2015
DOI: 10.15680/ijirset.2015.0403005
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Development and Validation of LC-MS/MS Method for the Analysis of P-Toluenesulfonicacid, In Antiviral Drug Acyclovir

Abstract: A sensitive and selective liquid chromatographic-tandem mass spectrometric (LC/MS/MS) method was developed and validated for the trace analysis (>1 ppm level) of p-Toluenesulfonicacid, a genotoxic impurity, in acyclovir drug substances. The chromatographic separation was achieved on Symmetry C-18 (150 X 4.6mm, 3.5µm) column using a mobile phase consisting of 5 mM ammonium acetate and methanol (70:30 v/v) at flow rate of 0.4 mL /min. The API-4000 LC/MS/MS was operated on an electrospray in negative mode. The se… Show more

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