Simple RP-HPLC method for Aceclofenac quantitative analysis in pharmaceutical tablets

Abstract

A reverse phase liquid chromatographic method for estimation of Aceclofenac in bulk drug and tablet dosage form was developed and validated. The chromatographic conditions to achieve the highest performance parameters using octylsilyl column with guard filter were optimized. The separation was carried out using a mobile phase containing 10 mM Phosphate Buffer, pH 2.1 and methanol (30:70% v/v) pumped at a flow rate of 1.0 mL/min with detection at 272 nm. The method was shown to be linear in 19.8–148.5 μg/mL concentration range (regression coefficient of 0.999). The limit of detection (LOD) and limit of quantification (LOQ) was found to be 0.0692 μg/mL and 0.2076 μg/mL, respectively. The accuracy of the method was assessed by adding fixed amount of pre-analyzed sample to different standard solutions (80%, 100%, and 120% of the tested concentration) in triplicate. The percentage mean recoveries were 97.91% to 100.39% with %RSD values of 0.64–0.79. The method was found to be precise with %RSD value of 1.13 and 1.60 for intraday and interday precision study, respectively. The method specificity and robustness were also established. New and sensitive HPLC method for estimation of Aceclofenac has been developed, in respect to the reviewed analytical methods.