STABILITY-INDICATING HPLC METHOD FOR THE DETERMINATION OF RELATED SUBSTANCES IN LANSOPRAZOLE INTERMEDIATE

Balaji  Nagarajan; Gunasekar Manoharan

doi:10.29121/ijoest.v6.i3.2022.329

Authors

Dr. Balaji Nagarajan New Jersey Bioscience Centre, 685, North Brunswick, New Jersey, 08902, USA.
Dr. Gunasekar Manoharan New Jersey Bioscience Centre, 685, North Brunswick, New Jersey, 08902, USA.

DOI:

https://doi.org/10.29121/ijoest.v6.i3.2022.329

Keywords:

Lansoprazole Intermediate, HPLC, Validation, Impurities, Stress Study

Abstract

A novel, reversed-phase liquid chromatographic method was developed and validated for the determination of related substances in lansoprazole intermediate. 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/triethylamine and acetonitrile delivered in gradient mode at a flow rate of 1.0 mL/min at 260 nm. The resolution between lansoprazole intermediate (LAN20) and its impurities (LAN20-I & LAN20-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 intermediate and its related substances. The detection and quantitation limits of lansoprazole intermediate and its impurities are 0.01% and 0.005%. This method indicates that the recovery at different levels is 90 to 110% accurate. The test solution was stable in the diluent for 48 h and subjected to stress conditions. The mass balance was close to 99.5%.

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