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

Abstract

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

Cefdinir Solid Dispersion Composed of Hydrophilic Polymers with Enhanced Solubility, Dissolution, and Bioavailability in Rats

“…Speed of the paddle was adjusted to 50 rpm. CSDs or cefdinir powder filled in a gelatin capsule shell (#0), equivalent to cefdinir amount of 100 mg, was prepared and placed into a dissolution tester (Varian VK7000, Varian Inc., Santa Clara, CA, USA) [ 24 , 25 ]. At pre-determined intervals, aliquot (5 mL) of the media was collected and filtered through a membrane filter (0.45 μm pore size).…”

Optimization of o‐phtaldialdehyde/2‐mercaptoethanol postcolumn reaction for the hydrophilic interaction liquid chromatography determination of memantine utilizing a silica hydride stationary phase

“…To apply UV/VIS or fluorescence HPLC detection of memantine, the derivatization step is required. Fluorescence detection has been used after precolumn derivatization using o‐phthaldialdehyde (OPA) , 4‐fluoro‐7‐nitro‐2,1,3‐benzoxadiazole , (2‐naphthoxy)acetyl chloride , dansyl chloride , fluorescamine , 4‐(4,5‐diphenyl‐1H‐imidazol‐2‐yl)benzoyl chloride , and 9‐fluorenylmethyl chloroformate . The RP‐HPLC using UV detection was applied for ME derivative with anthraquinone‐2‐sulfonyl chloride , 1‐fluoro‐2,4‐dinitrobenzene , 9‐fluorenylmethyl chloroformate , phenoxy acetyl chloride , and (2‐napthoxy)acetyl chloride .…”

Development of a novel, fast, simple, nonderivative HPLC method with direct UV measurement for quantification of memantine hydrochloride in tablets

“…From the category of non-derivative HPLC techniques, most frequently used detectors are: RID suggested by Chen et al [9], Reddy and Rao [10], Sawant and Mane [11], Sawant et al [12], and Beccera et al [13], ELSD suggested by Zhou et al [14], and Rao et al [15], MS suggested by Reddy and Rao [10] and Chavali et al [16], while CAD was used by Rystov et al [17] and Brondi et al [18]. The most utilized analytical technique was HPLC with some derivatization technique for modification of the memantine chemical structure for enabling its UV or fluorescent response, for example, using previous treatment with FMOC (9-fluorenylmethyl chloroformate): Narola et al [19] and Mokkale et al [20], or with 1-Fluoro-2,4-dinitrobenzene: Jalalizadeh et al [21] and Maeng et al [22], 4-(N-Chloroformylmethyl-N-methyl)amino-7-N,N-dimethylaminosulphonyl 2,1,3benzoxadiazole (DBD-COCL): Prapatong et al [23] and with o-phthaldialdehyde (OPA): Zarghi et al [24]. There are also HPLC methods with direct UV detection, without prior derivatization: Sujana et al [25], Rambabu et al [26], Thangabalan et al [27], Sivangaraju and Jayarao [28], Amena and Rizvan [29], Jeevitha and Pandey [30], Ravikumar et al [31], Phanshiri et al [32], Ganta and Viduadhara [33], Kumar et al [34], and Anees et al [35].…”