Analysis of Residual Solvents in Co-amoxiclav Coated Tablets Using Solid Phase Microextraction–Gas Chromatography

Abstract

Co-Amoxiclav tablets are coated tablets. The tablet coating process requires an organic solvent in the sealing stage. Several processes are carried out to remove organic solvents in the finished drug product, such as heating and pressure reduction, which still leaves organic solvents in the finished drug preparation. The purpose of this study was to optimize the solid phase micro- extractionmethod–gas chromatography for the analysis oforganic solvent residues in co-amoxiclav tablets and the determination of the residual solvent content. The extraction method used was the headspace-SPME method, sample extraction by heating so that the solvent residue evaporated and absorbed by the PDMS-DVB (Polydimethylsiloxane-divinylbenzene) fiber. The extraction process was carried out by optimizing the temperature and time. The gas chromatography system used was the detector temperature of 250 °C, and the injected port temperature was 210 °C. The oven temperaturewas programmed, ranging from 38 °C to 210 °C with a temperature increase of 10 °C/min with a holding time of five minutes. The helium carrier gas flow rate was 0.71 mL/min. Analysis of residual solvent was conducted by looking at the retention time and peak area then comparing them with the standard solution. The optimal temperature and time of the extraction using SPME were 50 °C and 30 min. The residue analysis results showed that the co-amoxiclav coated tablets contained 2.88±0.58 ppm dichloromethane residues.