Abstract

Effect of time, temperature and UV radiation on migration of plasticizers and anti-oxidant from pack component to product analyzed by gas chromatography

Author(s): Mihirkumar G.Patel, Pravin O.Patil, Sanjay B.Bari

Plastic is one of the materials that are widely used for the packaging of pharmaceutical products. In this study, the effect of time, temperature and UV radiation on migration of Plasticizers [di (2-ethylhexyl) phthalate (DEHP), di (2-ethylhexyl) adipate (DEHA)] and Antioxidant [3, 5-di-tert -butyl-4-hydroxy-toluene (BHT)] from PET, HDPE and laminated tube containers to the pharmaceutical formulations was investigated. Selected marketed pharmaceutical formulations were stored at 30°C, 40°C for six months, 50°C for one month and analyzed periodically by gas chromatography. It was concluded that the storage temperature had a large effect on the migration of Plasticizers and Antioxidant as compare to storage time and UV radiation. The PET, HDPE and laminated tube containers saws migration of BHT and DEHA but no single trace of DEHP was observed. HDPE container saw more migration as compare to PET and LAMI TUBE containers. The concentrations of migrating substances did not exceed its specific migration limit.