High-Performance Liquid Chromatographic Determination of Memantine in Human Urine Following Solid-Phase Extraction and Precolumn Derivatization

Michail, Karim; Daabees, Hoda G.; Beltagy, Y. A.; Elkhalek, Magdy Abd; Khamis, Mona M.

doi:10.5740/jaoacint.11-080

Cited by 7 publications

(9 citation statements)

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“…[5] Several high-performance liquid chromatography (HPLC) methods have been reported in combination with ultraviolet or fluorescence detection, but these invariably had involved pre-column or post-column derivatization. [6][7][8][9][10][11][12][13][14][15] A few gas chromatography-mass spectrometry and liquid chromatography-mass spectrometry methods have also been reported for quantitation of the drug in biological fluids. [9,[14][15][16][17] Unfortunately, most of them have also involved tedious extraction procedures and even derivatization.…”

Section: Introductionmentioning

confidence: 99%

Quantitation of memantine hydrochloride bulk drug and its tablet formulation using proton nuclear magnetic resonance spectrometry

Sahu

Narayanam

Kurmi

et al. 2016

Magnetic Reson in Chemistry

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The use of quantitative nuclear magnetic resonance spectrometry for the determination of non-UV active memantine hydrochloride with relative simplicity and precision has been demonstrated in this study. The method was developed on a 500 MHz NMR instrument and was applied to determination of the drug in a tablet formulation. The analysis was performed by taking caffeine as an internal standard and D2 O as the NMR solvent. The signal of methyl protons of memantine hydrochloride appeared at 0.75 ppm (singlet) relative to the signal of caffeine (internal standard) at 3.13 ppm (singlet). The method was found to be linear (r(2) = 0.9989) in the drug concentration range of 0.025 to 0.80 mg/ml. The maximum relative standard deviation for accuracy and precision was <2. The limits of detection and quantification were 0.04 and 0.11 mg/ml, respectively. The robustness of the method was revealed by changing nine different parameters. The deviation for each parameter was also within the acceptable limits. The study highlighted possibility of direct determination of memantine hydrochloride in pure form and in its marketed tablet formulation by the use of quantitative NMR, without the need of derivatization, as is the requirement in HPLC studies. Copyright © 2016 John Wiley & Sons, Ltd.

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Section: Introductionmentioning

confidence: 99%

Quantitation of memantine hydrochloride bulk drug and its tablet formulation using proton nuclear magnetic resonance spectrometry

Sahu

Narayanam

Kurmi

et al. 2016

Magnetic Reson in Chemistry

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“…However, the derivatization reaction process of FDNB was more complex, because FDNB is required for an additional process to hydrolyze to dinitrophenol in the acidic conditions, compared to our UV-HPLC method with FMOC derivatization. In addition, although Michail et al (2013) also recently founded a sensitive UV-HPLC method using o-phthalaldehyde in the presence of N-acetyl-L-cystein, tedious sample preparations of solid-phase extraction were still required with a limited application of human urine sample. Again, our developed UV-method with FMOC derivatization is quite simple and effective to be capable of UV detection of the drug, especially for in vitro dissolution samples of memantine hydrochloride.…”

Section: Stabilitymentioning

confidence: 99%

“…So far, it has been reported that memantine was subjected to be pre-derivatized with some reagents including 9-fluorenylmethyl-chloroformate (FMOC) and dansyl chloride etc. in order to be readily detected for UV- (Narola et al 2010;Haen et al 2012;Jalalizadeh et al 2013;Michail et al 2013) or fluorescence- (Higashi et al 2006;Zarghi et al 2010;Xie et al 2011;Puente et al 2011;Toker et al 2011;Hassan et al 2012;Tekkeli and Toker 2013) high performance liquid chromatography (HPLC) in pharmaceutical dosage forms and/or biological samples such as plasma/serum of animals and human. Although previous papers well reported validated data and practical applications including pharmacokinetic studies, most of previous studies likely focus on the development and validation of bio-analytical methods mostly using fluorescence-HPLC, even required by expensive and tedious sample preparations such as liquidliquid extraction or solid-phase extraction.…”

Section: Introductionmentioning

confidence: 99%

Validation and application of a simple reverse phase HPLC method for in vitro dissolution studies of memantine hydrochloride tablet

