Quantitative Determination of Levofloxacin and Ambroxol Hydrochloride in Pharmaceutical Dosage Form by Reversed-Phase High Performance Liquid Chromatography

Abstract

The objective of this present work was to develop and validate analytical method for quantitative determination of Levofloxacin and Ambroxol hydrochloride in a new tablet formulation. Chromatographic separation of the two drugs were analyzed on a Hypersil BDS C18 column (25cm X 4.6mm, 5µm). The mobile phase constituted of Buffer: Acetonitirile: Methanol (650:250:100) with triethylamine and pH adjusted to 5.2 with dilute orthophosphoric acid was delivered at the flow rate 1.0 mL min-1. Detection was performed at 220 nm. Separation was completed within 10 min. Calibration curves were linear with coefficient correlation between 0.99 to 1.0 over a concentration range of 7 to 22 µg mL-1 of Levofloxacin and 50 to 150 µg/mL for Ambroxol hydrochloride respectively. The relative standard deviation (R.S.D) was found <2.0%.