DEVELOPMENT AND VALIDATION OF DIFFERENTIAL PULSE POLAROGRAPHIC ANALYSIS OF FENOFIBRATE IN PURE AND PHARMACEUTICAL DOSAGE FORMS USING DROPPING MERCURY ELECTRODE

Authors

  • Abdul Aziz Ramadan Department of Chemistry, Faculty of Science, University of Aleppo, Syria
  • Hasna Mandil Department of Chemistry, Faculty of Science, University of Aleppo, Syria
  • Reham Abu-saleh Department of Chemistry, Faculty of Science, University of Aleppo, Syria

DOI:

https://doi.org/10.22159/ijpps.2016v8i10.12762

Keywords:

Differential pulse polarographic analysis, Fenofibrate, Pharmaceutical formulations

Abstract

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 (1.0–10.0). 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 μg/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 μg/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 μg/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

Downloads

Download data is not yet available.

References

- Martindale: The Extra Pharmacopoeia, The Complete Drug Reference (1999) 32nd Ed., K. Porfitt (Ed.), Royal Pharmaceutical Society, London, UK.

- Neil Maryadele JO, Merck Index. 2006;14:1743.

- Yardımcı C, Ozaltın N, Electrochemical studies and square-wave voltammetric determination of fenofibrate in pharmaceutical formulations. Anal Bional Chem 2004; 378:495-8.

- Sahoo DK, Sahu PK, Patro CS. New validated isocratic RP-HPLC method for assay of fenofibrate. Int J Pharm Pharm Sci 2014;6(2):169-72.

- Mohamed A. Korany, Ismail I. Hewala, Karim M. Abdel-Hay, Determination of etofibrate, fenofibrate, and atorvastatin in pharmaceutical preparations and plasma using differential pulse polarographic and squarewave voltammetric techniques. J AOAC Int 2008; 91(5): 1051-8.

- Suresh Kumar GV, Rajendra Prasad Y. Development and Validation of Reversed-Phase HPLC Method for Simultaneous Estimation of Fenofibrate and Fenofibrate in Tablet Dosage Form. International Journal of PharmTech Research 2010; 2(3): 2016-21.

- Rupali H, Ravindra B, Manish K. RP-HPLC method for simultaneous estimation of atorvastatin calcium and fenofibrate in tablet dosage forms. journal of pharmacy research 2010; 3(10): 2400-01.

- Choudhari VP, Nikalje AP. Simultaneous Estimation of Atorvastatin, Ezetimibe and Fenofibrate in Pharmaceutical Formulation by RP-LC-PDA. Pharm Anal Acta. 2010; 1: 111.

- Krishna RG, Sonali SA, Prashant RR and Sudhir GW. Validated spectrophotometric determination of fenofibrate in formulation. Der Pharmacia Sinica 2010; 1(1): 173-178.

- Sevda RR, Ravetkar AS, Shirote PJ. UV Spectrophotometric estimation of fenofibrate calcium and fenofibrate in bulk drug and dosage form using simultaneous equation method. Int J Chem Tech Res 2011;3(2):629-35.

- Dhabale PN, Gharge DS. Simultaneous spectrophotometric estimation of atorvastatin and fenofibrate in bulk drug and dosage form by using simultaneous equation method. Int J Chem Tech Res 2010;2(1):325-8.

- ICH: Proceedings of the International Conference on Harmonization of Technical Requirement of Registration of Pharmaceuticals for Human Use (ICH Harmonized Tripartite Guidelines).

Published

2016-10-01

How to Cite

Ramadan, A. A., H. Mandil, and R. Abu-saleh. “DEVELOPMENT AND VALIDATION OF DIFFERENTIAL PULSE POLAROGRAPHIC ANALYSIS OF FENOFIBRATE IN PURE AND PHARMACEUTICAL DOSAGE FORMS USING DROPPING MERCURY ELECTRODE”. International Journal of Pharmacy and Pharmaceutical Sciences, vol. 8, no. 10, Oct. 2016, pp. 284-9, doi:10.22159/ijpps.2016v8i10.12762.

Issue

Section

Original Article(s)