Author(s): elSaharty YS, Refaat M, elKhateeb SZ, elSaharty YS, Refaat M, elKhateeb SZ
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Abstract Three methods were developed for the determination of aceclofenac in the presence of its degradation product, diclofenac. In the first method, third-derivative spectrophotometry (D3) is used. The D3 absorbance is measured at 283 nm where its hydrolytic degradation product diclofenac does not interfere. The suggested method shows a linear relationship in the range of 4-24 micrograms mL-1 with mean percentage accuracy of 100.05 +/- 0.88. This method determines the intact drug in the presence of up to 70\% degradation product with mean percentage recovery of 100.42 +/- 0.94. The second method depends on ratio-spectra first-derivative (RSD1) spectrophotometry at 252 nm for aceclofenac and at 248 nm for determination of degradation product over concentration ranges of 4-32 micrograms mL-1 for both aceclofenac and diclofenac with mean percentage accuracy of 99.81 +/- 0.84 and 100.19 +/- 0.72 for pure drugs and 100.17 +/- 0.94 and 99.73 +/- 0.74 for laboratory-prepared mixtures, respectively. The third method depends on the quantitative evaluation of thin-layer chromatography of aceclofenac using chloroform:methanol: ammonia (48:11.5:0.5 v/v/v) as a mobile phase. Chromatograms were scanned at 274 and 283 nm for aceclofenac and diclofenac, respectively. The method determined aceclofenac and diclofenac in concentration ranges of 2-10 and 1-9 micrograms spot-1 with mean percentage accuracy of 100.20 +/- 1.03 and 100.14 +/- 0.98 for pure drugs and 99.77 +/- 0.74 and 100.07 +/- 0.78 for laboratory-prepared mixtures, respectively. This method retains its accuracy in the presence of up to 80\% degradation product for the studied drug. The suggested procedures were checked using laboratory-prepared mixtures and were successfully applied for the analysis of their pharmaceutical preparation. The validity of the proposed methods was further assessed by applying a standard addition technique. The obtained results agreed statistically with those obtained by the reported method.
This article was published in Drug Dev Ind Pharm
and referenced in Journal of Chromatography & Separation Techniques