A Validated Stability-Indicating Method for the Estimation of Aceclofenac in Pharmaceutical Dosage Form by RP-HPLC

[摘要] The aim of the research study was the development and validation of a simple, rapid, accurate and precise reversed-phase high performance liquid chromatography (RP-HPLC) stability-indicating method for the determination of aceclofenac in bulk and pharmaceutical dosage forms. The RPHPLC studies was performed on the instrument Jasco HPLC system with Jasco UV 2010 photo diode array detector, ODS C18 RP-column (Intersile 250 mm × 4.6 mm; i.d. 10 μm), Rheodyne injection syringe with 20µL loop volume and windows based chrompass software was used for separation. The isocratic elution was performed using the mobile phase ratio of methanol: water (65:35 v/v) and UV detection wavelength at 263 nm. The overall run time of the analysis was 20 minutes and the flow rate was 1.0 mL/min. The RP-HPLC method developed for analysis of aceclofenac was validated as per the ICH guidelines with respect to specificity, selectivity, linearity, accuracy, precision and robustness. The linearity for developed method was observed in the concentration range of 5-50 μg/mL with the correlation coefficient (r 2 ) of 0.9992. The percentage accuracy of aceclofenac ranged from 99.40 to 100.79%. The relative standard deviation for inter-day precision was lower than 2.0%. The assay of aceclofenac was determined in tablet dosage form was found to be within limits. Aceclofenac was subjected to stress conditions such as neutral, acidic, alkaline, oxidation, and photolysis degradations as per ICH guidelines. The results of degradation studies revealed that the drug degraded a maximum (32.68%) in acidic conditions followed by alkaline conditions (15.05%). The drug was found to be resistant towards neutral, acidic and photolytic degradation conditions.

[学科分类] 药学

[关键词] Aceclofenac;RP-HPLC;Validation;Stability-indicating studies;ICH guidelines .