Development and Validation of A Stability-Indicating Reversed Phase HPLC Method for Determination of Moxifloxacin in Bulk and Pharmaceutical Dosage Form

摘要

The present study describes a novel stability indicating Reversed Phase High-Performance LC method for the determination of Moxifloxacin (MOXI) in bulk and pharmaceutical formulation. The chromatographic separation was carried out on Agilent technologies model SPD 20A prominence UV detector, utilizing Kromasil model C18 Column (based on 99.999 % ultra high purity silica) 150 mm × 4.6 mm, 3.5 μm particle size, utilizing methanol: phosphate buffer pH 2.5, (60:40 % v/v) as mobile phase at flow rate of 1.2 ml/minute with an injection volume of 20 μl was selected for this study. The separation was carried out at a room temperature and the eluents were observed by photo diode array detector set at 292 nm. The retention time of MOXI obtained was at 5.495 minutes. The calibration curve for MOXI was linear (r2 = 0.9999) over the concentration range of 6-18 μg/ml with LOD and LOQ of 0.001 μg/ml and 0.003 μg/ml respectively. A recovery of MOXI in tablet formulation was observed in the range of 99.68- 99.90 %. Percentage assay of MOXI tablets (Avelox) and bulk drug was found to be 99.95 ± 2.92 and 99.97 ± 3.05 respectively. The stability of the method was demonstrated by forced degradation studies under conditions of acidic, alkaline, oxidation, photolytic, thermal and UV stress conditions as per ICH Q1A (R2) guidelines. Thus the proposed method for MOXI was found to be feasible for the estimation of MOXI in bulk as well as pharmaceutical dosage form.