High Performance Liquid Chromatographic Determination of Ambroxol, Roxithromycin and Serratiopeptidase in Combined Tablet Dosage Form

摘要

A simple, sensitive and accurate RP-HPLC method for the simultaneous quantification of ambroxol, roxithromycin and serratiopeptidase in bulk and in combined tablet dosage form was developed and validated. Ambroxol, roxithromycin and serratiopeptidase were separated and estimated using Waters HPLC system and YMC Pack pro C18 (250 mm x 4.6 mm, 5 μm particle size) column. The mobile phase used was 0.1 % orthophosphoric acid and acetonitrile in the ratio of 60:40 (v/v). The calibration curves were linear over concentration range of 12-36,60-180 and 6-18 μg/mL with limits of detection of 0.040,1.176 and 0.127 μg/mL for ambroxol, roxithromycin and serratiopeptidase, respectively. For the studied drugs, recovery varied in range of 99.57 to 100.24 % with relative standard deviation ranging from 0.12 to 0.36 %. The proposed RP-HPLC method could be used for the analysis of ambroxol, roxithromycin and serratiopeptidase simultaneously in combined tablet dosage forms.