A novel, precise, accurate and rapid isocratic reversed-phase high performance liquid chromatographic/ultraviolet (RP-HPLC/UV) method was developed, optimized and validated for simultaneous determination of Tramadol HCl and Aceclofenac. The method showed adequate separation for Tramadol HCl and Aceclofenac and best resolution was achieved with Phemnomenex C18 column (250 mm x 4.6 mm i.d., 5 µm particle size) using Water: Acetonitrile: Triethylamine [50:50:0.5, v/v/v] pH adjusted to 6 with o-phosphoric acid as a mobile phase at a flow rate of 1 ml/min and wavelength of 271 nm. The calibration curves were linear over the concentration ranges of 3.75-22.5 μg/ml and 10-60 for Tramadol HCl and Aceclofenac respectively. The limit of detection (LOD) and limit of quantification (LOQ) for Tramadol HCl were 0.240 and 0.729 μg/ml while for Aceclofenac were 0.661 and 2.004 μg/ml, respectively. All the analytes were separated in less than 7.0 min. The proposed method could be applied for routine laboratory analysis of Tramadol HCl and Aceclofenac in pharmaceutical dosage form. Methods were validated statistically and recovery studies were carried out. The proposed methods have been applied successfully to the analysis of cited drug either in pure form or in synthetic mixture of both drugs with good accuracy and precision. The method herein described can be employed for quality control and routine analysis of drugs in pharmaceutical formulations.
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