Open AccessMethod Development and Validation for Quantification of Potential Genotoxic Impurity, PyCl in Lansoprazole Hydrochloride using Liquid Chromatography Combined with Mass Spectrometry
Author(s) -
C. Purushotham Reddy,
G. Gopala Rao,
K. Ramakrishna,
Kollipara Mohan Rao
Publication year - 2021
Publication title -
asian journal of chemistry/asian journal of chemistry
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.145
H-Index - 34
eISSN - 0975-427X
pISSN - 0970-7077
DOI - 10.14233/ajchem.2021.23135
Subject(s) - chemistry , chromatography , lansoprazole , detection limit , formic acid , selected reaction monitoring , liquid chromatography–mass spectrometry , mass spectrometry , high performance liquid chromatography , analyte , tandem mass spectrometry , analytical chemistry (journal) , omeprazole , medicine
A sensitive and robust high performance liquid chromatography combined with tandem massspectrometry (LC-MS/MS) method was developed and validated for the determination of potentialgenotoxic impurity (PGI), 2-(chloromethyl)-3-methyl-4-(2,2,2-trifluoroethoxy)-pyridine hydrochloride(PyCl) in lansoprazole as per ICH Q2 guideline. In this method, PyCl and lansoprazole werewell-separated from each other on Acquity UPLC BEH-C18 column (50 × 4.6 mm × 1.7 μ) in agradient elution mode with the mobile phase consisting of 0.1% formic acid in water (mobile phase-A)and acetonitrile (mobile phase-B) at a flow rate of 0.4 mL/min. For the quantitation of Py-Cl, selectiveion monitoring (SIM) mode was used with m/z 240 ion in LC-MS method. The validated method wasfound to be precise, accurate and linear from the range of LOQ level to 150% with respect to sampleconcentration and the correlation co-efficient was found to be 0.998. Limit of detection (LOD) andlimit of quantifications (LOQ) were found to be 0.000012 and 0.4 mg/mL, respectively. Thevalidated method was found to be sensitive and the recoveries were found to be well within the range from83.4% to 95.9% for Py-Cl. Further, the solution stability was also established as the same were found tobe stable upto 24 h.