A Validated Ultra Performance Liquid Chromatography Method for Simultaneous Estimation of Diacerein and Aceclofenac in Bulk and Pharmaceutical Formulation

Abstract

A simple, exceptionally cost-effective, extremely accurate, quite precise and highly reproducible analytical method was developed and validated for simultaneous estimation of Diacerein and Aceclofenac in bulk and Pharmaceutical formulation. The new Ultra Performance Liquid Chromatography technique was developed. Method- The separation has been done on column ACQUITY UPLC BEH Shield C18 (50 x 2.1mm), 1.7µm (40°C temperature). The mobile phase contained Buffer and Acetonitrile (Buffer: ACN) (55:45 V/V).. The flow rate was set at 0.4ml/min, and detected at 268nm with PDA detector. Mobile phase was sonicated for 15 min. before use. 5μl of samples of standard stock solution and tablet solution were injected. Different trials were performed to separate diacerein and aceclofenac. The total run time of the detection was 4 min. The developed method was validated against different validation parameters. Results - The retention times were obtained at 1.762min. and 2.891 min. for Diacerein and Aceclofenac respectively. Accuracy study was observed in the range of 100.33% to 101.67% with less than 2% RSD. LOQ was found to be 2.98μg/ml and 5.9041μg/ml. similarly LOD was found to be 0.9841μg/ml and 1.9467μg/ml. for Diacerein and Aceclofenac respectively. Precision %RSD for intraday and interday were found to be 0.19 and 0.18 for Diacerein , 0.44 and 0.16 for Aceclofenac respectively. Linearity was found in the range of 2.5-17.5μg/ml and 5-35μg/ml for Diacerein and Aceclofenac respectively. The method was found robust by deliberate changes in the flow rate, ratio of mobile phase and detection wavelength. Conclusion-The method was found to be satisfactory and can be used successfully for determination of Diacerein and Aceclofenac simultaneously in bulk and pharmaceutical dosage form.