Metabolite Detection and Profiling Using Analytical Methods

Abstract

To develop effective and safe drugs and to take them to market in short period of time is the mission of pharmaceutical research companies. A selection of few of the lead compounds are done for the evaluation of safety and their ADMET (absorption, distribution, metabolism, excretion and toxicology) properties are tested in in-vitro (test systems), in-vivo (living organisms) and in-silico (computational methods). From initial stages to final stages of modern drug discovery process, the vital tool for detecting & characterizing metabolites is MS (Mass spectrometry) hyphenated with other techniques. The methods used for generation of metabolites are in-vitro techniques and cell lines (containing expressing drug metabolizing enzymes and heterologous genes). The use of HPLC-MS/UPLC-MS and high resolution MS, enables the in depth metabolite detection and profiling studies and it may also be likely to identify and characterize the site and types of biotransformation.

Development and Validation of Liquid Chromatography-Tandem Mass Spectrometric Method for the Quantification of Diclofenac in Human Plasma

“…The benefits of the current method include a rapid and simple extraction operation employing only one solvent, a short run-time, low noise and good sensitivity and selectivity. Various LC-MS/MS methods are available [11][12][13][14][15][16] .…”

Development and Validation of Novel and Highly Sensitive Stability-Indicating Reverse Phase UPLC Method for Quantification of Dabrafenib and its ten Degradation Products

“…[16][17][18][19][20][21][22][23][24][25][26] Separation, identification and characterization of degradation products of few anticancer drugs using the UPLC-MSMS technique have been reported. [27][28][29][30] HPLC is now an outdated technology in terms of sensitivity and cost-effectiveness. Till date, no study is reported on the degradation and stability of drugs under varied conditions such as hydrolytic, oxidative, thermal and photolytic.…”

Development and Validation of a Stability-indicating Method for Neostigmine Bromide: Separation, Identification and Characterization of Degradation Product using LC-MS and ESI-Q-TOF-MS/MS

“…[10][11][12][13][14][15][16][17][18][19][20][21][22][23][24] Separation, identification and characterization of DPs of few anticancer drugs using the UPLC-MSMS technique have been reported. [25][26][27][28][29][30][31][32][33][34] Based on the recommendations of ICH guidelines Q3A (R2) and Q3B (R2), identification and characterization of all the DPs or process-related impurities of dabrafenib have been carried out. [35][36] But to date, no study is reported on the degradation and stability of drugs under varied conditions such as hydrolytic, oxidative, thermal and photolytic.…”