Characterization of solution stress degradation products of aliskiren and prediction of their physicochemical and ADMET properties
Tài liệu tham khảo
Bruckner, 2004, Organic mechanisms reactions, stereochemistry and synthesis, 321
Govindu, 2014, Stability indicating high performance liquid chromatographic method for the quantification of aliskiren hemifumarate and its related substances, Der Pharma Chemica., 6, 290
Gupta, 2015, Development and validation of stability indicating RP-HPLC method for determination of aliskiren in bulk and pharmaceutical dosage forms, Int. J. Chem. Pharm. Anal., 2, 1
ICH Q1A(R2), 2003
ICH Q1B, 1996
Müller, 2008, Aliskiren-mode of action and preclinical data, J. Mol. Med., 86, 659, 10.1007/s00109-008-0330-6
Narayanam, 2014, Critical practical aspects in the application of liquid chromatography-mass spectrometric studies for the characterization of impurities and degradation products, J. Pharm. Biomed. Anal., 87, 191, 10.1016/j.jpba.2013.04.027
Pool, 2007, Direct renin inhibition: focus on aliskiren, J. Manag. Care Pharm., 13, 21, 10.18553/jmcp.2007.13.s8-b.21
Prasad, 2017, Method development and validation of aliskiren hemifumarate in bulk drug manufacturing of active pharmaceuticals ingredient by reverse phase high pressure liquid chromatography, World J. Pharm. Pharm. Sci., 6, 805
Sangoi, 2011, Determination of aliskiren in tablet dosage forms by a validated stability-indicating RP-LC method, J. Chromatogr. Sci., 49, 170, 10.1093/chrsci/49.2.170
Singh, 2000, Guidance on conduct of stress tests to determine inherent stability of drugs, Pharm. Technol. Online., 24, 1
Singh, 2012, A critical review on the use of modern sophisticated hyphenated tools in the characterization of impurities and degradation products, J. Pharm. Biomed. Anal., 69, 148, 10.1016/j.jpba.2012.03.044
Theodorou, 2015, A mild alkaline hydrolysis of N- and N,N-substituted amides and nitriles, ARKIVOC, 101, 10.3998/ark.5550190.p009.205
Uday Kumar, 2013, Identification, synthesis and characterization of related substances of aliskiren hemifumarate, an antihypertensive drug, Chem. Biol. Interface, 3, 304
Waldmeier, 2007, Absorption, distribution, metabolism, and elimination of the direct renin inhibitor aliskiren in healthy volunteers, Drug Metab. Dispos., 35, 1418, 10.1124/dmd.106.013797
WHO, 2009