Simultaneous Estimation of Fenofibric Acid Tablets' Elemental Impurities using Inductively Coupled Plasma Mass Spectrometry (ICP-MS)

Control of elemental impurities in medications and pharmaceuticals, as outlined in USP <232> and ICH Q3D, is a mandatory prerequisite for regulatory approval. This study introduces a microwave-assisted sample preparation method for Fenofibric Acid Tablets using diluted nitric acid. Through addition and recovery experiments conforming to oral permissible daily exposure values for Class 1 (As, Cd, Hg, and Pb) and Class 2A (Co, V, and Ni) elements, each sample was spiked with element concentrations of 2.5J and 1.5J to assess recoveries in accordance with USP <233> requirements. Our findings demonstrate the efficacy of a matrix that addresses low spike recovery issues, enabling the simultaneous determination of Class 1 and Class 2A elements in a single analysis. The analytical procedure undergoes validation for Specificity, Limit of Detection, Limit of Quantitation, Linearity, Precision (System Precision and Method Precision), Intermediate Precision, Accuracy, and System Suitability. This validated analytical method is suitable for detecting elemental impurities in Fenofibric Acid Tablets, supporting their regulatory submission in various regulated markets.