What do you need to know about the Bioequivalence Study for Drug Development?

If you take a dig at the last two decades of the drug discovery and development evolution, the contribution of MS (Mass Spectrometry) as an analytical tool has been highly appreciating. Today, with its sophisticated technology, the brilliance of Mass Spectrometry (MS) is widely employed throughout the drug development process.

MS, when coupled with HPLC testing to function as LC-MS (Liquid Chromatography-Mass Spectrometry), efficiently aids in orthogonal detection function. It imparts unique capabilities to the pharmaceutical analysis for analyzing the crucial parameters of selectivity, sensitivity, rich mass information and speed of analysis.

Significance of LC-MS assays –

When Mass Spectrometry is used in conjunction with the High-Performance Liquid Chromatography, LC-MS functions as both an indispensable and a powerful analytical tool with a wide array of applications. This technique of LC-MS provides a higher level of specificity and sensitivity. Besides, these two parameters, the simultaneous analysis of multiple analytes is a plus point to the researchers worldwide.

Liquid Chromatographic parts of the LC-MS unit helps in the separation of organic compounds from small drug metabolites such as proteins and peptides. Furthermore, the mass spectral analysis adds-on to the specificity needed for both qualitative and quantitative analysis of the drug under analysis. A more sophisticated version of the LC-MS is the LC-MS-MS analysis where a single mass spectrometer performs multiple analysis on a single sample. This includes simultaneous generation of a mass spectrum, ion fragmentation, generating other mass spectra and repeating the examination as many time as the researcher wants.

Potent benefits of integrating the LC-MS (Liquid Chromatography-Mass Spectrometry) assay into drug development –

LCMS based techniques, mainly the lc ms ms analysis test, provide different parameters for pharmaceutical drug evaluation.

Such analysis are essential from pharmaceutically important compounds as they feature a wide array of analytical figures of merit (selectivity, sensitivity, cost-effectiveness, and speed of study).

With the advancement in technology, the market has witnessed tremendous growth in LCMS applications and productivity.

The parameters produced by the mass spectra of LC-MS-MS test functions as essential analytical features in the entire process of drug discovery and development.

LCMS methodologies such as surrogate or predictive models, automation, and open access systems are functioning as permanent fixtures throughout the process of drug development.

Where is the Liquid Chromatography-Mass Spectrometry actually being employed in drug discovery and development phase?

Here are some of the standard applications of the LCMS instrument –

• In the stage of drug discovery and development, the lead candidate should undergo an initial analysis both for metabolic stability profiling and natural protein identification. This is done by using LCMS analysis.

• Determination of the molecular weight of the compounds of interest are crucial parameters for combinational or medicinal chemistry. This is done in support of LCMS instrument.

• Glycoprotein mapping for glycoprotein identification and protein mapping for protein identification are both done by using LCMS.

• LCMS plays a crucial role in the bio affinity screening analysis and the natural product dereplication process.

• Metabolic stability analysis and pharmacokinetic screening are crucial stages in the lead trial optimization process. Both these analyses are worked out with the assistance of LCMS screening.

Thus, one can say that the importance of Liquid Chromatography-Mass Spectrometry right from the raw material selection to the drug discovery and development can’t be simply ignored. In fact, its application is proving a boon in many aspects of drug discovery and development process such as – identification of lead molecule and impurities; studying metabolic and pharmacokinetic drug profiles; degradant identification and impurity profiling.

Maria Brown is a medical expert who blog on patient safety and drug efficacy. She’s working for a top medical equipment company. Maria Brown has granted a large online following for herself as an expert medical thought leader.