Syed Salman Ali1, Brijesh Garg2*, Jasmeet Kaur3, Sukhmeet Tangri4, R. Sahaya Mercy Jaquline5, Sumayya Khan6, Richa Garg7, Mohamad Taleuzzaman8
1. Lloyd Institute of management and Technology, Knowledge Park-II, Greater Noida, Uttar Pardesh, India. 201306
2.PepGen, Boston, Massachusetts, United States of America.
3. School of Pharmaceutical Sciences and Research, Jamia Hamdard, New Delhi, 110062, India.
4. Department of Pharmaceutics, School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi, 110062. India.
5. Department of Pharmacognosy and Phytochemistry, School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi, 110062, India.
6.Department of Pharmacology, Faculty of Pharmacy, Maulana Azad University, Village Bujhawar, Tehsil Luni, Jodhpur 342008, Rajasthan, India.
7.AbbVie Bioresearch Center, Worcester, Massachusetts, United States of America.
8.Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Maulana Azad University, Village Bujhawar, Tehsil Luni, Jodhpur 342008, Rajasthan, India.
In the last few decades, the hyphenated analytical techniques including liquid chromatography (LC) in combination with a mass spectrometer (MS) i.e., LC/MS, have made a major impact in pharmaceutical drug discovery and development. LC-MS hase been routinely used in pharmaceutical formulation development for drug substance and drug product characterization, molecular weight and fragmentation patterns determination, breakdown studies, and to identify impurities and degradation products. Recent advancements in LC-MS instrumentation, have allowed the technique to be implemented in several indications i.e., cancer, cardiovascular, respiratory, neurological, rare diseases etc. across preclinical (in vitro and in vivo) and clinical projects to evaluate pharmacokinetic and pharmacodynamic factors. LC-MS has overcome the sensitivity and dynamic range challenges to successfully identify and characterize drug molecules to help projects that use small molecules, biologics, and gene and cell therapy/editing platforms as drug modalities. This technique may provide several advantages over other analytical approaches including specificity, multiplexing, precision to quantify drug analyte or a biomarker in a variety of matrices like blood (plasma/serum), tissue, cerebrospinal fluid, urine, cells etc. In this review, we have highlighted LC-MS applications to study pharmaceutical formulations, pharmacokinetics and pharmacodynamics involving small molecule modality.
Keywords: LC-MS/MS, mass spectrometry, pharmacokinetics, pharmacodynamics, pharmaceutical formulation