scholarly journals Stress Degradation Studies of Riociguat, Development of Validated Stability Indicating Method, Identification, Isolation and Characterization of Degradation Products by LC-HR-MS/MS and NMR Studies

2019 ◽  
Vol 53 (4s) ◽  
pp. s630-s641
Author(s):  
Charu P Pandya ◽  
Sadhana J Rajput
Keyword(s):  
Degradation Products ◽  
Nmr Studies ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
Isolation And Characterization ◽  
Stress Degradation ◽  
Degradation Studies

STABILITY INDICATING RP-HPLC METHOD FOR SEPARATION AND QUANTIFICATION OF RELATED SUBSTANCES OF TICLOPIDINE IN BULK AND PHARMACEUTICAL FORMULATIONS

INDIAN DRUGS ◽  
2021 ◽  
Vol 58 (08) ◽  
pp. 75-78
Author(s):  
B. S. Venkateswarlu ◽  
Prudhvi N. Sai ◽  
Keyword(s):  
Degradation Products ◽  
Pharmaceutical Formulations ◽  
Hplc Method ◽  
Standard Drug ◽  
Stability Indicating ◽  
Stress Studies ◽  
Related Substances ◽  
Stability Indicating Method ◽  
Stress Degradation ◽  
Bulk Drug

A simple, specific, accurate and stable reverse phase liquid chromatographic method was developed for the simultaneous determination of ticlopidine and its related impurities A and B in bulk drug and tablet dosage forms. The analysis has been performed on XTerra C18 column (250 mm×4.6 mm; 5 µ id) and mobile phase containing of methanol and pH 6.8 phosphate buffer in the ratio of 80:20 (V/V). The detection was carried at 228 nm with a flow rate of 1.0 mL/min. The retention times were found to be 8.9, 5.98 and 4.62 min for ticlopidine, impurities A and B, respectively. The method was validated according to ICH guidelines. The method was validated for specificity, precision, linearity, accuracy and robustness. The linearity range of 50-200 µg/mL for ticlopidine and 0.5-2.0 µg/mL for impurity A and B. The recoveries of ticlopidine and impurities were found to be within the range of 98-102 and the % RSD in each spiked level was found to be less than 2. The stress degradation studies confirmed that the method was effectively separate the degradation products and impurities formed in the stress studies and hence the method was found to be stability indicating method. The method can effectively quantify the standard drug ticlopidine and its impurities A and B in bulk drug and pharmaceutical formulations.

Quality by design based development of a selective stability-indicating UPLC method of dolutegravir and characterization of its degradation products by UPLC-QTOF-MS/MS

2015 ◽  
Vol 39 (8) ◽  
pp. 6303-6314 ◽  
Author(s):  
Pradipbhai D. Kalariya ◽  
Prinesh N. Patel ◽  
R. Srinivas ◽  
M. V. N. Kumar Talluri
Keyword(s):  
Method Development ◽  
Quality By Design ◽  
Degradation Products ◽  
Structural Elucidation ◽  
Systematic Method ◽  
Stability Indicating ◽  
Stress Degradation

Systematic method development was performed for dolutegravir and its stress degradation products. Structural elucidation of all degradants was carried out.

scholarly journals Optimization and Establishment of a Validated Stability-Indicating HPLC Method for Study of the Stress Degradation Behavior of Metoprolol Succinate

2010 ◽  
Vol 93 (3) ◽  
pp. 911-916 ◽  
Author(s):  
Mitesh D Phale ◽  
Purnima D Hamrapurkar
Keyword(s):  
Degradation Products ◽  
Hplc Method ◽  
Stress Conditions ◽  
Dihydrogen Phosphate ◽  
Sodium Dihydrogen Phosphate ◽  
Metoprolol Succinate ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
Successful Separation ◽  
Stress Degradation

Abstract A stability-indicating HPLC method has been established for analysis of metoprolol succinate in the presence of products generated in a stress degradation study. The drug was subjected to stress conditions of hydrolysis, oxidation, photolysis, and thermal decomposition. Extensive degradation was found to occur in an alkaline medium and under thermal stress. Minimum degradation was observed in an acidic medium and under photolytic and oxidative stress. Successful separation of the drug from its degradation products formed under stress conditions was achieved on a C18 column using sodium dihydrogen phosphate bufferacetonitrile (70 + 30) mobile phase. The flow rate was 1 mL/min, and the detection wavelength was 274 nm. The method was validated for linearity, range, precision, accuracy, LOQ, and LOD. Because the method effectively separates the drugs from their degradation products, it can be used as a stability-indicating method.

Development and validation of a stability-indicating assay including the isolation and characterization of degradation products of metaxalone by LC-MS

2013 ◽  
Vol 27 (12) ◽  
pp. 1733-1740 ◽  
Author(s):  
R. Nageswara Rao ◽  
Hassan Farah ◽  
Prafulla Kumar Sahu ◽  
Muthumani Janarthan ◽  
Ch. Gangu Naidu
Keyword(s):  
Degradation Products ◽  
Stability Indicating ◽  
Isolation And Characterization ◽  
Development And Validation
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