Forced degradation of lafutidine and characterization of its non-volatile and volatile degradation products using LC-MS/TOF, LC-MSn and HS-GC-MS

2015 ◽  
Vol 39 (12) ◽  
pp. 9679-9692 ◽  
Author(s):  
Shah Kinalkumar Pravinchandra ◽  
Moolchand Kurmi ◽  
Sanjay Kumar ◽  
Saranjit Singh

The study involved establishment of the intrinsic degradation behaviour of lafutidine under hydrolytic, oxidative and photolytic conditions.

2018 ◽  
Vol 42 (23) ◽  
pp. 19113-19128
Author(s):  
Shandilya Mahamuni Baira ◽  
Padmini Gunupudi ◽  
Vigjna Abbaraju ◽  
Srinivas R. ◽  
M. V. N. Kumar Talluri

The present study describes the LC/MS/MS characterization of degradation products of cobicistat and atazanavir.


RSC Advances ◽  
2015 ◽  
Vol 5 (116) ◽  
pp. 96117-96129 ◽  
Author(s):  
Moolchand Kurmi ◽  
Vijaya Madhyanapu Golla ◽  
Sanjay Kumar ◽  
Archana Sahu ◽  
Saranjit Singh

The investigation established the intrinsic degradation behaviour of tenofovir disoproxil fumarate in solid and solution states.


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.


2014 ◽  
Vol 37 (4) ◽  
pp. 368-375 ◽  
Author(s):  
Thippani Ramesh ◽  
Pothuraju Nageswara Rao ◽  
Ramisetti Nageswara Rao

2019 ◽  
Vol 43 (19) ◽  
pp. 7294-7306 ◽  
Author(s):  
G. Shankar ◽  
Roshan M. Borkar ◽  
Suresh Udutha ◽  
M. Kanakaraju ◽  
G. Sai Charan ◽  
...  

Omeprazole (OMP), a prototype proton pump inhibitor used for the treatment of peptic ulcers and gastroesophageal reflux disease (GERD), was subjected to forced degradation studies as per ICH guidelines Q1A (R2).


2018 ◽  
Vol 26 (4) ◽  
pp. 467-480 ◽  
Author(s):  
Robert Skibiński ◽  
Jakub Trawiński ◽  
Łukasz Komsta ◽  
Diana Murzec

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