NDLI: LC-MS/MS Validation Analysis of Trastuzumab Using dSIL Approach for Evaluating Pharmacokinetics

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LC-MS/MS Validation Analysis of Trastuzumab Using dSIL Approach for Evaluating Pharmacokinetics

Content Provider	MDPI
Author	Budhraja, Rohit Shah, Milin Suthar, Mahendra Yadav, Arun Shah, Sahil Kale, Prashant Asvadi, Parisa Valan Arasu, Mariadhas Al-Dhabi, Naif Park, Chun Kim, Young-Ock Kim, Hak Agrawal, Y. Krovidi, Ravi.
Abstract	Quantitative targeted proteomics based approaches deploy state-of-the-art Liquid chromatography tandem mass spectrometry LC-MS technologies and are evolving as a complementary technique to standard ligand-binding based assays. Advancements in MS technology, which have augmented the specificity, selectivity and sensitivity limits of detection and freedom from antibody generation, have made it amicable towards various clinical applications. In our current work, a surrogate peptide based quantitative proteomics assessment is performed by selecting specific signature peptides from the complementary determining region CDR region of trastuzumab (Herclon®, Roche products in India). We developed a double Stable Isotope Label (dSIL) approach by using two different surrogate peptides to evaluate the proteolytic digestion efficiency and accurate quantification of the target analyte peptide of Herclon® in human serum. Method validation experiments were meticulously performed as per bioanalytical method validation guidelines. The dSIL approach, using an LC-MS/MS based quantification assay demonstrated good linearity over a range of 5–500 µg/mL of Herclon®, and validation experimental data is in compliance with bioanalytical regulatory guidelines.
File Size	209920
File Format	PDF
e-ISSN	14203049
DOI	10.3390/molecules21111464
Journal	Molecules
Issue Number	11
Volume Number	21
Language	English
Publisher Date	2016-11-02
Access Restriction	Open
Subject Keyword	trastuzumab LC-MS/MS dSIL pharmacokinetics
Content Type	Text
Resource Type	Article

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