Stability Indicating Assay Method for Lansoprazole a Comparative Study by UPLC and HPLC

Lansoprazole is indicated for treatment of ulcers of the stomach and reflux Zollinger – Ellison’s syndrome, treatment of H. pylori infections alongside antibiotics. Lansoprazole is belongs to the class of a proton pump inhibitors. A simple, Isocratic, rapid and selective RP-UPLC method was developed for the quantification of Lansoprazole in active pharmaceutical ingredients (API’S) using a simple mobile phase of Water: Acetonitrile: Triethyl amine in the raio of 50:50:1 and the pH of the mobile phase was adjusted to 6.8 with ortho phosphoric acid. Water: Acetonitrile: Triethyl amine in the ratio of 50:50:1 and the pH of the mobile phase was adjusted to 10.5 with ortho phosphoric acid was used as a sample diluent at a flow rate of 0.70 mL/min. The chromatographic separation was achieved on a Acquity uplc HSS T3 column of dimension 2.1 X 100 mm, 1.8 μm. The column and sample compartment temperatures were maintained at ambient. UV detector was monitored at 285 nm. The retention time (RT) of Lansoprazole was about 2 min at a overall runtime of 6 min. The developed method was validated as per the requirements of ICH guidelines. Finally a comparison of the method was done against conventional HPLC. The developed method was superior with respect to analysis time, efficiency and sensitivity. The run time of Lansoprazole in conventional hplc method was about 15 min. Compare to HPLC method the developed method is cost effective and more rugged. The method can be used for routine analysis of assay in Quality Control laboratory on regular basis.