical tablets

Maher

Sultan

Olah

2011

Chemistry Central Journal

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A simple reversed phase high performance liquid chromatographic method with diode array detector (HPLC-DAD) has been developed and subsequently validated for the determination of fexofenadine hydrochloride (FEX) and its related compounds; keto fexofenadine (Impurity A), meta isomer of fexofenadine (Impurity B), methyl ester of fexofenadine (Impurity C) in addition to the methyl ester of ketofexofenadine (Impurity D). The separation was based on the use of a Hypersil BDS C-18 analytical column (250 × 4.6 mm, i.d., 5 μm). The mobile phase consisted of a mixture of phosphate buffer containing 0.1 gm% of 1-octane sulphonic acid sodium salt monohydrate and 1% (v/v) of triethylamine, pH 2.7 and methanol (60:40, v/v). The separation was carried out at ambient temperature with a flow rate of 1.5 ml/min. Quantitation was achieved with UV detection at 215 nm using lisinopril as internal standard, with linear calibration curves at concentration ranges 0.1-50 μg/ml for FEX and its related compounds. The optimized conditions were used to develop a stability-indicating HPLC-DAD method for the quantitative determination of FEX and its related compounds in tablet dosage forms. The drugs were subjected to oxidation, hydrolysis, photolysis and heat to apply stress conditions. Complete separation was achieved for the parent compounds and all degradation products. The method was validated according to ICH guidelines in terms of accuracy, precision, robustness, limits of detection and quantitation and other aspects of analytical validation.

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Measurement of fexofenadine concentration in micro‐sample human plasma by a rapid and sensitive LC‐MS/MS employing protein precipitation: application to a clinical pharmacokinetic study

Cited by 20 publications

References 12 publications

Terbium sensitized luminescence for the determination of fexofenadine in pharmaceutical formulations

Terbium sensitized luminescence for the determination of fexofenadine in pharmaceutical formulations

Application of SDS Micelles as Carriers for Reliable Determination of Fexofenadine and Its Impurities in Bulk and Pharmaceutical Formulations by Capillary Micellar Electrophoresis

Development of validated stability-indicating chromatographic method for the determination of fexofenadine hydrochloride and its related impurities in pharmaceutical tablets

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