The present study determines the related substances in
lansoprazole intermediate by using stability-indicating HPLC method.
Lansoprazole intermediate is the critical raw material for synthesizing the
drug substance, lansoprazole. The purity of the lansoprazole intermediate
determines the quality of the lansoprazole drug substance with high yield in
the synthetic process during the manufacturing. A novel, reversed-phase liquid
chromatographic method was developed and validated to determine related
substances in the lansoprazole intermediate. The symmetric peak shape was on a
C18 stationary phase with the dimensions of 250 mm column length, 4.6 mm as
internal diameter, and 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 the lansoprazole intermediate
and its impurities 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 related substances. Lansoprazole
Intermediate's detection and quantitation limits and impurities are 0.01% and
0.005%, respectively. This method indicates that the recovery at different
levels is 90 to 110% accurate. The test solution was stable in the diluent for
48 hours. The results of forced degradation studies implied that the
Lansoprazole Intermediate was sensitive to acid/base hydrolysis and oxidation
conditions, and the mass balance was close to 99.5%. This study used the HPLC
system Agilent Technologies 1200, a quaternary pump, an autosampler, and a
diode array detector. The chromatographic output signal was monitored and processed
by Empower software on an Intel Core i5 computer (Dell).
Author(s) Details:
Balaji Nagarajan,
New Jersey Bioscience Centre, 685, North Brunswick, New Jersey,
08902, USA.
Gunasekar
Manoharan,
New
Jersey Bioscience Centre, 685, North Brunswick, New Jersey, 08902, USA.
Please see the link here: https://stm.bookpi.org/ACPR-V6/article/view/13467
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