Simultaneous Determination of Paracetamol and Diclofenac Potassium in Pharmaceutical Preparation by using High Performance Liquid Chromatography Antakli Saad*, Nejem Leon, Shawa Duha Department of Chemistry, Faculty of Science, University of Aleppo, Syria *Corresponding Author E-mail: antakli@scs-net.org
Online published on 31 October, 2018. Abstract An accurate, simple, reproducible and sensitive method for the determination of Paracetamol (Par) and Diclofenac potassium (Dic.p) in pharmaceutical formulations was developed and validated. (Par) and (Dic.p) were separated by using an isocratic mobile phase of acetonitrile:phosphoric acid (pH=2.43) in ratio of 60:40 (v/v) on a Shim-pack clc-C8 column (25 cm x 4.6 mm i.d., 5 μm), with UV detection at 274 nm, pump flow rate was 1.0 mL/min and sample injection volume 20 μL. Under these conditions, separation of each two components was achieved in less than 8 min with a good resolution, whereas the retention times of (Par) and (Dic.p) were found to be 3.03 min and 6.68 min respectively. The proposed method was validated for linearity, accuracy, and precision, limit of detection and limit of quantification. The linear range of determination for (Par) and (Dic.p) in presence of Sodium propyl paraben (PP.Na) as internal standard were (2.5–500) μg/mL and (1–250) μg/mL respectively. The limit of detection (LOD) and limit of quantification (LOQ) were to be 0.48 μg/mL and 1.47 μg/mL for (Par), 0.26 μg/mL and 0.80 μg/mL for (Dic.p), respectively. The proposed method was successfully applied to analysis individual or mixture of (Par) and (Dic.p) in Syrian trademark drugs. All studied samples showed that the drug levels were conformed to united state pharmacopeia (USP) legislation. Finally, the developed method is simple, quick and suitable for routine quality control analysis of titled drugs in combination of tablet formulations. Top Keywords HPLC, paracetamol, diclofenac potassium. Top |