Stability Indicating HPLC Method for Drugs Indicated for Helicobacter Pylori-associated Ulcers

Abstract

Triple therapy regimen that comprises a proton pump inhibitor likes Omeprazole, antibiotics like Doxycycline and Tinidazole can be used for treatment of peptic ulceration which is caused by H. pylori. A validated HPLC method was developed as a stability-indicating HPLC method for these drugs and its impurities. New method overcame interference between Doxycycline and its epimer on achiral column by using a chiral mobile phase. The method was performed on Phenomenex BDS HYPERSIL C18 5 μm 100A (250x4.6 mm) and the mobile phase consisted of (1S)-(+)-Campher-10-sulfonic acid (0.01M) and Edetate disodium (0.001M) (pH=4.5) Acetonitrile which pumped at a flow rate 1.2 ml/min in gradient manner at 40°C. 20 µl of drugs sample solutions were monitored at wavelength 310 nm. Tinidazole, Doxycycline and Omeprazole and Trio capsule bulk powders were stressed under different conditions in forced degradation studies. Method validation was developed following the recommendations for analytical method validation of International Conference on Harmonization (ICH) and Food and Drug Administration (FDA) organizations.

Keywords: Tinidazole, Doxycycline, Omeprazole, chiral mobile phase, stability indicating assay-ulcer treatment