Abstract

A simple and efficient Gas Chromatography (GC) analysis method was developed to identify and quantify plasticizers commonly used with polymers present in delayed release tablets. The plasticizers investigated included Dibutyl Sebacate (DBS), Tributyl Phosphate (TBP) and Tributyl Acetyl Citrate (TBAC). The Gas Chromatography (GC) analysis method employs a common DB-1 GC column (30mx320µm; 3.0µm film). The method was shown to be specific and linear (r²=0.998-1.000). Both accuracy and precision were established across the analytical range (0.8-2.0mg/mL). Method applicability was demonstrated by analyzing currently marketed DR tablets from different manufacturers.

Keywords

gas chromatography, plasticizers, dibutyl sebacate, tributyl phosphate, tributyl acetyl citrate, delayed release tablets, high-performance liquid chromatography, tributyl phosphate, polymeric films, drug release, polymers, physico-chemical properties, validation, standard calibration, coating films, data processing