A CRITICAL REVIEW ON BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF FEW ONCOLOGY DRUGS BY USING LC-MS-MS
Konatham Teja, Kumar Reddy, Kumaraswamy Gandla, P. Vijaya Babu, Vinay Kumar Chakravarthy, Pavuluri Chandrasekhar, Rajinikanth Sagapola, Mohammad Mahdi Moeina, Aziza El Beqqali B, Mohamed Abdel-Rehim, D Zimmer, J Schuhmacher, D Zimmer, F Tesche, V Pickard, E Stokvis, H Rosing, J Beijnen, T Annesley, B Matuszewski, M Constanzer, C Chavez-Eng, R Weaver, R Riley, A Eeckhaut, K Lanckmans, S Sarre, I Smolders, Y Michotte, M Ahnoff, A-C Nystrm, F Schweikart, A Ekdahl, M Van Hout, H Niederlnder, R De Zeeuw, G De, Jong, D Remane, M Meyer, F Peters, D Wissenbach, H Maurer, Rahul Singh, Ashok Shakya, K Nataraj, Shobhanak, * Menon, Bhoomikar Mistry, Kuldeepv Joshi, Pinkeshg Sutariya, Ravindrav, Guanyu Chen, Darren Svirskis, Jingyuan Wen, Taranjit Kaur, Kaur Sukhjinder, V Sunil, Lanke1, Knv Rao, M Raja, D Banji, Balaji1, * Sunil V Lanke, Sajid Syed Shahnawaz, Dhramveer Singh Shekhawat, Nishikumarniture, Che Radhiah, Nurul Rusli, Syazwaninadirah, M Madhuri1, L Sangeetha Kumari1, P Susmitha1, Y Lakshmi Gayatri1, S Sahoo, Bruno Charliera, Luigi Marinoc, Fabrizio Dal Piazb, Marine Pingeonc, Albino Coglianesec, Barbara Izzod, Bianca Seriob, Carmine Sellerib, Amelia Filippellib, Viviana Izzo, Sumanta Sabyasachi Biswal1, Mondal1, Sridhar Veeraraghavana, *, Srikant Viswanadhaa, Sandhyaranichennupati, Manikantakumargollaa Santhoshkumarnallaa, Alessandro Di, Michele, Unknown author, Anjana Vaghela, Ashok Patel, Ajay Patel, Amit Vyas, D Wells
Abstract
A protocol is used to detect and measure biomolecules and metabolites in human and animal tissues using bimolecular methods. The biosanalinity method is effective at determining the number of drugs and metabolites in a biological system. New methods, the validation of existing procedures, and the analysis of samples are one of the prominent tasks for bioanalysis. Above all, a compound can be measured using several methods and identified by different methods of analysis. Drugs may be tested by several extraction techniques, including liquid extraction, solid-phase extraction, and protein precipitation in complex plasma and biological samples. To determine how the environment, matrix, or procedures impact the matrix estimation to the time of the analysis, all steps in the process must be investigated. The more detailed study of drug products can be performed with higher-pressure analytical techniques, such as high-extraction (HPLC), liquid chromatography coupled with double-mass spectrometry (LCMS/MS), and ultra-performance Liquid chromatography (UPLC). Both of them have flaws and strengths. At present, HPLC and GC usually perform biolysis. The parameters are linearity, repeatability, accuracy, selectivity, and continuity. We are proposing the development and validation of bioanalytical systems to assist in the quality assurance of drugs.