Abstract
Symmetric peak shape was on a C18 stationary phase with the dimensions of 250 mm column length, 4.6 mm as internal diameter, 5 microns particles with an economical and straightforward mass-compatible mobile phase combination of formic acid and acetonitrile delivered in gradient mode at a flow rate of 1.0 mL/min at 260 nm. The resolution between Lansoprazole sulphide (LAN30) and its impurities (LAN30-I & LAN30-II) in the developed method was more than 2.0, indicating a significant separation. Regression analysis shows a correlation coefficient greater than 0.999 for Lansoprazole sulphide and its related substances. The detection limits of Lansoprazole sulphide and its impurities are 0.003%, 0.01%, and 0.01%; the quantitation limits are 0.01%, 0.03%, and 0.03% for LAN30, LAN30-I, and LAN30-II. This method indicates that the recovery at different levels is 95 to 105% accurate. The test solution was stable in the diluent for 48 h at refrigerator temperature and subjected to stress conditions. The mass balance was close to 99.5%.
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