活性药物中主要成分定量分析检测方案(等离子体质谱)

Using heteroatoms as elementallabels in the quantitative analysis ofactive pharmaceutical ingredients by HPLC-ICP-QQQ Introduction： LC-MS/MS is widely used in every stage of drug development， from discovery and characterizationthrough manufacturing and quality control of the final pharmaceutical product. Due to its excellentselectivity for complex molecules， LC-MS/MS is an effective tool for both non-target qualitativeanalysis and quantitative analysis of targeted compounds.However， the sensitivity of LC-MS/MSvaries significantly depending on the molecular structure of each compound， and can be affected byother coexisting substances in the sample. This limitation means that LC-MS/MS is often unable toprovide：accuratequantitative analysis without acompound-specific calibration1standard.Inductively Coupled Plasma Mass Spectrometry (ICP-MS) is a fast multi-element technique capableof accurate elemental quantification at trace and ultra-trace levels. While more widely adopted ininorganic，“metals”laboratories， ICP-MS is also used in the field of pharmaceutical analysis when aheteroatom-containing drug is the focus of interest [1， 2]. ICP-MS employs a high temperatureplasma ion source that decomposes the sample to the atomic level. The high temperature Agilent Technologies 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 . ICP-MS employs a high temperature plasma ion source that decomposes the sample to the atomic level. The high temperature