Stability-indicating RP-HPLC method for analysis of eplerenone in the bulk drug and in a pharmaceutical dosage form

Acta Chromatographica

Volumn 21, Issue 4, 2009, Pages 619-629

  Rane, V ^a,b   Patil, K ^a,b   Sangshetti, J ^b   Yeole, R ^b   Shinde, D ^a  

^a DR BABASAHEB AMBEDKAR MARATHWADA UNIVERSITY   (India)

^b Wockhardt Research Centre   (India)

Author keywords

Dosage form; Eplerenone; Forced degradation; Method validation; RP HPLC

Indexed keywords

EID: 73249122811     PISSN: 12332356     EISSN: 20835736     Source Type: Journal    
DOI: 10.1556/AChrom.21.2009.4.8     Document Type: Article

References (14)

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)