Using heteroatoms as elemental labels in the quantitative analysis of active pharmaceutical ingredients by HPLC‐ICP‐QQQ

LC-MS/MS is widely used in every stage of drug development, from discovery and characterization through manufacturing and quality control of the final pharmaceutical product. Due to its excellent selectivity for complex molecules, LC-MS/MS is an effective tool for both non-target qualitative analysis and quantitative analysis of targeted compounds. However, the sensitivity of LC-MS/MS varies significantly depending on the molecular structure of each compound, and can be affected by other coexisting substances in the sample. This limitation means that LC-MS/MS is often unable to provide accurate quantitative analysis without a compound-specific calibration standard. Inductively Coupled Plasma Mass Spectrometry (ICP-MS) is a fast multi-element technique capable of accurate elemental quantification at trace and ultra-trace levels. While more widely adopted in inorganic, “metals” laboratories, ICP-MS is also used in the field of pharmaceutical analysis when a heteroatom-containing drug is the focus of interest [1, 2]. ICP-MS employs a high temperature plasma ion source that decomposes the sample to the atomic level. The high temperature Using heteroatoms as elemental labels in the quantitative analysis of active pharmaceutical ingredients by HPLC‐ICP‐QQQ