PMID: 29474762Feb 24, 2018Paper

QUANTITATIVE DETERMINATION OF RESIDUAL MONOMETHYLAMINE CONTENT IN NEBIVOLOL HYDROCHLORIDE BY HPIC WITH SUPPRESSED CONDUCTIVITY DETECTION

Acta poloniae pharmaceutica
Marzena PodolskaAleksander Mazurek

Abstract

The aim of this paper was to develop a simple analytical method which could be used to determine a synthesis-derived amount of monomethylamine (MMA) residue present in nebivolol hydrochloride. High-performance ion chromatography (HPIC) method with suppressed conductivity detection was used for this purpose. The HPIC analysis was performed with IonPac CS 14 column (250 x 4 mm) containing a macroporous weak cation-exchange stationary phase eluted with 10 mM methanesulfonic acid (MSA). Validation of the method confirmed its selectivity by achieving a satisfactory separation of alkyl- and alkanolamines and metal cations. The method also showed a sufficient precision (RSD < 5.0%) and accuracy (recovery 90-103%). The calibration plot was linear in the range 0.03-2.4 μg/mL of MMA (r² = 0.9997). The calculated limit of quan- tification LOQ was 0.03 μg/mL. Amount of the MMA contained in nebivolol hydrochloride was determined by direct reading from the calibration curve and by the multiple standard additions method. Both methods showed satisfactory precision (RSD < 10.0%) and they can be used to determine the monomethylamine content in the studied active substance.

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