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Development and Validation of Novel HPLC Method for Simultaneous Estimation of Gemifloxacin Mesylate and Ambroxol Hydrochloride in Combined Tablet Dosage Form

T. Raja, A. Lakshmana Rao and G. Sadasiva Rao

A high performance liquid chromatographic (HPLC) method was developed and validated for the simultaneous determination of gemifloxacin mesylate (GEM) and ambroxol hydrochloride (AMB) in combined tablet dosage form by external standard method. The analysis was carried out using acetonitrile, methanol, 0.1% trifluoroacetic acid in the ratio of 20 : 20 : 60% v/v (pH was adjusted to 3.5 with orthophosphoric acid) as a mobile phase on Zorbax SB C3 (150 mm × 4.6 mm i.d., 5 μm particle size) pre-packed column, at a flow rate of 1.0 mL/min with UV detection of 252 nm. Retention time was found to be 5.08 min and 3.84 min for GEM and AMB respectively. The method was validated for linearity, accuracy, precision and specificity. The method showed good linearity in the range of 4-426 μg/mL and 1-100 μg/mL for GEM and AMB. The detection limit and quantification limits for GEM and AMB was 0.08 & 0.19 μg/mL and 0.19 & 0.60 μg/mL respectively. The % recovery was within the range between 98.75% and 101.16% for GEM and % recovery was within the range between 99.09% and 101.23% for AMB. The % RSD for precision and accuracy of the method was found to be less than 2. The method was validated as per the ICH guidelines. The method was successfully applied for routine analysis of GEM and AMB in combined dosage form.