Abstrakt

A validated stability indicating RP-LC method for determination of moxifloxacin in bulk powder and in pharmaceutical formulations

Mamdouh R.Rezk, Iman A.Abdel-Karim

A simple stability indicating HPLC method was developed and validated for determination of moxifloxacin hydrochloride in the presence of its induced degradation products. The drug was subjected to stress stability studies including acidic, alkaline and oxidative stress conditions, and the stressed samples were analyzed by the proposed method. The developed method utilized Symmetry C18 column (250 × 4.6 mm, 5 ìm) in an isocratic separation mode. The mobile phase consisted of methanol: 0.2 % triethylamine (pH 2.5 with orthophosphoric acid), (35: 65, v/v) at a flow rate 1.5 mL/min with UV-detection at 290 nm. The proposedmethod was validated according to the International Conference on Harmonization (ICH) guidelines. The method was applied for determination of moxifloxacin hydrochloride in pure powder and in its pharmaceutical formulations.