The mass spectrometry analysis is a powerful analytical method utilized in bioanalysis for obtaining quantitative and qualitative data related to analytes. The method is widely used in the pharmaceutical industry to understand molecular and atomic processes along with assessing the relevance of events in the cells. The mass spectrometry analysis especially assists in controlling biological and chemical processes of bioanalytics, which are useful in drug discovery and development. This article will discuss the principles and uses of mass spectrometry in drug development.
Understanding Mass Spectrometry
The analysis quantifies the unknown compounds in a given drug product, sample, or candidate. The process converts the sample into gaseous ions without or with fragmentation to characterize these ions by mass-to-charge ratio.
Firstly, the process forms gaseous ions from the given sample using one of the ionization techniques, usually electron ionization. These ions are then fragmented and passed through a mass spectrometer where the ions are separated based on the mass-to-charge ratio. The separated ions are detected for their separate relative abundance – using which mass spectrum is generated.
Components of Mass Spectrometry
There are various types of mass spectrometry analysis such as Liquid Chromatography MS, Ion Mobility Spectrometry MS, Gas Chromatography MS, etc. However, the working and functioning consist of three common components.
The ionizer is the source of making gaseous ions from the sample product that is being tested. The sample which is being assessed is heated to vaporise the molecules, which are then bombarded with an electron beam. Due to this electron beam contact, ions are formed from vapours. Since mass spectrometry analysis quantifies only the charged ions, electrons are either given or taken from the ions.
Note: It is necessary to note that a sample would be assessed through mass spectrometry only when vaporisation is possible without decomposition.
The analyzer contains two phases, acceleration, and deflection. In acceleration, the positive ions accelerate in the direction of the negative plates. The speed of acceleration is based on the mass
of the ion. This means that heavier molecules will move slower in comparison to lighter molecules. In deflection, the magnetic field deflects the ions based on their mass.
The separated ions reach the detector consecutively, which is formed into a computerized spectrum for analysis.
Mass Spectrometry in Drug Development
During drug discovery and development, assessing the component present in a drug candidate along with their characteristics is essential to know the healing impact of the drug. This field of bioanalysis offers the right biomarker required for finding a healing drug relevant to a particular disease or illness.
Owing to the high selectivity and sensitivity offered by the analysis, this method is utilized in various phases of drug development. From drug discovery to clinical trials, mass spectrometry assesses the toxicity and efficacy of a drug compound. The technique also evaluates, in various stages, if the drug compound can cause health issues in animal suspects or human volunteers.
Once the drug is approved by FDA and it reaches the market, the analysis evaluates the efficiency of correct execution of the manufacturing process. It ensures that the processes and packaging utilized for the manufacturing don’t change drug components.
The mass spectrometry analysis assists in bioanalysis by quantifying the analytes or components of a sample product. Knowing the presence, impact, and characteristics of the components help in the successful completion of the drug manufacturing process. The technique ensures the efficacy of the drug compounds throughout the drug development process.