Abstract
DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF LEVOFLOXACIN HEMIHYDRATE AND AMBROXOL HYDROCHLORIDE IN THE PHARMACEUTICAL DOSAGE FORM
D. Sireesha,* Dr K Raj Narayana, M.Ajitha and Vasudha Bakshi
ABSTRACT
A new simple, rapid, specific, accurate and precise Reverse Phase High Performance Liquid Chromatography (RP-HPLC) method has been developed for the simultaneous estimation of Levofloxacin hemihydrate and Ambroxol hydrochloride in the combined pharmaceutical dosage form. The chromatographic separation for Levofloxacin hemihydrate and Ambroxol hydrochloride was achieved with mobile phase containing 0.1% Triethyl amine (pH adjusted to 5 with Orthophosphoric acid) and Acetonitrile (50:50 % v/v), Universil C18 column (150 × 4.6mm i.d, particle size of 5?) at room temperature and UV detection at 250 nm. The compounds were eluted in the isocratic mode at a flow rate of 0.6ml/min. The retention times of Levofloxacin hemihydrate was at 4.8±0.059 min and Ambroxol hydrochloride was at 5.7±0.090 min. The above method was validated in terms of linearity, accuracy, precision, LOD, LOQ in accordance with ICH guideline.
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