Identification and characterization of forced degradation products of paliperidone using LC–APCI–Ion Trap–MS

2013 ◽  
Vol 6 (1) ◽  
pp. 39-47 ◽  
Author(s):  
Sanjay D. Sawant ◽  
Vijaya U. Barge
Keyword(s):  
Ion Trap ◽  
Degradation Products ◽  
Forced Degradation ◽  
Identification And Characterization

Identification and characterization of degradation products of indacaterol using liquid chromatography/mass spectrometry

2020 ◽  
Vol 26 (6) ◽  
pp. 425-431
Author(s):  
Naga Veera Yerra ◽  
S Babu Dadinaboyina ◽  
LSSN Vigjna Abbaraju ◽  
MVN Kumar Talluri ◽  
Jagadeshwar Reddy Thota
Keyword(s):  
Degradation Products ◽  
Thermal Conditions ◽  
Active Pharmaceutical Ingredient ◽  
Stress Conditions ◽  
Chronic Obstructive ◽  
Forced Degradation ◽  
Obstructive Pulmonary Disease ◽  
Guide Lines ◽  
Identification And Characterization

Indacaterol (IND), 5-[2-[(5,6-Diethyl-2,3-dihydro-1H-inden-2-yl)amino]-1-hydroxyethyl]-8-hydroxyquinolin-2(1H)-one, is an active pharmaceutical ingredient (API) which is used to treat chronic obstructive pulmonary disease (COPD). We followed the International Council for Harmonization (ICH) guide lines to study the degradation behavior of IND under various stress conditions. Stressed degradation of the drug was performed under hydrolytic (alkaline, acidic and neutral), photolytic, oxidative and thermal conditions. Identification and characterization of IND and its forced degradation products (DPs) were demonstrated by using LC-HRMS and MS/MS method. A total of three DPs (DP1-DP3) were identified and characterized. The IND was found to be stable under photolytic, oxidative and thermal conditions, whereas it produced three DPs in acidic, basic and neutral hydrolytic stress conditions.

scholarly journals Identification and Characterization of Forced Degradation Products of Moexipril Using LC-ESI-MS/Q-TOF

2018 ◽  
Vol 07 (03) ◽  
Author(s):  
Rajesh Babu KB ◽  
Nagaraju P ◽  
Rajendra ◽  
Gowri Sankar D ◽  
Seshagiri Rao JVLN ◽  
...  
Keyword(s):  
Degradation Products ◽  
Forced Degradation ◽  
Esi Ms ◽  
Identification And Characterization

Identification and characterization of forced degradation products of vortioxetine by LC/MS/MS and NMR

2020 ◽  
Vol 188 ◽  
pp. 113442
Author(s):  
Nagarjuna Chary Ragi ◽  
Ganga Reddy Velma ◽  
Pavan Kumar Pallerla ◽  
Sana Siddiqua ◽  
Veeresham Alugonda ◽  
...  
Keyword(s):  
Degradation Products ◽  
Forced Degradation ◽  
Identification And Characterization

Synthesis and Characterization of Potential and Degraded Impurities of Regadenoson

2020 ◽  
Vol 16 (8) ◽  
pp. 1130-1139
Author(s):  
Singaram Sathiyanarayanan ◽  
Chidambaram Subramanian Venkatesan ◽  
Senthamaraikannan Kabilan
Keyword(s):  
Mass Spectra ◽  
Degradation Products ◽  
Hplc Method ◽  
Forced Degradation ◽  
Spectroscopic Techniques ◽  
A2a Adenosine Receptor ◽  
Degradation Study ◽  
Related Substances ◽  
Adenosine Receptor Agonist

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.

Sign in / Sign up

Export Citation Format

Share Document