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Molecules 2016, 21(11), 1464;

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

Panomics Lambda Therapeutic Research Limited, Gota, Ahmedabad, Gujarat 382481, India
Department of Pharmaceutical Sciences, Gujarat Forensic Sciences University, Gandhinagar 382481, India
Analytical Development and Global Regulatory Affairs, Intas Pharmaceuticals Ltd., Ahmedabad, Gujarat 382213, India
Department of Botany and Microbiology, Addiriyah Chair for Environmental Studies, College of Science, King Saud University, P.O. Box 2455, Riyadh 11451, Saudi Arabia
Department of Medicinal Crop Research, Rural Development Administration, Eumseong, Chungbuk 369-873, Korea
Department of Clinical Pharmacology, College of Medicine, Soonchunhyang University, Cheonan 31151, Korea
Authors to whom correspondence should be addressed.
Academic Editor: Derek J. McPhee
Received: 29 August 2016 / Revised: 25 October 2016 / Accepted: 26 October 2016 / Published: 2 November 2016
Full-Text   |   PDF [205 KB, uploaded 2 November 2016]


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. View Full-Text
Keywords: trastuzumab; LC-MS/MS; dSIL; pharmacokinetics trastuzumab; LC-MS/MS; dSIL; pharmacokinetics
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited (CC BY 4.0).

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Budhraja, R.H.; Shah, M.A.; Suthar, M.; Yadav, A.; Shah, S.P.; Kale, P.; Asvadi, P.; Valan Arasu, M.; Al-Dhabi, N.A.; Park, C.G.; Kim, Y.-O.; Kim, H.J.; Agrawal, Y.K.; Krovidi, R.K. LC-MS/MS Validation Analysis of Trastuzumab Using dSIL Approach for Evaluating Pharmacokinetics. Molecules 2016, 21, 1464.

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