ABSTRACT:
Trace-level elemental impurities in pharmaceuticals pose serious toxicity risks, requiring strict controls to safeguard patients and meet regulatory demands. From January 2018, USP <232> and ICH Q3D supplanted the legacy heavy metals test, specifying sensitive, selective techniques such as ICP-OES and ICP-MS for elemental impurities.1 Elemental impurity controls now form a required element of all regulatory filings. This study developed and validated a sensitive, precise ICP-MS method to quantify elemental impurities in Deflazacort tablets. Microwave digestion with dilute nitric acid prepared samples, extracting tablet matrix impurities effectively while cutting reagent needs and boosting lab safety. The validated method simultaneously quantified key USP <232> elemental impurities for oral products, Class 1(As, Cd, Hg, Pb) and Class 2A(Co, V, Ni) against their PDE limits. Method validation followed USP <233> guidelines, covering specificity, linearity, accuracy, precision, LOD, LOQ, and system suitability. The method successfully analyzed elemental impurities in Deflazacort tablets and oral suspension samples. Validation results confirmed regulatory compliance and backed several market authorization filings. Despite ICP-MS's common use in testing pharmaceutical elemental impurities, no prior validated method targets Deflazacort marketed formulations, as per literature review. The current work fills a key gap with its innovative approach, practical utility and clear research merit.