Der Pharma Chemica
Journal for Medicinal Chemistry, Pharmaceutical Chemistry, Pharmaceutical Sciences and Computational Chemistry
ISSN: 0975-413X
Abstract
Determination and validation of Monomethylamine content by Ion Chromatography method in pharmaceutical drug substances
Author(s): K. S. R. Pavan Kumar, Vundavilli Jagadeesh Kumar, S. John Prasanna, M. Narendra Kumar, K.V. S. N. Raju, Pradeep Rajput, Hemant Kumar Sharma and K. MukkantiA simple and sensitive ion chromatography method was developed, optimized and validated for the determination of Monomethylamine (MMA) in various drug substances, which is the process impurity. The validation of analytic method was realized through specificity, linearity, LOD, LOQ, precision and accuracy parameters. A model compound, Tadalafil drug substance was chosen for this study and limit of detection (LOD) and limit of quantification (LOQ) values were 0.09 μg/mL and 0.30 μg/mL respectively. The average accuracy value is 101.6%. And also determination of MMA in different drug substances like Alfuzosin hydrochloride, Sumatriptan succinate, Sertraline hydrochloride and Didanosine with slight modifications in methodology were discussed in this work
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Citations : 25868
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