Analytical method validation for the determination of Acetic acid content in Decitabine API by Gas Chromatography

Abstract

The analysis of residual organic solvent acetic acid in Decitabine, an active pharmaceutical ingredient was investigated. Decitabine is nucleic acid synthesis inhibitor beta blocker used for the treatment of myelodysplastic syndromes, a class of conditions where certain blood cells are dysfunctional, and for acute myeloid leukemia (AML). The Auto sampler gas chromatography method described in this investigation utilized ZB-WAX Plus, 30 meter x 0.53 mm with 1 μm film thickness, Flow rate at 3.0 mL/minute, FID detector.. The injector temperature was set at 240ºC. Nitrogen was used as a carrier gas. The method was validated to be specific, linear, precise, sensitive, rugged and showed excellent recovery.