Voltammetric reduction of finasteride at mercury electrode and its determination in tablets.

Finasteride in hydroalcoholic solutions (ethanol/Britton-Robinson buffer, 30/70) exhibits cathodic response in a wide range of pH (-0.5 to 12) using differential pulse (DPP) and test polarography (TP). The reduction peak of finasteride at acidic pH, is a catalytic proton peak resulting from a mechanism involving a first protonation of finasteride followed by the reduction of the protons combined with finasteride in order to regenerate finasteride and liberate hydrogen. Based on the catalytic hydrogen wave, a novel method for the determination of finasteride can be proposed. For analytical purposes we selected DPP technique in an ethanol/0.0625 mol L(-1) H(2)SO(4) (30/70) solution medium. In this condition the I(p) varied linearly with finasteride concentration between 5 x 10(-5) and 5 x 10(-4) mol L(-1). Within-day and inter-day reproducibility's were adequate with R.S.D. values lower than 2%. The selectivity of the method was checked with both accelerated degradation trials and typical excipients formulations. The developed method was applied to the assay and the uniformity content of finasteride tablets and compared with the standard HPLC method. The DPP-developed method was adequate for the finasteride determination in pharmaceutical forms as that exhibited an adequate accuracy, reproducibility and selectivity. Furthermore, treatment of the sample was not required as in HPLC; the method is not time-consuming and less expensive than the HPLC ones.

[1]  V H Price,et al.  Treatment of hair loss. , 1999, The New England journal of medicine.

[2]  A. Syed,et al.  LC determination of finasteride and its application to storage stability studies. , 2001, Journal of pharmaceutical and biomedical analysis.

[3]  R. Myers,et al.  Mechanism-Based Inhibition of Human Steroid 5α-Reductase by Finasteride:  Enzyme-Catalyzed Formation of NADP−Dihydrofinasteride, a Potent Bisubstrate Analog Inhibitor , 1996 .

[4]  D. Ifa,et al.  Bioequivalence Study of Finasteride , 2001, Arzneimittelforschung.

[5]  A. K. Cucu,et al.  Determination of finasteride in the tablet form by liquid chromatography and its analytical method validation , 2006 .

[6]  Julia C. O'Neill,et al.  Statistical Techniques for Data Analysis , 2005, Technometrics.

[7]  C. Roehrborn,et al.  The effect of finasteride on the risk of acute urinary retention and the need for surgical treatment among men with benign prostatic hyperplasia , 1998 .

[8]  B. Matuszewski,et al.  Matrix effect in quantitative LC/MS/MS analyses of biological fluids: a method for determination of finasteride in human plasma at picogram per milliliter concentrations. , 1998, Analytical chemistry.

[9]  R. C. Graham,et al.  Data analysis for the chemical sciences: A guide to statistical techniques , 1993 .

[10]  Yizeng Liang,et al.  A rapid, simple, specific liquid chromatographic-electrospray mass spectrometry method for the determination of finasteride in human plasma and its application to pharmacokinetic study. , 2007, Journal of pharmaceutical and biomedical analysis.

[11]  M. Thevis,et al.  Doping-Control Analysis of the 5α-Reductase Inhibitor Finasteride: Determination of Its Influence on Urinary Steroid Profiles and Detection of Its Major Urinary Metabolite , 2007, Therapeutic drug monitoring.

[12]  G. G. Stokes "J." , 1890, The New Yale Book of Quotations.

[13]  F. Botrè,et al.  A fast liquid chromatographic/mass spectrometric screening method for the simultaneous detection of synthetic glucocorticoids, some stimulants, anti-oestrogen drugs and synthetic anabolic steroids. , 2006, Rapid communications in mass spectrometry : RCM.

[14]  M. J. Jorgenson,et al.  A Critical Re-evaluation of the Hammett Acidity Function at Moderate and High Acid Concentrations of Sulfuric Acid. New H0 Values Based Solely on a Set of Primary Aniline Indicators , 1963 .

[15]  M. Serio,et al.  5α-Reductase Inhibitors, Chemical and Clinical Models , 1998, Steroids.

[16]  K. Akimoto,et al.  A new approach to evaluating photo-stability of nifedipine and its derivatives in solution by actinometry. , 1988, Chemical & pharmaceutical bulletin.

[17]  S. