Abstract
Reverse Phase - High performance liquid chromatographic (RP - HPLC) method was described for determination of Ambroxol Hydrochloride (AMB) and Cefixime Trihydrate (CEF). The chromatographic separation was achieved using mobile phase mixture of Acetonitrile and 0.03 M Tetra Butyl Ammonium Hydrogen Sulphate (pH 6.5 adjusted with Sodium Hydroxide Solution) in the ratio of 25:75 (%v/v) and Zorbex Bonus C18, (250 x 4.6 mm i.d), Particle size 5 m column at 1.2 ml/min flow rate. 20 μL of standard preparation containing 150 μg/ml AMB and 500 μg/ml CEF was injected into the column and the component was separated by carrying out elution for a run time of 15 minutes and detected at 240 nm wavelength. The described method shows excellent linearity over a range of 6 to 60 μg/ml and 20 to 200 μg/ml for AMB and CEF, respectively. AMB and CEF were subjected to stress degradation conditions of hydrolysis (acid and base), oxidation and thermal degradation. Stressed samples were analysed by the developed method. The proposed method is simple, highly fast, economical, sensitive and reliable and is found to be more precise, accurate, specific, stability indicating, rugged and robust. It was readily applied for the assay of pharmaceutical formulations and the results were found to be accepted, therefore the proposed method can be adopted for the routine analysis of any quality control laboratory.
