Page 31 - Shimadzu Journal vol.9 Issue2

Shimadzu Selection

Determination of Protein Secondary Structures of Selective and Sensitive Method for Estimation of
Monoclonal Antibody using FTIR Spectroscopy Liraglutide in Human Plasma using LCMS-8060
Monoclonal antibodies (mAbs) are a major class of biopharmaceuticals Liraglutide is a glucagon-like peptide-1 receptor agonist (GLP-1 receptor
due to its wide application in medicine and biological science. The anti- agonist) also known as incretin mimetics. Liraglutide was analyzed in
body’s biological activity can be attributed to its unique structural confor- human plasma using a solid phase extraction method in MRM mode on
mation. Protein higher order structure (HOS) includes the secondary, LCMS-8060. The developed method is selective and sensitive for estima-
tertiary and quaternary structures of protein, which comprise the three tion of liraglutide in human plasma. In this article, Liraglutide was analyzed
dimensional structures of protein. Analysis of the HOS of mAbs is essen- in human plasma using a solid phase extraction method in MRM mode on
tial to ensure the quality and efficacy of the protein therapeutics product. LCMS-8060. The developed method is selective and sensitive for estima-
In this application news, the secondary structure of mAbs is examined by tion of liraglutide in human plasma.
using FTIR spectroscopy and band curve-fitting data analysis.

Simultaneous estimation of Insulin glargine and Experimental Studies of a Novel Multi-turn
it’s excipients in formulation using LC-UV-MS/MS Time-of-Flight Mass Spectrometer and
Simultaneous estimation plays a very important role in biopharmaceutical Its Applications for High Mass Molecules
industry as it is very feasible and time saving. For the multi component The needs for high resolving power and sensitivity analyses of high mass
analysis various techniques like spectrophotometric techniques (UV-VIS, molecules has been increasing in many fields such as biopharmaceutical
IR, NMR and mass spectrometry) and chromatographic techniques (Thin and material industries. Time-of-Flight mass spectrometer (TOF MS) is a
Layer Chromatography, High Performance Liquid Chromatography, suitable solution to meet these needs. A novel Multi-turn Time-of-Flight
Ultra-High Performance Liquid Chromatography, High Pressure Thin Layer mass spectrometer has been developed for biopharma and life science.
Chromatography and Gas Chromatography) is used. In this poster, an High mass resolving power of over 150k has been demonstrated for bio-
LC-UV-MS/MS method has been developed for the simultaneous molecules including reduced monoclonal antibody. Here, we show the
determination of insulin glargine and its excipients in formulation. details of the instrument and the results of the performance evaluations
for high mass biomolecules.

Quantitation of Nitrosamines in Metformin Active Got DMF? Chromatographic separation and
Pharmaceutical Ingredient (API) using static and identification of NDMA and DMF using LCMS-9030
dynamic headspace GCMS/MS Chromatographic separation and identification of dimethylformamide
Health Sciences Authority (HSA) of Singapore on 4th December 2019[1], (DMF) and N-nitroso-dimethylamine (NDMA) was performed to prevent
recalled 3 out of 46 locally marketed Metformin medicines after detecting overestimation of NDMA when DMF interference is present. This method
presence of NDMA “above the internationally acceptable level” and this can easily be implemented for the impurity evaluation of active pharma-
subject came into mainstream. Subsequently, both the US Food and Drug ceutical ingredients (API), intermediates, and final drug products irrespec-
Administration (FDA) and the European Medicines Agency (EMA) have tive of triple quadrupole or high-resolution mass spectrometers.
released regular updates into their investigations for the causes of medi-
cine contamination. Metformin is the first-line drug control of high blood
sugar levels in patients with type 2 diabetes, particularly in people who
are overweight.

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