Tag: Pharmaceutical Analysis

In the constantly changing analytical chemistry and research field, there is a demand for more precise and reliable analytical methods. Liquid chromatography-mass spectrometry (LC-MS) has proven to be a vital methodology that has transformed life science and related fields. LC-MS analysis plays a pivotal role in pharmaceutical development and formulation. In this blog, we delve into the advancements in LC-MS Technology and how they have revolutionized the pharmaceutical field.

Understanding LC-MS and Its Principle

LC-MS technology involves an HPLC where individual components of a mixture are first separated, which is followed by ionization and separation of ions on the basis of their mass/charge ratio. The separated ions are later directed to a photo or electric multiple-tube detector that identifies and quantifies every ion. The ion source is a vital component in MS analysis as it helps precisely generate ions for analysis. The ion source can be Electrospray Ionization (ESI) or Atmospheric Pressure Chemical Ionization (APCI) for ionizing intact molecules. LCMS analysis together provides a robust solution for analyzing complex mixtures in pharmaceutical products.

Application of LC-MS in Pharmaceutical Analysis

LC-MS Technology is a comprehensive tool for various challenges faced in pharmaceutical research and development. It offers a reliable, versatile, and robust platform for gaining critical data at every stage of drug development.

LC-MS Application Across Drug Development Stages in Pharmaceutical

Stage 1: Discovery of the drug candidate 

• Quick LC-MS for monitoring target drug candidate
• High-resolution MS analysis for structural proof.
• Vitro pharmacokinetic & metabolic research 

Stage 2: Chemical drug development & scale-up

• Structural confirmation of initial material, intermediaries, and final target drug candidate. 
• Evaluating impurity profiles in every batch
• Characterisation and qualification of drug substances

Stage 3: Stability Testing 

• Monitoring variation in impurity profiles. 
• Analyzing compatibility within drug compounds, formulation excipients, and packaging material. 
• Analyzing intrinsic stability and degradation pathways
• Examination of chromatographic peak purity 
• Developing  impurity profiles under a stressed condition

Stage 4: Drug Metabolites, Pharmacokinetic and Toxicological Studies

• Identifying drug metabolites under physiological conditions
• Quantitation of drug substances and metabolites in biological mixture
• Monitoring impurity profiles 
• Ongoing examination of impurity profiles on drug products and substances under long storage conditions.

Recent Advancement in LC-MS

Hardware Enhancements: 

• Improved ionization methods
• Enhanced system efficiency
• More sensitive detectors

New Ionization Techniques: 

• Electrospray Ionization Inlet (ESII): This is a sophisticated technique that applies high voltage to a metal union, which connects tubing from a solvent delivery system to a piece of fused silica tubing that is put into the heated inlet tube of a mass spectrometer. 
• Uni-spray: It takes advantage of the vortex and Coanda effect to form droplet break-up and dissolvation.

Improved Sensitivity and Resolution 

Another remarkable advancement in LC-MS Technology is the enhancement in resolution and sensitivity. The more advanced models are more versatile and detect even traces of compounds, which is valuable in identifying unknown impurities. 

Software Enhancement 

Aral Research is a renowned LCMS analysis service lab equipped with the latest LC-MS systems, which feature real-time analysis, cloud storage, and automation. The advanced algorithms are ideal for complex samples and offer easy integration and precise results. 

Conclusion

The LC-MS technology constantly evolves to cater to the diverse development and research requirements. Not just the pharmaceutical, but LC-MS plays a pivotal role in the life science field. Aral Research is a leading liquid chromatography-mass spectrometry lab in India that has hands-on experience with approved and novel drugs. With high sensitivity, high qualitative capability, and high detection selectively, our LCMS services focus on the flexibility of simultaneous multi-component analysis. We can help solve complex analytical questions with forefront analytical techniques.