Escitalopram oxalate is antidepressant of the serotonin reuptake inhibitor (SSRI) class. It is used in for the treatment for the adults with major depressive disorder and generalized anxiety disorder. In the manufacturing process of Escitalopram, 3-Dimethylaminopropyl chloride hydrochloride (3-DMAPC) is one of the process raw materials. Also methane sulfonyl chloride is one of the reagent as well as Isopropyl alcohol is used as a solvent in the process. It is a well known reaction, that methane sulfonyl chloride reacts with alcohols to form respective alkyl methane sulfonate, hence monitoring of Isopropyl methane sulfonate (IPMS) was required in Escitalopram drug substance. The study was proposed for the analysis of 3-Dimethylaminopropyl chloride and Isopropyl methanesulfonate in Escitalopram oxalate drug substance. Method development and validation was conducted with Gas chromatography using Mass spectrometer as detector. Validation of the method was conducted based on International Conference on Harmonization (ICH) guidelines. The LOD and LOQ values were found to be 3 µg/g and 9 µg/g (i.e. 0.15 µg/mL and 0.45 µg/mL) respectively for 3-Dimethylaminopropyl chloride. The LOD and LOQ values were found to be 3 µg/g and 8 µg/g (i.e. 0.15 µg/mL and 0.40 µg/mL) respectively for Isopropyl methanesulfonate. Accuracy results for both the impurities were well within the acceptance criteria of 90 to 100%. Correlation coefficient values for linearity parameter were 0.9992 and 0.9991 for 3-DMAPC and IPMS respectively. Three batches of Escitalopram oxalate were analyzed for the analysis of 3-Dimethylaminopropyl chloride and Isopropyl methanesulfonate. The content for the both the compounds was not detected in all the three batches.
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