Development and Validation of an ICP‐OES Method to Determine Extractable and Leachable Metals in HDPE (Plastic) Pharmaceutical Packaging Material

ABSTRACT The safety and effectiveness of pharmaceutical medicines depend heavily on extractables and leachables. Patients may be adversely affected by contaminants that enter drug products through packing materials. As a result, regulatory organizations like the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have set standards and regulations for evaluating and managing extractables and leachables. Characterizing the packing materials, carrying out extraction experiments and checking the extracted solutions for contaminants are all parts of this research. As part of the process for approving new drugs, regulatory agencies make use of these data. In present work, an inductively coupled plasma optical emission spectroscopy (ICP‐OES) method is developed and validated for quantifying trace elements from a high‐density polyethylene (HDPE) packaging material. The approach delineated in accordance with United States Pharmacopoeia (USP) and for the comprehensive analysis of 16 metallic elements including aluminium, arsenic, cadmium, chromium, cobalt, lead, mercury, nickel, titanium, vanadium, zinc, zirconium, barium, manganese, calcium and tin is applicable for evaluating the efficacy of packaging materials. The method detection limits (MDLs) complied as per USP 39‐NF 34 along with relative standard deviations (RSDs) obtained were ranging from 0.3% to 3.1% and recoveries of all elements spiked at two different trace levels in HDPE samples were within 97%–110%, providing sensitive, accurate and reproducible methodology.