Simultaneous Estimation of Three Drugs Ambroxol, Roxithromycin and Serratiopeptidase in Pharmaceutical Dosage Forms Using High Performance Liquid Chromatography

Abstract

An accurate, simple and precise RP-HPLC method with photodiode array detector (PDA) for the simultaneous determination of ambroxol, roxithromycin and serratiopeptidase in bulk and in pharmaceutical dosage form was developed and validated. The three drugs were separated and estimated using Waters HPLC system and YMC Pack pro C18 (250 × 4.6 mm) 5 \(\mu\)m particle size column. The mobile phase consisted of 0.1% orthophosphoric acid and acetonitrile (60:40 v/v). The calibration curves were linear over concentration range of 12-36 \(\mu\)g/mL, 60-180 \(\mu\)g/mL and 6-18 \(\mu\)g/mL with limits of detection of 0.040 \(\mu\)g/mL, 1.176 \(\mu\)g/mL and 0.127 \(\mu\)g/mL for ambroxol, roxithromycin and serratiopeptidase, respectively. Recovery varied in range of 99.57% - 100.24% with relative standard deviation ranging from 0.12% to 0.36% for the current drugs. The proposed method was found to be appropriate for the quality control of ambroxol, roxithromycin and serratiopeptidase simultaneously in a bulk drug as well as in pharmaceutical dosage forms.