Method validation and determination of enantiomers and conformers in tofisopam drug substances and drug products by chiral high-performance liquid chromatography and kinetic and thermodynamic study of the interconversion of the conformers

2006 ◽  
Vol 1129 (1) ◽  
pp. 47-53 ◽  
Author(s):  
Mougang Hu ◽  
Ping He ◽  
Yong Chen ◽  
Geoff Carr ◽  
Junan Guo ◽  
...  
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
Method Validation ◽  
High Performance ◽  
Thermodynamic Study ◽  
Drug Products ◽  
Drug Substances ◽  
Kinetic And Thermodynamic Study

scholarly journals Low-level Determination of 4-Hydrazino BenzoicAcid in Drug Substance by High Performance Liquid Chromatography/Mass Spectrometry

2010 ◽  
Vol 7 (2) ◽  
pp. 403-408 ◽  
Author(s):  
S. Harikrishna ◽  
K. Nagabhushana Reddy ◽  
Y. Suresh ◽  
M. Ramakrishna ◽  
M. Sarat ◽  
...  
Keyword(s):  
Mass Spectrometry ◽  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
Benzoic Acid ◽  
High Performance ◽  
Liquid Chromatography Mass Spectrometry ◽  
Monitoring Methods ◽  
Drug Substances ◽  
Ppm Level

HPLC/MS single ion monitoring methods have been evaluated for the determination of trace levels of 4- hydrazino benzoic acid (4-HBA) in drug substances. These 4-HBA have been highlighted as potential genotoxins. HPLC/MS was found to be more promising and limits of quantification was 0.52 ppm. For one drug substances excellent recoveries of 104.6% were obtained at the 0.5 ppm level.

Determination of residual phenylhydrazines in drug substances by high-performance liquid chromatography with pre-column derivatization

2019 ◽  
Vol 11 (48) ◽  
pp. 6146-6152
Author(s):  
Jiaxin Li ◽  
Eyoro Noah Nadine Joelle ◽  
Qian Yang ◽  
Feng Zheng ◽  
Wenyuan Liu ◽  
...  
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Hplc Method ◽  
Drug Substances ◽  
Genotoxic Impurities

A selective, sensitive and general HPLC method with pre-column derivatization was developed for the determination of residual phenylhydrazines (known as genotoxic impurities) in drug substances.

scholarly journals DEVELOPMENT OF ANALYTICAL METHOD FOR THE DETERMINATION OF NINHYDRIN-POSITIVE SUBSTANCES IN AMINO ACIDS BY HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY

2018 ◽  
Vol 11 ◽  
Author(s):  
Srinivasa Rajagopalachari Nk ◽  
Shanmugasundaram P
Keyword(s):  
Amino Acids ◽  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
Amino Acid ◽  
High Performance ◽  
Hplc Method ◽  
Drug Products ◽  
Cation Exchange Column ◽  
The Individual

Aim and Objectives: The aim of the work is focused on the optimization of the high-performance liquid chromatography (HPLC) method for the determination of ninhydrin-positive substances in amino acids using HPLC technique in a single method. Since, most of the amino acids are widely used in the determination of Renal and Nutrition drug products exist independently in the monograph for each amino acid either by TLC or HPLC.Methods: The chromatographic separation was performed using sodium amino acid analysis cation exchange column using Sodium Eluent Na 315, Sodium eluent Na 425, and Sodium Eluent Na 640 as Mobile phase, performed by gradient program with detection of wavelength 570 nm using flow rate as 0.4 mL/min. The method has been evaluated using post-column derivatization technique (HPLC/Pinnacle PCX).Results: All the amino acids were eluted correspondingly at the individual retention time and the method shall be validated as per the ICH Q2R1 Guideline.Conclusion: The method has been successfully evaluated and developed for the analytical applications.

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