Paper Contents
Abstract
The development and validation of a Reverse-Phase High-Performance Liquid Chromatography (RP-HPLC) method for the simultaneous estimation of tramadol and aceclofenac in combined tablet dosage forms are presented. This method addresses the need for a reliable and efficient analytical technique to quantify both drugs in a single run. The RP-HPLC analysis was conducted using a Waters HPLC system equipped with an auto sampler and a PDA Detector 996 model. The chromatographic separation was achieved using a Symmetry ODS C18 column (4.6 mm 150 mm, 5 m particle size) with a mobile phase consisting of methanol and water in a 40:60 (vv) ratio. The flow rate was set at 1 mLmin, and the detection was performed at a wavelength of 240 nm. The injection volume was 10 L, and the total run time for each analysis was 7 minutes.The method was meticulously validated according to ICH guidelines, evaluating parameters such as specificity, linearity, precision, accuracy, and robustness. The developed RP-HPLC method demonstrated excellent resolution and peak symmetry for both tramadol and aceclofenac, with a high degree of accuracy and precision. This method provides a reliable tool for the simultaneous quantification of tramadol and aceclofenac in combined tablet formulations, ensuring quality control and compliance with pharmaceutical standards.
Copyright
Copyright © 2024 SANGEETHA. This is an open access article distributed under the Creative Commons Attribution License.
