Reversed-Phase High-Performance Liquid Chromatographic and Mass Spectrophotometric Methods for Simultaneous Determination of Paracetamol, Aceclofenac and Tramadol in Combined Tablet Dosage Form in Presence of its Degradation Products

Simple, accurate, precise, and sensitive reversed-phase high-performance liquid chromatographic (RP-HPLC) method for simultaneous estimation of Paracetamol (PCM), Tramadol and Aceclofenac in the presence of its degradation products, have been developed and validated by LC/MS. Linearity of PCM, TRA and ACL was obeyed in concentration range 2–30, 2–14 and 2–35 μg/ml in Acetonitrile: Phosphate buffer (pH 3.4, 20:80 v/v) as the mobile phase at 270 nm, respectively. The detection was carried out using a diode array detector set at 270 nm. Linearity of the LC method was in the concentration range of 2–10 μg/mL for PCM, TRA and ACL respectively. The recoveries were in the range of 99.49 ± 0.74 to 100.08 ± 0.1 for PCM, 99.36 ± 0.73 to 100.05 ± 0.10 for TRA and 98.42 ± 0.96 to 101.04 ± 0.49 for ACL in RP-HPLC. RP-HPLC method has been successfully applied for the analysis of the drugs in a pharmaceutical formulation in the presence of its degradation products. Results of analysis were validated statistically. Degradation study was performed under different conditions using same RP-HPLC method and method was revalidated for simultaneous estimation in presence of their degradation products and confirmed by LC/MS.