Method validation of lansoprazole optical isomer analysis on lux cellulose column

Abstract

A high performance liquid chromatographic (HPLC) method was developed for the chiral separation of lansoprazole. The survey was carried out on 3 Lux cellulose-1, Lux cellulose-2 and Lux ​​cellulose-3 isolate separating columns. The two enantiomers were separated on a the Lux  Cellulose-1 column. The mobile phase was n-hexane-isopropanol - formic acid mixture (80:20:0.1) (v/v/v), UV detection was at 285nm. The resolution of the enantiomers was greater than 3.5. The range of quantification for both enantiomers was 150-1200µg/ml. Relative standard deviation of the method was below 2% (n=6), and the recovery range was 98-102%. The method meets the validation requirements for specificity, linear range, accuracy, detection limit and quantitative limit in accordance with ICH (International Council for Harmonization) guidelines and is suitable for lansoprazole active ingredient quality control.