Open AccessGC-FID Technique for the Quantitative Evaluation of Multiple Residual Organic Solvent Impurities in Fosaprepitant Dimeglumine Drug
Author(s) -
H. Ramakrishna Reddy,
S.R. Pratap,
N. Chandrasekhar,
S. Z. Mohamed Shamshuddin
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.2021.23256
Subject(s) - chemistry , flame ionization detector , solvent , dichloromethane , tetrahydrofuran , chromatography , cyclohexane , isopropyl alcohol , acetone , impurity , toluene , gas chromatography , ethyl acetate , methanol , hexane , analytical chemistry (journal) , organic chemistry
A proficient and distinct methodology is established for the quantification of multiple residual organicsolvent impurities in fosaprepitant dimeglumine drug substance by gas chromatography with headspacesampler (HS-GC) and flame ionization detector (FID). Chromatographic separation was executed ona fused silica dimethylpolysiloxane capillary column (HP-1; USP G2 phase having dimensions, 60 mlength × 0.53 mm dia & 5 μm film thickness). The validation of optimized method was carried out inaccordance with relevant validation principles. The authenticated procedure was noticed to be specific,precise, linear, accurate, robust and rugged with concentration ranging from lowest quantification level(LQL) to 200% specification level for each residual organic solvent impurities (methanol, ethanol, acetone,isopropyl alcohol, dichloromethane, methyl tert-butyl ether, ethyl acetate, tetrahydrofuran, cyclohexaneand toluene). The established technique was productively useful to determine the residual solventimpurities in fosaprepitant dimeglumine.