RECENT METHOD DEVELOPMENT BY ANALYTICAL TECHNIQUES OF NEW FDA APPROVED RUGS IN 2021
Keywords:Analytical method, FDA approved drugs, HPLC, UV-VIS, HPTLC, LC-MS
In this present situation increase in the number of diseases has been observed and several new medications are invented and have been developed to treat various disorders, which are approved by FDA. But before these drugs come to market it must undergo several procedures. The validation and analytical process of a new drug development helps in ensuring its purity and reliability. This process involves the use of various analytical techniques to collect data about the drug. This review includes various types of analytical techniques such as ultraviolet-visible spectrophotometric and some chromatography methods (High-performance thin-layer chromatography, High-performance liquid chromatography, gas chromatography), hyphenation techniques such as LC-MS of the newly approved drug in the year of 2021 have been discussed.
Ravisankar P, Gowthami S, Rao GD. A review on analytical method development 1. Indian J Res Pharm Biotechnol. 2014;2(3):1183-95.
Sharma S, Singh N, Ankalgi AD, Rana A, Ashawat MS. Analytical techniques for method development and validation of pharmaceuticals: a review. Journal of Drug Delivery and Therapeutics Modern Trends. 2021;11:121-30.
Ozkan SA. Analytical method validation: the importance for pharmaceutical analysis. Pharm Sci. 2018;24(1):1-2. doi: 10.15171/PS.2018.01.
Hussain AF. UV-visible spectrometry (December); 2019.
Hplc C, P SLR. Research and reviews. A review on chromatography with high-performance liquid. J Pharm Anal 2015;4(1):1-15.
Deepthi R. Instrumentation and future prospects of HPTLC-A. World Journal of Pharmaceutical Research. 2021;10(6):650-61.
Saibaba S. Mini review on LC/MS techniques; 2017.
Pratima NA, Gadikar RL. Liquid chromatography-mass spectrometry and its applications: A brief. Upine Publishers 2018;1(1):26-34.
Ponnekanti K, Sunitha K. Analytical method development and validation of rilpivirine by RP-HPLC method. Int J Pharmacol Res. 2021;13(3):173-8.
Vejendla A, Talari S, Moturu R, Boddapati SNM, Kola AE. Method development and validation for cabotegravir and rilpivirine by using HPLC and its degradants are characterized by LCMS and FTIR. Futur J Pharm Sci. 2021;7(1). doi: 10.1186/s43094-021-00355-8.
Handy R, Trepanier D, Scott G, Foster R, Freitag D. Development and validation of a LC/MS/MS method for quantifying the next generation calcineurin inhibitor, voclosporin, in human whole blood. J Chromatogr B Analyt Technol Biomed Life Sci. 2008;874(1-2):57-63. doi: 10.1016/j.jchromb.2008.08.023, PMID 18815080.
Rafi S, Rambabu K. Stability demonstrating validated high pressure liquid chromatographic method for the determination of Trilaciclib in bulk and pharmaceutical formulation. J Pharm Res Int. 2021;33:173-81. doi: 10.9734/jpri/2021/v33i44A32604.
Jose TJ, Subbareddy Y, Sankar K. Method development and validation of tivozanib by using rp-hplc in bulk and pharmaceutical dosage form. Int J App Pharm. 2021;13(6):199-205. doi: 10.22159/ijap.2021v13i6.42701.
Bruin MAC, Rosing H, Lucas L, Wang J, Huitema ADR, Schinkel AH, Beijnen JH. Development and validation of an LC-MS/MS method with a broad linear dynamic range for the quantification of tivozanib in human and mouse plasma, mouse tissue homogenates, and culture medium. J Chromatogr B Analyt Technol Biomed Life Sci. 2019;1125(May):121723. doi: 10.1016/j.jchromb.2019.121723, PMID 31352204.
Saka C. Analytical strategies for the determination of norepinephrine reuptake inhibitors in pharmaceutical formulations and biological fluids. Crit Rev Anal Chem. 2016;46(1):40-66. doi: 10.1080/10408347.2014.948679, PMID 26857446.
Syed R, Kantipudi R. New validated reverse-phase ultra-performance liquid chromatography method for drospirenone and estetrol in active pharmaceutical Ingredient and tablet form and its stress studies. J Appl Pharm Sci. 2021;11(9):106-12. doi: 10.7324/JAPS.2021.1101015.
Yarlagadda SRAO, Mannam SRAO, Jampani BP. Original article stability-indicating and cost-effective analytical method development and validation of Sotorasib by using Rp-Hplc. Int J App Pharm. 2021;13(5):1-6.
Markose M, Mallurwar SR. Validated HPLC-MS/MS method for the quantitation of AMG 510, a KRAS G12C inhibitor, in mouse plasma and its application to a pharmacokinetic study in mice. Biomed Chromatogr. 2021 Apr;35(4):e5043. doi: 10.1002/bmc.5043.
Retmana IA, Loos NHC, Schinkel AH, Beijnen JH, Sparidans RW. Quantification of KRAS inhibitor sotorasib in mouse plasma and tissue homogenates using liquid chromatography-tandem mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci. 2021;1174(Apr):122718. doi: 10.1016/ j.jchromb.2021.122718.
Mostafa GAE, Kadi AA, Almasoud N, Attwa MW. Al-shakliah NS, Alrabiah H. LC-MS/MS method for the quantification of the anti-cancer agent infigratinib: application for estimation of metabolic stability in human liver microsomes. J Chromatogr B. 2021;1179(Apr). PMID 122806.
Rohde G, Loewen S, Heinig R. Determination of finerenone–a novel, selective, nonsteroidal mineralocorticoid receptor antagonist–in human plasma by high-performance liquid chromatography-tandem mass spectrometry and its application to a pharmacokinetic study in venous and capill. J Chromatogr B. 2021;1172(Sep 2020). PMID 122643.
Valverde O, Eve E. Determination of an optimal dosing regimen for fexinidazole, a novel oral drug for the treatment of human African trypanosomiasis: first-in-human studies; 2014. p. 565-80.
Manuscript A, Onlinefirst P. Downloaded from cancer discovery. aacrjournals. org on Dec 29, Vol. 857; 2021.
Raviteja G, Rambabu K. High pressure liquid chromatographic method for the determination of Mobocertinib in pharmaceutical dosage form and study of its degradation. JPRI. 2021;33:154-62. doi: 10.9734/jpri/2021/v33i46B32927.
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