عنوان المقالة:Development of RP-HPLC method for simultaneous estimation of gemifloxacin and ambroxol in tablet formulation Development of RP-HPLC method for simultaneous estimation of gemifloxacin and ambroxol in tablet formulation
A reverse phase high performance liquid chromatographic method was developed for the simultaneous determination of gemifloxacin and ambroxol in tablet dosage forms. Separation of both gemifloxacin and ambroxol was achieved within 7 min with required resolution, accuracy and precision thus enabling the utility of the method for routine analysis. Chromatographic separation was achieved on a BDS Hypersil C18 column (250 × 4.6 mm, 3.5μ) using a mobile phase consisting of phosphate buffer pH 5.8 and acetonitrile in the ratio of 40:60 at a flow rate of 1.2 mL per min. The detection was made at 246 nm. The retention time of gemifloxacin and ambroxol were 2.553 and 3.546 min respectively. The method was found linear over the range of 50-90 μg/mL for gemifloxacin and 11.7-21 μg/mL for ambroxol. The proposed method was validated as per the ICH guidelines.