Application of HPLC for the Simultaneous Determination of Aceclofenac, Paracetamol and Tramadol Hydrochloride in Pharmaceutical Dosage Form

Preeti Chandra

doi:10.3797/scipharm.1108-04

Abstract

A simple, precise and accurate reversed-phase liquid chromatographic method has been developed for the simultaneous estimation of aceclofenac (ACF), paracetamol (PCM) and tramadol hydrochloride (TRM) in pharmaceutical dosage form. The chromatographic separation was achieved on a HiQ-Sil™ HS C18 column (250×4.6 mm i.d., 5 μm particle size), kromatek analytical column at ambient temperature. The mobile phase consisted of 40: 60 (v/v); phosphate buffer (pH 6.0): methanol. The flow rate was set to 1.0 mL min−1 and UV detection was carried out at 270 nm. The retention time (tR) for ACF, PCM and TRM were found to be 14.567 ± 0.02, 3.133 ± 0.01 and 7.858 ± 0.02 min, respectively. The validation of the proposed method was carried out for linearity, precision, robustness, limit of detection, limit of quantitation, speci city, accuracy and system suitability. The linear dynamic ranges were from 40–160 μg mL−1 for ACF, 130–520 μg mL−1 for PCM and 15–60 μg mL−1 for TRM. The developed method can be used for routine quality control analysis of titled drugs in pharmaceutical dosage form.

Highlights

Aceclofenac (ACF) (Fig. 1), [({2-[(2,6-dichlorophenyl)amino]phenyl}acetyl)oxy]acetic acid [1], has analgesic properties and a good tolerability profile in a variety of painful conditions [2, 3]
The HPLC procedure was optimized with a view to develop a simultaneous assay method for ACF, PCM and TRM, respectively
The stock standard solution was diluted with diluent to a concentration of 100 μg mL−1 for ACF, 325 μg mL−1 for PCM and 37.5 μg mL−1 for TRM

Summary

Introduction

Aceclofenac (ACF) (Fig. 1), [({2-[(2,6-dichlorophenyl)amino]phenyl}acetyl)oxy]acetic acid [1], has analgesic properties and a good tolerability profile in a variety of painful conditions [2, 3]. From the above literature survey it is very clear that no method has been reported for simultaneous determination of ACF, PCM and TRM by HPLC. The present study is designed for the development and validation of simple, precise and accurate HPLC method for the simultaneous determination of ACF, PCM and TRM in pharmaceutical dosage form.

Results

Conclusion