A validated RP – HPLC method for simultaneous estimation of diacerine and aceclofenac in tablet dosage form


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2

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2

Abstract :

A simple, rapid reverse-phase high performance liquid chromatographic method has been developed and validated for the simultaneous estimation of Diacerine and Aceclofenacin in tablet dosage form. The estimation was carried out on a Phenomenax Luna C18 (150mmx 4.6 mm i.d, particle size 5 mcm ) column with a mixture of acetonitrile: methanol: buffer( potassium dihydrogen ortho phosphate PH 3.0) in the ratio of35:20:45 (v/v ) as mobile phase. UV detection was performed at 270nm. The flow rate was 2ml/min The method was validated for linearity, accuracy, precision, specificity and sensitivity as per ICH norms. The retention time was 6.3and 3.6 minute for Diacerine and Aceclofenac respectively. The flow rate was 2.0ml/min. The calibration curve was linear over the concentration range of 80-120mcg /ml for Diacerine and 160-240mcg /ml for Aceclofenac. The LOD and LOQ values were found to be 0.490 and 1.485 mcg/ml for Diacerine and 5.129and 15.542mcg/ml for Aceclofenac respectively. The developed and validated method was successfully used for the quantitative analysis of commercially available dosage form. The developed method has required accuracy and precision for routine analysis of Diacerine and Aceclofenac in tablet dosage form.
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