- |||||||||| Derazol DDR (dexrabeprazole) / Neutec, tenatoprazole (sTU-199) / Mitsubishi Tanabe
Review, Journal: Determination of Proton Pump Inhibitors by Spectrophotometric, Chromatographic and by Hyphenated Techniques: A Review. (Pubmed Central) - Oct 27, 2021 The examined literature survey addressed chromatographic (HPLC and UPLC) and UV visible spectrophotometric methods with LC-MS/MS methods used in pure forms, pharmaceutical formulations, and human plasma and other biological fluids for their estimation. In case of validation parameters mostly Linearity, Recovery study, LOD and LOQ was considered and mentioned.
- |||||||||| lansoprazole / Generic mfg.
Journal: Chiral separation of lansoprazole and rabeprazole by capillary electrophoresis using dual cyclodextrin systems. (Pubmed Central) - Mar 31, 2020 The optimized methods (25 mM phosphate buffer, pH = 7.0, 10 mM sulfobutyl-ether-β-CD/20 mM γ-CD, +20 kV voltage; 17°C temperature; 50 mbar/3 s injection, detection at 210 nm for lansoprazole; 25 mM phosphate buffer, pH = 7.0, 15 mM sulfobutyl-ether-β-CD/30 mM γ-CD, +20 kV voltage; 18°C temperature; 50 mbar/3 s injection, detection at 210 nm for rabeprazole) provided baseline separation for lansoprazole (Rs = 2.91) and rabeprazole (Rs = 2.53) enantiomers with favourable migration order (in both cases the S-enantiomers migrates first). The optimized methods were validated according to current guidelines and proved to be reliable, linear, precise and accurate for the determination of 0.15% distomer as chiral impurity in dexlansoprazole and dexrabeprazole samples .
- |||||||||| Derazol DDR (dexrabeprazole) / Neutec
Trial completion: The Effect of Dexrabeprazole on Intragastric and Intraesophageal Acidity (clinicaltrials.gov) - Aug 24, 2017 P4, N=12, Completed, The optimized methods were validated according to current guidelines and proved to be reliable, linear, precise and accurate for the determination of 0.15% distomer as chiral impurity in dexlansoprazole and dexrabeprazole samples . Recruiting --> Completed
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