Sensitive determination of trimetazidine in spiked human plasma by HPLC with fluorescence detection after pre-column derivatization with 9-fluorenylmethyl chloroformate

Khedr, Alaa; Sheha, Mahmoud; Darwish, Ibrahim A.

doi:10.1016/j.jchromb.2007.06.036

Cited by 12 publications

(11 citation statements)

References 14 publications

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“…Several methods are reported for determination of TMZ in different biological samples such as human plasma (de Jager et al, ; Ding, Gong, Chu, Hu, & Zheng, ; Grabowski et al, ; Helmy & Mansour, ; Jiao et al, ; Khedr, Sheha, & Darwish, ; Liu et al, ; Lv et al, ; Medvedovici, Albu, Georgiţ, & David, ; Mistri, Jangid, & Shrivastav, ; Ozbay, Unal, & Erol, ; Wang, Sun, Rong, Tang, & He, ; Zhang et al, ; Zhou et al, ; Zou, Dai, Wang, Zhu, & Fan, ), human serum (Chowdhury et al, ), rat plasma (Xiong & Yang, ; Xiong, Yang, & Zhai, ), and pig and dog plasma (Génissel, Chodjania, Demolis, Ragueneau, & Jaillon, ). Mainly, high‐performance liquid chromatography (HPLC) with fluorescence (Khedr et al, ), electrochemical (Grabowski et al, ) and UV (Chowdhury et al, ; Helmy & Mansour, ; Lv et al, ) detection, liquid chromatography–mass spectrometry (LC–MS) (de Jager et al, ; Ding et al, ; Jiao et al, ; Ozbay et al, ; Wang et al, ) and liquid chromatography–tandem mass spectrometry (LC–MS/MS) (Liu et al, ; Medvedovici et al, ; Mistri et al, ; Xiong et al, ; Xiong & Yang, ; Zhou et al, ; Zou et al, ) have been the preferred techniques for quantification of TMZ in these matrices. In addition, a few other reports present the use of gas chromatography with nitrogen–phosphorous (Barre et al, ) and mass detection (Fay, Michel, Goupit, Harpey, & Prost, ).…”

Section: Introductionmentioning

confidence: 99%

Overcoming interference of plasma phospholipids using HybridSPE for the determination of trimetazidine by UPLC–MS/MS

Vanol

Yadav

Sanyal

et al. 2017

Biomedical Chromatography

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An improved, precise and reliable ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method has been developed for the quantification of trimetazidine, using trimetazidine-d8 as the internal standard (IS). Interference owing to plasma phospholipids during sample preparation was overcome using a hybrid solid-phase extraction-phospholipid ultra cartridge. The mean extraction recovery of trimetazidine (98.66%) and trimetazidine-d8 (97.63%) from spiked plasma was consistent and reproducible. Chromatographic analysis was performed on a UPLC Ethylene Bridged Hybrid (BEH) C18 (50 × 2.1 mm, 1.7 μm) column with isocratic elution using acetonitrile-5 mm ammonium formate, pH 3.5 (40:60, v/v) as the mobile phase. The parent → product ion transitions for trimetazidine (m/z 267.1 → 181.1) and trimetazidine-d8 (m/z 275.2 → 181.1) were monitored on a triple quadrupole mass spectrometer with electrospray ionization functioning in the positive multiple reaction monitoring mode. The linearity of the method was established in the concentration range of 0.05-100 ng/mL for trimetazidine. The intra-batch and inter-batch accuracy and precision (CV) were 97.3-103.1 and 1.7-5.3%, respectively. Qualitative and quantitative assessment of matrix effect showed no interference of endogenous/exogenous components. The developed method was used to measure plasma trimetazidine concentration for a bioequivalence study with 12 healthy subjects.

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Section: Introductionmentioning

confidence: 99%

Overcoming interference of plasma phospholipids using HybridSPE for the determination of trimetazidine by UPLC–MS/MS

Vanol

Yadav

Sanyal

et al. 2017

Biomedical Chromatography

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“…The sensitivity of the method was allowed for pharmacokinetic study in human after the extraction process (Courte and Bomet 1981). In the recently published work, Khedr et al (2007) described a LC with fluorescence detection method for the sensitive determination of TMZ in spiked human plasma after precolumn derivatization with 9‐fluorenylmethyl chloroformate. The proposed method comprises the precolumn derivatization with 9‐fluorenylmethyl chloroformate and injection onto a reversed‐phase column.…”

