Journal : Acta Chromatographica
Article : Stability-indicating RP-HPLC method for analysis of eplerenone in the bulk drug and in a pharmaceutical dosage form

Authors :
Daszykowski, M.
Silesian University Department of Chemometrics, Institute of Chemistry 9 Szkolna Street 40-006 Katowice Poland,
Sajewicz, M.
Silesian University Department of General Chemistry and Chromatography 9 Szkolna Street 40-006 Katowice Poland,
Rzepa, J.
Silesian University Department of General Chemistry and Chromatography 9 Szkolna Street 40-006 Katowice Poland,
Hajnos, M.
Medical University of Lublin Department of Pharmacognosy 1 Chodźki Street 20-093 Lublin Poland,
Staszek, D.
Silesian University Department of General Chemistry and Chromatography 9 Szkolna Street 40-006 Katowice Poland,
Wojtal, Ł.
Silesian University Department of General Chemistry and Chromatography 9 Szkolna Street 40-006 Katowice Poland,
Kowalska, T.
Silesian University Department of General Chemistry and Chromatography 9 Szkolna Street 40-006 Katowice Poland,
Waksmundzka-Hajnos, M.
Medical University of Lublin Department of Inorganic Chemistry 6 Staszica Street 20-081 Lublin Poland,
Walczak, B.
Silesian University Department of Chemometrics, Institute of Chemistry 9 Szkolna Street 40-006 Katowice Poland, beata@us.edu.pl,
Skalicka-Woźniak, K.
Medical University of Lublin Department of Pharmacognosy with Medicinal Plant Laboratory 1 Chodzki Str. 20-093 Lublin Poland,
Markowski, W.
Medical University of Lublin Department of Physical Chemistry Staszica 6 20-081 Lublin Poland,
Świeboda, R.
Medical University of Lublin Department of Inorganic and Analytical Chemistry Staszica 6 20-081 Lublin Poland,
Głowniak, K.
Medical University of Lublin Department of Pharmacognosy with Medicinal Plant Laboratory 1 Chodzki Str. 20-093 Lublin Poland,
Sultana, N.
University of Karachi Research Institute of Pharmaceutical Sciences, Department of Pharmaceutical Chemistry, Faculty of Pharmacy Karachi 75270 Pakistan,
Arayne, M. S.
University of Karachi Department of Chemistry Karachi 75270 Pakistan,
Naveed, S.
University of Karachi Research Institute of Pharmaceutical Sciences, Department of Pharmaceutical Chemistry, Faculty of Pharmacy Karachi 75270 Pakistan,
Shamshad, H.
University of Karachi Research Institute of Pharmaceutical Sciences, Department of Pharmaceutical Chemistry, Faculty of Pharmacy Karachi 75270 Pakistan,
Li, X.
China Agricultural University Department of Applied Chemistry, College of Science Beijing 100193 China,
Xu, J.
China Agricultural University Department of Applied Chemistry, College of Science Beijing 100193 China,
Jiang, Y.
China Agricultural University Department of Applied Chemistry, College of Science Beijing 100193 China,
Chen, L.
China Agricultural University Department of Applied Chemistry, College of Science Beijing 100193 China,
Xu, Y.
China Agricultural University Department of Applied Chemistry, College of Science Beijing 100193 China,
Pan, C.
China Agricultural University Department of Applied Chemistry, College of Science Beijing 100193 China,
Sheikhloie, H.
slamic Azad University, Science and Research Branch Department of Chemistry, Faculty of Science Poonak-Hesarak, Tehran Iran,
Saber-Tehrani, M.
slamic Azad University, Science and Research Branch Department of Chemistry, Faculty of Science Poonak-Hesarak, Tehran Iran,
Abrumand-Azar, P.
slamic Azad University, Science and Research Branch Department of Chemistry, Faculty of Science Poonak-Hesarak, Tehran Iran,
Waqif-Husain, S.
slamic Azad University, Science and Research Branch Department of Chemistry, Faculty of Science Poonak-Hesarak, Tehran Iran,
Mincea, M.
West University of Timişoara Faculty of Chemistry-Biology-Geography, Department of Chemistry Pestalozzi Street, 16 Timişoara 300115 Romania,
Lupşa, I.
Institute of Public Health Timişoara Department of Food Hygiene V. Babeş 16-18 Timişoara 300226 Romania,
Talpoş, I.
West University of Timişoara Multidisciplinary Research Platform “Nicholas Georgescu-Roegen” Oituz 4 Timişoara Romania,
Ostafe, V.
West University of Timişoara Faculty of Chemistry-Biology-Geography, Department of Chemistry Pestalozzi Street, 16 Timişoara 300115 Romania, vostafe@cbg.uvt.ro,
Milenović, D. M.
Zdravlje-Actavis Company, R&D Analytical Department 16000 Leskovac Serbia, dmilenovic@actavis.rs,
Todorović, Z. B.
University of Niš Faculty of Technology 16000 Leskovac Serbia,
Rane, V. P.
Dr Babasaheb Ambedkar Marathwada University Department of Chemical Technology Aurangabad 431004 (MS) India,
Patil, K. R.
Dr Babasaheb Ambedkar Marathwada University Department of Chemical Technology Aurangabad 431004 (MS) India,
Sangshetti, J. N.
Wockhardt Research Centre Aurangabad 431210 (MS) India,
Yeole, R. D.
Wockhardt Research Centre Aurangabad 431210 (MS) India,
Shinde, D. B.
Dr Babasaheb Ambedkar Marathwada University Department of Chemical Technology Aurangabad 431004 (MS) India,
Abstract : A novel stability-indicating reversed-phase (RP) HPLC method has been developed and validated for quantitative analysis of eplerenone in the bulk drug and in a pharmaceutical dosage form. Use of a 250 mm × 4.6 mm, 5-μm particle, C18 column with 55:45 ( v/v ) 50 mM ammonium acetate buffer (pH 7)-acetonitrile as isocratic mobile phase enabled separation of the drug from its degradation products. UV detection was performed at 240 nm. The method was validated for linearity, accuracy (recovery), precision, specificity, and robustness. The linearity of the method was excellent over the range 10–100 μg mL-1(correlation coefficient 0.999). The limits of detection and quantification were 0.019 and 0.053 μg mL-1, respectively. Recovery of eplerenone from the pharmaceutical dosage form ranged from 100.97 to 101.25%. Eplerenone was subjected to stress conditions (hydrolysis (acid, base), oxidation, photolysis, and thermal degradation) and the stressed samples were analysed by use of the method. Degradation was observed in acid, base, and 30% H 2 O 2 . The drug was stable under the other stress conditions investigated. The degradation products were well resolved from main peak. The forced degradation studies prove the stability indicating power of the method.

