Quantitative determination of residual monomethylamine content in nebivolol hydrochloride by HPIC with surppressed conductivity detection
PBN-AR
Instytucja
Narodowy Instytut Leków
Informacje podstawowe
Główny język publikacji
en
Czasopismo
ACTA POLONIAE PHARMACEUTICA DRUG RESEARCH (15pkt w roku publikacji)
ISSN
0001-6837
EISSN
Wydawca
DOI
URL
Rok publikacji
2017
Numer zeszytu
Strony od-do
67-72
Numer tomu
74
Identyfikator DOI
Liczba arkuszy
0.00
Słowa kluczowe
angielski
monomethylamine (MMA)
nebivolol hydrochloride
HPIC
suppressed conductivity detection
Streszczenia
Język
angielski
Treść
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-per-formance ion chromatography (HPIC) method with suppressed conductivity detection was used for this pur-pose. The HPIC analysis was performed with IonPac CS14 column (250 ◊ 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 90ñ103%). 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.
Cechy publikacji
oryginalny artykuł naukowy
Inne
System-identifier
PX-594a73bdd5dea028a3d59a71