Section: Discussionmentioning

confidence: 99%

“…The sensitivity was reported as 1.5 ng/mL. All necessary validation parameters were given (Khedr et al 2007).…”

Section: Hplc Methodsmentioning

confidence: 99%

Trimetazidine Revisited: A Comprehensive Review of the Pharmacological Effects and Analytical Techniques for the Determination of Trimetazidine

Onay-Beşi̇kçi̇

Özkan

2008

Cardiovascular Therapeutics

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Trimetazidine (TMZ) is an effective and well‐tolerated antianginal drug that possesses protective properties against ischemia‐induced heart injury. Growing interest in metabolic modulation in recent years urged an up‐to‐date review of the literature on TMZ. This review consists of two major sections: (1) comprehensive and critical information about the pharmacological effects, mechanism of action, pharmacokinetics, side effects, and current usage of TMZ, and (2) developments in analytical techniques for the determination of the drug in raw material, pharmaceutical dosage forms, and biological samples.

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“…[4][5] For these clinical successes, trimetazidine (TMZ) has become unique among the antianginal agents, and it has been clinically used throughout many countries worldwide. [6][7] Because of its high solubility, short half-life and therapeutic use in chronic diseases, Trimetazidine is considered as oral modified release dosage forms 8 because of its high solubility, short half-life and therapeutic use in chronic diseases. Modified-release (MR) formulation are aimed to maintain the therapeutic serum concentration with less fluctuation.…”

Section: Introductionmentioning

confidence: 99%

“…12 Several methods are described in the literature for the quantitative analysis of Trimetazidine in serum. [13][14][15] Some authors reported the use of fluorescence detector 7 ; while others reported the use of mass spectroscopy 13,14 which is not available in all laboratories for routine analysis. Hence, the aims of the present study were to develop and validate a simple and rapid RP-HPLC method for the determination of trimetazidine in human serum samples with good resolution having the desired sensitivity when applying to a pharmacokinetic study of trimetazidine in healthy Bangladeshi male volunteers.…”

Section: Introductionmentioning

confidence: 99%

Validation and Optimization of a Simple RP-HPLC Method for Determination of Trimetazidine in Human Serum and its Application in a Pharmacokinetic Study with Healthy Bangladeshi Male Volunteers

Chowdhury

Ullah

Maruf

et al. 2012

Dhaka Univ. J. Pharm. Sci

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Abstract:Trimetazidine is an effective and well-tolerated antianginal drug. In the present study, a simple, sensitive and specific liquid chromatography (HPLC) method with UV detection was developed and validated for the quantification of trimetazidine in human serum samples using caffeine as internal standard. Protein precipitation method with methanol was employed in the extraction of trimetazidine and caffeine from biological matrix. The chromatographic separation was accomplished on Xterra C 18 Column with a mobile phase consisting 0.01 M potassium dihydrogen phosphate buffer (pH 4.16 ± 0.01 adjusted with orthophosphoric acid, with a solvent system of triethanolamine and acetonitrile (90:10) at a flow rate of 1.0 ml/min. The chromatogram was monitored at a wavelength of 207 nm. The method was validated over a linear concentration range of 5-200 ng/ml and limit of quantification (LOQ) was 5.0 ng/ml with a coefficient of correlation (r 2 ) ≥ 0.996. The intra-day and inter-day precision expressed as relative standard deviation was 3.40%-11.63% and 1.30%-10.21%, respectively. The average recovery of trimetazidine from serum was 97.44%. The method was successfully applied to a pharmacokinetic study after oral administration of modified release trimetazidine hydrochloride tablet (35 mg) in healthy Bangladeshi volunteers.

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Sensitive determination of trimetazidine in spiked human plasma by HPLC with fluorescence detection after pre-column derivatization with 9-fluorenylmethyl chloroformate

Cited by 12 publications

References 14 publications

Overcoming interference of plasma phospholipids using HybridSPE for the determination of trimetazidine by UPLC–MS/MS

Overcoming interference of plasma phospholipids using HybridSPE for the determination of trimetazidine by UPLC–MS/MS

Trimetazidine Revisited: A Comprehensive Review of the Pharmacological Effects and Analytical Techniques for the Determination of Trimetazidine

Validation and Optimization of a Simple RP-HPLC Method for Determination of Trimetazidine in Human Serum and its Application in a Pharmacokinetic Study with Healthy Bangladeshi Male Volunteers

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