Stability-indicating HPLC method for the determination of related substances in lansoprazole sulphide
New Jersey Bioscience Centre, 685, North Brunswick, New Jersey, USA.
Research Article
International Journal of Science and Technology Research Archive, 2022, 03(01), 001–007.
Article DOI: 10.53771/ijstra.2022.3.1.0053
Publication history:
Received on 21 May 2022; revised on 26 June 2022; accepted on 28 June 2022
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%.
Keywords:
Lansoprazole Sulphide; High-Performance Liquid chromatograph (HPLC); Validation; Stress Study
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