Enantioselective separation of eight antihistamines with α1-acid glycoprotein-based chiral stationary phase by HPLC: Development and validation for the enantiomeric quality control

2019 ◽  
Vol 176 ◽  
pp. 112803 ◽  
Author(s):  
Bolin Zhu ◽  
Mengyao Xue ◽  
Beibei Liu ◽  
Qing Li ◽  
Xingjie Guo
Keyword(s):  
Quality Control ◽  
Stationary Phase ◽  
Chiral Stationary Phase ◽  
Enantioselective Separation ◽  
Acid Glycoprotein ◽  
Development And Validation

Enantioselective separation of thalidomide on an immobilized α1-acid glycoprotein chiral stationary phaseglycoprotein chiral stationary phase

2000 ◽  
Vol 52 (7-8) ◽  
pp. 455-458 ◽  
Author(s):  
C. Álvarez ◽  
J. A. Sánchez-Brunete ◽  
S. Torrado-Santiago ◽  
R. Cadórniga ◽  
J. J. Torrado
Keyword(s):  
Stationary Phase ◽  
Chiral Stationary Phase ◽  
Enantioselective Separation ◽  
Acid Glycoprotein

scholarly journals Direct Stereoselective Method Development and Validation of Elagolix on Zwitterionic Chiral Stationary Phase by High-Pressure Liquid Chromatography

2020 ◽  
pp. 517-524
Author(s):  
Thirupathi Choppari ◽  
Srinivasu Gunnam ◽  
Lakshmi Narayana Chennuru ◽  
Parameswara Murthy Cherla
Keyword(s):  
Stationary Phase ◽  
Chiral Stationary Phase ◽  
Method Development ◽  
Drug Product ◽  
Research Work ◽  
Cinchona Alkaloid ◽  
Chromatographic Technique ◽  
Ich Guidelines ◽  
Development And Validation ◽  
High Degree

A specific, sensitive and accurate chiral technique has been developed for the quantification of elagolix enantiomer in a drug product. The present research work represents the development and validation of chromatographic technique for the separation of elagolix enantiomers on a chiral stationary phase (CSP) comprising a zwitterionic selector derived from cinchona alkaloid and sulfonic acid CHIRALPAK ZWIX (+)  under isocratic condition containing 50mM Acetic acid and 25mM diethyl amine in water and methanol in the ratio of 02:98 v/v with 0.5 ml min-1 flow rate. Temperature of the column was monitored at 40°C with a resolving factor more than 3.2. The eluted compounds were monitored at 275 nm. The optimized method has high degree of selectivity with lower limiting values of detection and quantitation and were found to be 2.0 ng/ml and 7.5 ng/ml, respectively for the enantiomeric chiral impurity. The developed method was subjected for validation as per the ICH guidelines, produced good findings regarding specificity, accuracy, precision, robustness and linearity.

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