Rapid HILIC Method for Assay and Dissolution Analysis of Rivastigmine Hydrogen Tartrate from Hydrophilic Matrix
Fatima Rosangela de Souza Saraiva, Thamiris Yumi Inoue, Sabrina de Santana Camargo, Angela Malheiros, Ruth Meri Lucinda da Silva and Tania Mari Belle BresolinAffiliation:
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.
AbstractWe 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.
Analytical validation, dissolution test, hydrophilic interaction chromatography, HPLC-UV, hydrophilic matrix, rivastigmine tartrate.
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