Determining Extractable Phthalates in Pharmaceutical Products Using Lcms/Ms

Abstract

This study examines the determination of extractable phthalates from pharmaceutical products employing a highly sensitive and selective analytical technique, that is, LC-MS/MS. Widely used plasticizers in both pharmaceutical packaging and drug formulations, phthalates have been seriously associated with concerns for health based on their toxicological and possible endocrine-disrupting activities, including those concerning reproductive toxicity and hormonal disturbances. Despite rigorous regulatory limits from the U.S. Continuing with detection of phthalates in pharmaceuticals by FDA and EMA is intentional addition in excipients, and sometimes even from the packing material. In this research study, a suitable LC-MS/MS method for identification and quantification of phthalates in some chosen pharmaceutical formulations, its regulatory limits compliance, and its risks towards the consumer health have been devised and validated. Among the 15 pharmaceutical samples evaluated, it showed a variable amount of phthalates and sometimes higher than the permissible limits. The results reiterate the implementation of strict monitoring as well as regulatory compliance in order to minimize the exposure of phthalates and ensure drug safety.