Stability Indicating LC-DAD Method for Determination of Nadifloxacin and Characterization of Its Degradation Products by LC–ESI–MS/MS

2018 ◽  
Vol 81 (3) ◽  
pp. 469-478 ◽  
Author(s):  
Nishant Salunke ◽  
Nancy Pandita
Keyword(s):  
Degradation Products ◽  
Stability Indicating ◽  
Esi Ms

Using an innovative quality-by-design approach for the development of a stability-indicating UPLC/Q-TOF-ESI-MS/MS method for stressed degradation products of imatinib mesylate

RSC Advances ◽  
2016 ◽  
Vol 6 (16) ◽  
pp. 13050-13062 ◽  
Author(s):  
Zhihui Ren ◽  
Xiaoxi Zhang ◽  
Haiyuan Wang ◽  
Xinghua Jin
Keyword(s):  
Simultaneous Determination ◽  
Imatinib Mesylate ◽  
Quality By Design ◽  
Degradation Products ◽  
Design Approach ◽  
Design Expert ◽  
Stability Indicating ◽  
Esi Ms ◽  
Quality By Design Approach

Chromatography modeling softwares (DryLab®2000 plus and Design Expert®​8.0.6) were used to develop a stability indicating UPLC/Q-TOF-ESI-MS/MS method for the simultaneous determination of stressed degradation products of imatinib mesylate.​

Determination of lumiracoxib by a validated stability-indicating MEKC method and identification of its degradation products by LC-ESI-MS studies

2011 ◽  
Vol 34 (15) ◽  
pp. 1867-1874 ◽  
Author(s):  
Maximiliano S. Sangoi ◽  
Micheli Wrasse-Sangoi ◽  
Paulo R. Oliveira ◽  
Larissa S. Bernardi
Keyword(s):  
Degradation Products ◽  
Stability Indicating ◽  
Esi Ms

Stability Indicating Liquid Chromatographic Method for the Determination of Fenofibrate and its Application to Kinetic Studies

2013 ◽  
Vol 5 (4) ◽  
pp. 1866-1874
Author(s):  
K. Srinivasa Rao ◽  
Keshar N K ◽  
N Jena ◽  
M.E.B Rao ◽  
A K Patnaik
Keyword(s):  
Degradation Products ◽  
Kinetic Studies ◽  
Pharmaceutical Formulations ◽  
Assay Method ◽  
Pharmaceutical Dosage Form ◽  
Stability Indicating ◽  
Zero Order Kinetics ◽  
Relative Standard ◽  
Liquid Chromatographic

A stability-indicating LC assay method was developed for the quantitative determination of fenofibrate (FFB) in pharmaceutical dosage form in the presence of its degradation products and kinetic determinations were evaluated in acidic, alkaline and peroxide degradation conditions. Chromatographic separation was achieved by use of Zorbax C18 column (250 × 4.0 mm, 5 μm). The mobile phase was established by mixing phosphate buffer (pH adjusted 3 with phosphoric acid) and acetonitrile (30:70 v/v). FFB degraded in acidic, alkaline and hydrogen peroxide conditions, while it was more stable in thermal and photolytic conditions. The described method was linear over a range of 1.0-500 μg/ml for determination of FFB (r= 0.9999). The precision was demonstrated by relative standard deviation (RSD) of intra-day (RSD= 0.56– 0.91) and inter-day studies (RSD= 1.47). The mean recovery was found to be 100.01%. The acid and alkaline degradations of FFB in 1M HCl and 1M NaOH solutions showed an apparent zero-order kinetics with rate constants 0.0736 and 0.0698  min−1 respectively and the peroxide degradation with 5% H2O2 demonstrated an apparent first-order kinetics with rate constant k = 0.0202 per min. The t1/2, t90   values are also determined for all the kinetic studies. The developed method was found to be simple, specific, robust, linear, precise, and accurate for the determination of FFB in pharmaceutical formulations.  

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