Keywords : eplerenone, dosage form, RP-HPLC, forced degradation, method validation,
Publishing house : University of Silesia in Katowice
Publication date : 2009
Number : Vol. 21, no. 4
Page : 619 – 629

Bibliography
: 1 J.A. Spertus, J. Tooley, P. Jones, C. Poston, E. Mahoney, P. Deedwania, S. Hurley, B. Pitt, and W.S. Weintraub, Am. Heart J., 143 , 636 (2002)
2 E.G. McMahon, Curr. Opin. Pharmacol., 1 , 190 (2001)
3 J.A. Delyani, R. Rocha, C.S. Cook, D.S. Tolbert, S. Levin, B. Roniker, D.L. Workman, Y.L. Sing, and B. Whelihan, Cardiovasc. Drug Rev., 19 , 185 (2001)
4 C.T. Stier, P.N. Chander Jr, and R. Rocha, Cardiology Rev., 10 , 97 (2002)
5 J. Staessen, P. Lijnen, R. Fagard, L. Verschuren, and A. Amery, J. Endocrinol., 91 , 457 (1981)
6 R.J. MacFadyen, C.S. Barr, and A.D. Struthers, Cardiovasc. Res, 35 , 30 (1997)
7 International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, Stability testing of New Drug Substances and Products. QIA (R2), August, 2003
8 J.Y. Zhang, D.M. Fast, and A.P. Breau, J. Pharm. Biomed. Anal., 31 , 103–115 (2003)
9 J.Y. Zhang, D.M. Fast, and A.P. Breau, J. Chromatogr. B, 787 , 333–344 (2003)
10 F. Varin, T. Minh, F. Benoit, J.P. Villeneuve, and Y. Theoret, J. Chromatogr., 574 , 57 (1992)
11 A.M. Kaukonen, P. Vuorela, H. Vuorela, and J.P. Mannermaa, J. Chromatogr., 797 , 271 (1998)
12 A. Jankowski, A. Skorek-Jankowaska, and H. Lamparezyk, J. Pharm. Biomed. Anal., 14 , 1359 (1996)
13 Drug Information Branch (HFD-210), Validation of analytical procedure: Methodology. Step 4. In: ICH Harmonized Tripartite Guidelines Q2B. Center for Drug Evaluation and Research, Rockville, MD, November, 6 (1996)
14 M. Bakshi, B. Singh, A. Singh, and S. Singh, J. Pharm. Biomed. Anal., 26 , 1011–1040 (2001)
DOI :
Qute : Daszykowski, M. ,Sajewicz, M. ,Rzepa, J. ,Hajnos, M. ,Staszek, D. ,Wojtal, Ł. ,Kowalska, T. ,Waksmundzka-Hajnos, M. ,Walczak, B. ,Skalicka-Woźniak, K. ,Markowski, W. ,Świeboda, R. ,Głowniak, K. ,Sultana, N. ,Arayne, M. S. ,Naveed, S. ,Shamshad, H. ,Li, X. ,Xu, J. ,Jiang, Y. ,Chen, L. ,Xu, Y. ,Pan, C. ,Sheikhloie, H. ,Saber-Tehrani, M. ,Abrumand-Azar, P. ,Waqif-Husain, S. ,Mincea, M. ,Lupşa, I. ,Talpoş, I. ,Ostafe, V. ,Milenović, D. M. ,Todorović, Z. B. ,Rane, V. P. ,Patil, K. R. ,Sangshetti, J. N. ,Yeole, R. D. ,Shinde, D. B. ,Shinde, D. B. , Stability-indicating RP-HPLC method for analysis of eplerenone in the bulk drug and in a pharmaceutical dosage form. Acta Chromatographica Vol. 21, no. 4/2009
facebook