Quantitative Estimation of Roxithromycin and Ambroxol in Bulk and Tablet Dosage Forms by RP-HPLC Method

Abstract

A Rapid and Precise Reverse Phase High Performance Liquid Chromatographic method has been developed for the validated of Roxithromycin and Ambroxol, in its pure form as well as in tablet dosage form. Chromatography was carried out on Altima C18 (4.6 x 150mm, 5µm) column using a mixture of ACN, Methanol and Phosphate buffer pH4.6 (10:25:65 v/v) as the mobile phase at a flow rate of 1.0ml/min, the detection was carried out at 215nm. The retention time of the Roxithromycin and Ambroxol was 2.344, 3.286±0.02min respectively. The method produce linear responses in the concentration range of 10-50mg/ml of Roxithromycin and 2.5-12.5mg/ml of Ambroxol. The method precision for the determination of assay was below 2.0 %RSD. The method is useful in the quality control of bulk and pharmaceutical formulations.