Application of HPLC for the simultaneous determination of aceclofenac, paracetamol and tramadol hydrochloride in pharmaceutical dosage form

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 (t(R)) 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.

Keywords: Aceclofenac; HPLC; Method development; Paracetamol; Tramadol hydrochloride; Validation.

Fig. 1.

Structure of Aceclofenac (ACF),Paracetamol (PCM) and Tramadol (TRM)

Fig. 2.

UV spectrum overlay of ACF, PCM and TRM

Fig. 3.

Chromatogram of sample containing 325 μg mL⁻¹ of PCM (t_R 3.133), 37.5 μg mL⁻¹ of TRM (t_R 7.858) and 100 μg mL⁻¹ of ACF (t_R 14.567)