New frontiers for HRMS in regulated environment
Tuesday 27th September 2016
07:00 [PDT] 10:00 [EDT] 15:00 [BST]
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Mass spectrometers are continuously increasing in the selectivity, sensitivity and overall quality of data generated. Specifically, High Resolution Mass Spectrometers (HRMS) are able to provide major advantages in quantitative analysis by offering a unique combination of sensitivity and selectivity . Previously associated with metabolite identification and other qualitative purposes, HRMS are now reaching the sensitivity and linearity offered by common triple quadrupole instruments, which are still considered as the gold standard for quantitative analyses.
Hence, HRMS are starting to be considered as potential alternative to regular triple quadrupole for quantitave analysis. Nonetheless, these instruments still have the reputation of being less sensitive and robust than the triple quadrupole . HRMS technology is commonly used in Angelini for qualitative or Qual/Quant analysis such as metabolic studies, characterization of new chemical entities and of impurity profile of API. Recent publications [Morin, Mess and Garofolo – Bioanalysis, Bioanalysis (2013) 5(10)] demonstrated the possibility to use HRMS for quantitative bioanalytical studies.
However, HRMS has been rarely employed for the quantification of genotoxic impurities of API. USP trazodone hydrochloride monograph includes a test with a Limit of Trazodone Related Compound F (TRC-F) and Cyclophosphamide Related Compound A (CRC-A), in the manufacturing process, less than 2.5 ppm each using LC-MS/MS. In this work, HRMS was used in regulated environment for the determination of TRC-F and CRC-A and its performance was compared with LC-MS/MS procedure reported in the USP monograph.
The validation results showed that the HRMS method was comparable to the USP LC-MS/MS method in terms of linearity, sensitivity, accuracy and precision. Moreover, the use of HRMS increased the selectivity of the analytical procedure, while the use UPLC allowed to significantly reduce the run time and mobile phase consumption. In conclusion, it was successfully demonstrated that the HRMS technology can be utilized for quantification of small molecules in API in a regulated environment.
Reference:
Garofolo F. HRMS Rising. AAPS Blog, https://aapsblog.aaps.org/tag/fabio-garofolo (2015).
What will you learn?
- Major advantages of HRMS in quantitative analysis
- HRMS unique combination of sensitivity and selectivity (S&S)
- Overcoming S&S challenges by HRMS
- HRMS as potential alternative to triple quadrupole for quantitative analysis.
Who may this interest?
- Pharmaceutical Companies
- CRO
- Analytical & Bionalytical scientists
Speaker
Fabio Garofolo
Head of Research
Angelini Pharma
Dr. Fabio Garofolo has been working in the pharmaceutical and analytical fields since 1989. Capitalizing on an extensive occupational background within his specialization field, he has also been involved to help scientific non-profit organizations (AAPS, ASMS, CFABS, CVG, GBC, GCC and NBC) with the mission to promote discussion on the pharmaceutical practices. Dr. Garofolo has progressed throughout in his career in both the pharma/biotech R&D and CRO industries and he is presently the Head of Research at Angelini Pharma. He has over 180 publications & presentations in international conferences. Dr. Garofolo developed over 400 innovative methods. He designed and invented 3 innovative bioanalytical approaches and is the recipient of the following Lilly awards: Achievement (2001); Global (2002); Emmerson (2003). His current interests include analysis of Large Molecules by Hybrid LBA/LCMS, HRMS, DBS, and LBA Emerging Technologies.
For more from our Spotlight on Quantitative HRMS please see here and for a full list of other webinars available on Bioanalysis Zone please see here.