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QUANTITATIVE DETERMINATION OF METHYL-4-CHLOROBUTYRATE IN NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS BY GCMS USING ELECTRON IONIZATION
Perla Ganesh*, Ch. B. V. Narasimha Raju, Suman Gundlapalli, Dharamasoth Rama Devi, K. Basavaiah*
ABSTRACT
The objective of the present study was to develop and validate a trace level of Methyl-4-chlorobutyrate (MCB) impurity in Nucleoside Reverse Transcriptase Inhibitor (NRTI) drugs by using Gas Chromatography with Mass Spectroscopic method. A capillary Gas Chromatography (GC) column was used with a stationary phase 100% Dimethyl polysiloxane and the mode opted for Selective Ion Monitoring (SIM) comprised of an Electron Impact (EI) source. Methanol was used as a diluent and a dissolve-and-injection approach was adopted for sample introduction in a split mode. The calibration curves showed good linearity over the concentration range (Limit Of Quantitation (LOQ) to 150%) of 1.0 to 3.75 ppm. The correlation coefficient obtained was >0.99. The Limit Of Detection (LOD) Keywords: Low level determination, Gas chromatography-mass spectrometry, Nucleoside Reverse Transcriptase Inhibitor drug, Methyl-4-chlorobutyrate impurity. [Download Article] [Download Certifiate] |