Next Article in Journal
Cytotoxic, Antitumor and Immunomodulatory Effects of the Water-Soluble Polysaccharides from Lotus (Nelumbo nucifera Gaertn.) Seeds
Previous Article in Journal
Current Advances of Tubulin Inhibitors in Nanoparticle Drug Delivery and Vascular Disruption/Angiogenesis
Article Menu
Issue 11 (November) cover image

Export Article

Open AccessArticle
Molecules 2016, 21(11), 1464; doi:10.3390/molecules21111464

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

1
Panomics Lambda Therapeutic Research Limited, Gota, Ahmedabad, Gujarat 382481, India
2
Department of Pharmaceutical Sciences, Gujarat Forensic Sciences University, Gandhinagar 382481, India
3
Analytical Development and Global Regulatory Affairs, Intas Pharmaceuticals Ltd., Ahmedabad, Gujarat 382213, India
4
Department of Botany and Microbiology, Addiriyah Chair for Environmental Studies, College of Science, King Saud University, P.O. Box 2455, Riyadh 11451, Saudi Arabia
5
Department of Medicinal Crop Research, Rural Development Administration, Eumseong, Chungbuk 369-873, Korea
6
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
View Full-Text   |   Download PDF [205 KB, uploaded 2 November 2016]

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. 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).

Supplementary material

Scifeed alert for new publications

Never miss any articles matching your research from any publisher
  • Get alerts for new papers matching your research
  • Find out the new papers from selected authors
  • Updated daily for 49'000+ journals and 6000+ publishers
  • Define your Scifeed now

SciFeed Share & Cite This Article

MDPI and ACS Style

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.

Show more citation formats Show less citations formats

Note that from the first issue of 2016, MDPI journals use article numbers instead of page numbers. See further details here.

Related Articles

Article Metrics

Article Access Statistics

1

Comments

[Return to top]

Molecules EISSN 1420-3049 Published by MDPI AG, Basel, Switzerland RSS E-Mail Table of Contents Alert
Back to Top