DEVELOPMENT AND VALIDATION OF DIFFERENTIAL PULSE POLAROGRAPHIC ANALYSIS OF FENOFIBRATE IN PURE AND PHARMACEUTICAL DOSAGE FORMS USING DROPPING MERCURY ELECTRODE
Keywords:Differential pulse polarographic analysis, Fenofibrate, Pharmaceutical formulations
Objective: An easy, fast, accurate and sensitive differential pulse polarographic analysis for determination of fenofibrate (FEN) in pure and pharmaceutical dosage forms using dropping mercury electrode (DME) was applied.
Methods: The method involves the electrochemical reduction of fenofibrate at DME by differential pulse polarographic analysis (DPPA). Different buffer solutions were used over a wide pH range (1.0â€“10.0). The best definition of the analytical signals was found in lithium perchlorate trihydrate buffer at pH 6.0 containing 24% (v/v) acetonitrile at-994 to-1025mV (versus Ag/AgCl).
Results: Under optimized conditions the peak current (Ip) is linear over the range 0.0361-3.608 Î¼g/ml. The DPPA was used successfully for the determination of FEN in pure and pharmaceutical dosage forms. The relative standard deviation did not exceed 2.1% for the concentration of FEN 0.0361 Î¼g/ml. Regression analysis showed a good correlation coefficient (R2= 0.9994) between Ip and concentration at the mentioned range. The limit of detection (LOD) and the limit of quantification (LOQ) was to be 0.0025 and 0.0076 Î¼g/ml, respectively. The proposed method was validated for linearity, precision and accuracy, repeatability, sensitivity (LOD and LOQ), robustness and specificity with an average recovery of 99.8-100.6%.
Conclusion: The developed method is applicable for the determination of FEN in pure and different dosage forms with the assay of marketed formulations 99.8-104.0% and the results are in good agreement with those obtained by square-wave voltammetry (SWV) reference method.
Keywords: Differential pulse polarographic analysis, Fenofibrate, Pharmaceutical formulations
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