Maeng

Choi

Jang

et al. 2015

Journal of Pharmaceutical Investigation

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A simple, accurate and cost-effective ultraviolethigh performance liquid chromatography (UV-HPLC) assay method was developed and validated for the determination of derivatized memantine, a representative oral noncompetitive N-methyl-D-aspartate receptor antagonist to treat Alzheimer's disease, in dissolution medium. Optimized derivatization process of memantine was performed with 9-fluorenylmethylchloroformate (FMOC), and injected with the UV-HPLC system for quantitation. Derivatized memantine were separated on a reverse phase C18 column (Shiseido, 250 9 4.6 mm, 5 lm) with a mixture of 50 mM phosphate buffer (pH 4, adjusted with orthophosphoric acid) and Acetonitrile (20:80, v/v), at a flow rate of 2.0 mL/min. UV detection was monitored at 265 nm. The detector response was specific and linear over the concentration range of 1.0-20.0 lg/mL. Validation parameters of derivatized memantine with the sensitivity, selectivity, linearity, accuracy, precision and stability in dissolution medium (pH 1.2) were acceptable based on International Conference on Harmonization Q2 (R1). The assay method validated in this work was successfully applied for a dissolution study of a commercial tablet containing memantine hydrochloride (i.e., Ebixa Ò , 10 mg). Thus, the developed method would be appropriate for routine in vitro dissolution studies of memantine hydrochloride tablet. Keywords Memantine hydrochloride Á Ultraviolet-high performance liquid chromatography (UV-HPLC) Á Derivatization Á 9-Fluorenylmethylchloroformate (FMOC) Á Dissolution ACN Acetonitrile AD Alzheimer's disease FMOC 9-Fluorenylmethyl-chloroformate FDNB 1-Fluoro-2,4-dinitrobenzene HPLC High-performance liquid chromatography LOQ Limit of quantification NMDA N-methyl-D-aspartate QC Quality control RSD Relative standard deviation SPE Solid-phase extraction UV Ultraviolet

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“…Direct UV absorption and fluorescence analysis of memantine is challenging due to absence of chromophoric groups and the weak UV absorbance of the primary amine group. Derivatization reactions were proposed to impart measurable characteristics to mematine to enable UV, fluorescence and liquid chromatographic quantification [2][3][4][5][6][7][8][9][10]. Unfortunately, however, derivatization reactions involve highly reactive compounds that require high precautions and special safety measures.…”

Section: Introductionmentioning

confidence: 99%

3D spongy-like Au film for highly stable solid contact potentiometric ion selective electrode: application to drug analysis

Hussien

Derar

2019

SN Appl. Sci.

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Potentiometric ion selective electrodes with simple design and high potential stability are required for in-line process, clinical and quality control analysis. The objective of this work is to develop a high-surface-area Au nanostructure solidcontact (SC) platform for high stable ion selective electrode for drug analysis. Memantine, a pharmaceutical compound prescribed for Alzheimer's disease, with challenging measurable analytical characteristics, was selected as a model for this purpose. Internal solid-contact with a high surface area was prepared by direct electrochemical deposition of Aunanostructures onto a Pt electrode (500 µm diameter and 3 mm long). The proposed design combines the small size with the high surface area that is necessary for stable potential response. Cyclic voltammetry, impedance electrochemical spectroscopy and chronopotentiometry were used to evaluate electrochemical properties of the Au film. The Au-nanostructure SC electrode was coated with a membrane cocktail containing a lipophilic ion exchanger. The electrode exhibited a Nernstian response (58.5 ± 1 mV/decade) to memantine over a wide concentration range (1 × 10 −5-1 × 10 −2 M). The electrode showed high potential stability (0.03 µV/s), wide pH working range (3.0-8.0) and high selectivity to memantine log k pot i,j ≤ −2.38. The electrode was applied for direct determination of memantine in pharmaceutical dosage form, human urine and surface water with high accuracy (± 2%) and precision (RSD ≤ 1.5%).

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High-Performance Liquid Chromatographic Determination of Memantine in Human Urine Following Solid-Phase Extraction and Precolumn Derivatization

Cited by 7 publications

References 0 publications

Quantitation of memantine hydrochloride bulk drug and its tablet formulation using proton nuclear magnetic resonance spectrometry

Quantitation of memantine hydrochloride bulk drug and its tablet formulation using proton nuclear magnetic resonance spectrometry

Validation and application of a simple reverse phase HPLC method for in vitro dissolution studies of memantine hydrochloride tablet

3D spongy-like Au film for highly stable solid contact potentiometric ion selective electrode: application to drug analysis

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