STABILITY INDICATING RP-HPLC METHOD FOR COMBINATION OF AMBROXOL HYDROCHLORIDE AND LEVOFLOXACIN HEMIHYDRATE IN PHARMACEUTICAL FORMULATION

Ambroxol hydrochloride (AMB) and Levofloxacin hemihydrate (LVF) in combination were separated using Reverse-Phase – High-Performance Liquid Chromatographic (RP-HPLC) method. Mobile phase acetonitrile and 0.05 M potassium di-hydrogen orthophosphate buffer (pH 7.0 adjusted with sodium hydroxide solution) (50: 50, v/v) was selected for this chromatographic method. The separation was achieved in Zorbax Eclipse XDB -C18 column with (250 × 4.5 mm i.d), 5mm particle size with a flow rate of 1.0 ml/min. At 248 nm wavelength, 10 µl of 60 µg/ml Ambroxol hydrochloride and 400 µg/ml Levofloxacin hemihydrate (LVF) was injected for 15 min runtime, and an individual peak was obtained for LVF at retention time 2.61 min and for AMB at retention time 7.69 min. Linearity was achieved for Ambroxol hydrochloride in the range of 48 mcg/ml to 72 mcg/ml and Levofloxacin hemihydrate in the range of 320 mcg/ml to 480 mcg/ml. For stress degradation, AMB and LVF were subjected to acid hydrolysis, base hydrolysis, thermal degradation, UV light degradation, oxidation and analyzed with this chromatographic method. The results obtained with this method are useful for assay of this pharmaceutical formulation; hence this method can be used in the pharmaceutical industry.