Current Pharmaceutical Analysis

Anastasios Economou
Department of Chemistry
Laboratory of Analytical Chemistry
University of Athens
Athens
Greece
Email: cpa@benthamscience.org

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Rapid HILIC Method for Assay and Dissolution Analysis of Rivastigmine Hydrogen Tartrate from Hydrophilic Matrix

Author(s): Fatima Rosangela de Souza Saraiva, Thamiris Yumi Inoue, Sabrina de Santana Camargo, Angela Malheiros, Ruth Meri Lucinda da Silva and Tania Mari Belle Bresolin

Affiliation: Post-Graduation Program of Pharmaceutical Science, Universidade do Vale do Itajai, Rua Uruguai, 458, Bloco F6, p.o. box 360, CEP 88 302 202, Itajai, Santa Catarina, Brazil.

Keywords: Analytical validation, dissolution test, hydrophilic interaction chromatography, HPLC-UV, hydrophilic matrix, rivastigmine tartrate.

Graphical Abstract:


Abstract:

We developed and validated a rapid hydrophilic interaction chromatography (HILIC) method using a core-shell column in a conventional HPLC to assess the dissolution profile of rivastigmine hydrogen tartrate (RHT, 6 mg) from hydrophilic matrix controlled-release tablets. The dissolution profile was determined from 10-360 min in a USP dissolution apparatus II using water at 37 °C at 50 rpm. The chromatographic separation was performed over 5 min using a Kinetex® (100 x 4.6 mm, 2.6 μm) HILIC column and an isocratic mobile phase consisting of 80:20 acetonitrile:10 mM pH 5.8 ammonium acetate buffer at 30 ºC. The flow rate was 2.0 mL min-1 and the detection wavelength was 217 nm. The method was linear over a range of 1-30 μg mL-1. The intra- and inter-day precision was < 4.0% RSD for the assay and < 15% RSD for the dissolution test. The methods exhibited good recovery (> 90% in the assay and > 95.0% in the dissolution test). The separation method tolerated small variations in flow and temperature. These techniques may be used as a rapid and accurate assay of RHT in hydrophilic matrixes, and to assess the dissolution profile of the drug in modified pharmaceutical dosage form.

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Article Details

VOLUME: 10
ISSUE: 3
Page: [169 - 174]
Pages: 6
DOI: 10.2174/1573412910666140524003218