Forced degradation of fingolimod: Effect of co-solvent and characterization of degradation products by UHPLC-Q-TOF–MS/MS and 1H NMR

2015 ◽  
Vol 115 ◽  
pp. 388-394 ◽  
Author(s):  
Prinesh N. Patel ◽  
Pradipbhai D. Kalariya ◽  
S. Gananadhamu ◽  
R. Srinivas
RSC Advances ◽  
2015 ◽  
Vol 5 (27) ◽  
pp. 21142-21152 ◽  
Author(s):  
Prinesh N. Patel ◽  
D. Rajesh Kumar ◽  
S. Gananadhamu ◽  
R. Srinivas

TVT was subjected to forced degradation under hydrolysis, oxidation, dry heat and photolysis conditions and the degradation products (DPs) formed have been characterized through UPLC-PDA and UPLC-Q-TOF-MS/MS studies.


2021 ◽  
Vol 11 (4) ◽  
pp. 563-579
Author(s):  
Amrej Singh Yadav ◽  
Aishwarya Prabha ◽  
Divya Dornala ◽  
Debasish Swain ◽  
Dilep Kumar Sigalapalli ◽  
...  

2014 ◽  
Vol 49 (5) ◽  
pp. 380-391 ◽  
Author(s):  
Pradipbhai D. Kalariya ◽  
B. Raju ◽  
Roshan M. Borkar ◽  
Deepak Namdev ◽  
S. Gananadhamu ◽  
...  

2015 ◽  
Vol 50 (7) ◽  
pp. 918-928 ◽  
Author(s):  
Prinesh N. Patel ◽  
Pradipbhai D. Kalariya ◽  
Mahesh Sharma ◽  
Prabha Garg ◽  
M. V. N Kumar Talluri ◽  
...  

2020 ◽  
Vol 16 (8) ◽  
pp. 1130-1139
Author(s):  
Singaram Sathiyanarayanan ◽  
Chidambaram Subramanian Venkatesan ◽  
Senthamaraikannan Kabilan

Background: Regadenoson is an A2A adenosine receptor agonist that is a coronary vasodilator and commonly used as a pharmacologic cardiac stressing agents. Methods: HPLC method was used for the analysis of related substances. The degraded impurities during the process were isolated and characterized by IR, Mass and NMR spectral analysis. Results: Forced degradation study of regadenoson under conditions of hydrolysis (neutral, acidic and alkaline) and oxidations suggested in the ICH Q1A(R2) was accomplished. The drug showed significant degradation under all the above conditions. On the whole, five novel degradation products were found under diverse conditions along with process related impurities which were not reported earlier. Conclusion: All the degradation products were well characterized by using advanced spectroscopic techniques like IR, 1H NMR, 13C NMR and Mass spectra. The identification of these impurities will be productive for the quality control during the production and stability behavior of the regadenoson drug substance.


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