Organic volatile contaminants and Residual impurities present in pharmaceutical products are estimated by using Head Space Gas Chromatography. In this study a Head Space Gas Chromatography method was used to detect residual solvents and organic volatile contaminants present in Acyclovir Dosage form. Acyclovir is an antiviral drug used to treat viral infections. In this study an attempt was made to analyze the residual organic solvents such as Methanol and Acetone present in Acyclovir Dosage form by headspace gas chromatography (HS-GC). The carrier gas streamed was nitrogen, the method was developed and optimized by using DB-624 (30 m × 0.25 mm × 1.4 µm) column coupled with flame ionization detector. Capillary column consisting of 6 % cyanopropylphenyl - 94 % dimethyl polysiloxane was employed as stationary phase. An injector temperature of 300°C was programmed to prevent degradation. A temperature of 40°C was set as the initial oven temperature for a period of 4 min and set at a rate of 30°C min−1 and monitored at a final temperature of 200°C for 6 min. N,N-dimethylacetamide was selected as the sample solvent. The validation studies were performed with regard to International Council for Harmonisation (ICH) Q2 guidelines for validation of analytical experiments. All the validation parameters complied with the specification limit. Hence, the optimized method developed and validated can be utilized for the concurrent detection of residual solvents in tablet formulations.

Keywords: Acyclovir Tablets; Acetone; GC-HS; Methanol; Organic Volatile Impurities; Residual Solvents;