Abstract
Anti H.pylori therapy consists of combination of antimicrobials like amoxycillin or clarthromycin and nitroimadazoles. Eradication of H.pylori concurrently with H2 blocker /PPI therapy of peptic ulcer has been associated with faster ulcer healing and lower relapse rate. Heligo® is a fixed-dose combination tablet kit containing Combipack containing 2 capsules of Lansoprazole 30 mg, 2 tablets of Clarithromycin 250 mg & 2 tablets of Tinidazole 500 mg. It is indicated for Eradication of H.pylori infection in patients with duodenal ulcers, gastric ulcer, chronic active gastritis and gastric non-nodgkin lymphoma of MALT. Chromatographic separation of the three drugs was achieved by using a gradient elution at a flow rate of 1.0 mL/min on Inertsil ODS 3V C18 column (250m×4.6mm, 5μm particle size, 100Å pore size) at ambient temparature. Mobile phase containing 0.2% Ortho-phosphoric acid in 1000 ml of water and 4 grm of Hexane sulphonic acid adjust pH: 2.5 with dilute KOH: Methanol (30:70 v/v). UV detection at 205nm was employed to monitor the analytes. A linear response was observed in the range of 25–275 μg/ mL for Clarithromycin, 62.2–746.4 μg/ mL for Tinidazole and 8.5-102 μg/ mL Lansaprazole. Limit of detection (LOD) for Clarithromycin, Tinidazole and Lansaprazole were 12.5 μg/mL, 0.622 μg/mL, and 1.75μg/mL respectively. Limit of quantification (LOQ) for Clarithromycin, Tinidazole and Lansaprazole were 37.5 μg/mL, 1.86 μg/mL and 5.1μg/mL respectively. The present study demonstrates the applicability of chromatographic method to develop a new, sensitive and robust RP-HPLC method for the simultaneous quantitative determination of three acive pharmaceutical ingredients in fixed pharmaceutical dosage form.
