TY  - JOUR
N2  - In the present study, a sensitive and fully validated liquid chromatography with mass spectrometry method was developed for the quantification of three potential genotoxic impurities in rabeprazole drug substance. The separation was achieved on Symmetry C18 column (100 Ã? 4.6 mm, 3.5 μm) using 0.1 formic acid in water as mobile phase A and acetonitrile as mobile phase B in gradient elution mode at 0.5 mL/min flow rate. Triple quadrupole mass detection with electrospray ionization was operated in selected ion recording mode for the quantification of impurities. The calibration curves were demonstrated good linearity over the concentration range of 1.0â??4.5 ppm for O-phenylenediamine, 1.8â??4.5 ppm for 4-nitrolutidine-N-oxide and 1.0â??4.5 ppm for benzyltriethylammonium chloride with respect to 10 mg/mL of rabeprazole. The correlation coefficient obtained in each case was >0.998. The recoveries were found satisfactory over the range between 94.22 and 106.84 for all selected impurities. The method validation was carried out following International Conference on Harmonization guidelines, from which the developed method was able to quantitate the impurities at 1.0 ppm for O-phenylenediamine, 1.8 ppm for 4-nitrolutidine-N-oxide and 1.0 ppm for benzyltriethylammonium chloride. Furthermore, the proposed method was successfully evaluated for the determination of selected impurities from bulk drug and formulation samples of rabeprazole within the acceptable limits. © 2018 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim
IS  - 21
KW  - Aromatic compounds; Chlorine compounds; Liquid chromatography; Mass spectrometry
KW  -  Benzyltriethylammonium chlorides; Correlation coefficient; Genotoxic impurities; Gradient elution mode; International conference on harmonizations; Method validations; Proton pump inhibitors; Rabeprazole
KW  -  Electrospray ionization
KW  -  1
KW  - 2 phenylenediamine; 4 nitrolutidine n oxide; acetonitrile; ammonium derivative; benzyltriethylammonium chloride; formic acid; oxide; rabeprazole; unclassified drug; water; rabeprazole
KW  -  Article; calibration; chemical parameters; concentration (parameters); controlled study; correlation coefficient; drug formulation; drug impurity; drug solubility; electrospray mass spectrometry; limit of detection; limit of quantitation; linear system; liquid chromatography; liquid chromatography-mass spectrometry; maximum allowable concentration; measurement accuracy; measurement precision; priority journal; quantitative analysis; sensitivity analysis; sensitivity and specificity; triple quadrupole mass spectrometry; validation study; chemistry; drug contamination; mass spectrometry
KW  -  Chromatography
KW  -  Liquid; Drug Compounding; Drug Contamination; Mass Spectrometry; Rabeprazole
ID  - scholars9821
Y1  - 2018///
UR  - https://www.scopus.com/inward/record.uri?eid=2-s2.0-85052936385&doi=10.1002%2fjssc.201800626&partnerID=40&md5=68d3b1c02ced0e1d84d15bbf88aa8959
A1  - Yenugu, V.M.R.
A1  - Ambavaram, V.B.R.
A1  - Moniruzzaman, M.
A1  - Madhavi, G.
JF  - Journal of Separation Science
VL  - 41
AV  - none
N1  - cited By 7
TI  - A simple, sensitive, and straightforward LCâ??MS approach for rapid analysis of three potential genotoxic impurities in rabeprazole formulations
SP  - 3966
SN  - 16159306
PB  - Wiley-VCH Verlag
EP  - 3973
ER  -