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Development and validation of LC–MS method for the determination of heptaethylene glycol monomethyl ether in benzonatate bulk drugs
Author(s) -
Katakam Lakshmi Narasimha Rao,
Ettaboina Santhosh Kumar,
Marisetti Vishnu Murthy
Publication year - 2021
Publication title -
biomedical chromatography
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.4
H-Index - 65
eISSN - 1099-0801
pISSN - 0269-3879
DOI - 10.1002/bmc.5096
Subject(s) - chemistry , chromatography , formic acid , ether , acetonitrile , correlation coefficient , detection limit , organic chemistry , statistics , mathematics
A simple and isocratic reverse‐phase liquid chromatography with mass spectrometric method has been developed and validated for the determination of heptaethylene glycol monomethyl ether in benzonatate drug substance. Benzonatate is an oral antitussive drug used to relieve and suppress cough in patients older than 10 years. The presence of residual heptaethylene glycol monomethyl ether in the benzonatate drug substance affects the safety, strength, purity and quality of the drug substance. The subject compound separation was achieved using 0.1% formic acid and acetonitrile (50:50 v/v) at a flow rate of 0.3 ml/min. The Suplex PKB‐100 250 × 4.6 mm, 5 μm LC column was used for a better peak shape. Detection was carried out at an m / z value of 341. The linearity curve showed a correlation of coefficient of >0.999. The precision and intermediate precision (RSD) were <7.30. The accuracy values were >90% for all levels. The developed method was validated as per International Conference on Harmonization guidelines and found to be a novel, specific and sensitive analytical method for determination of components of interest.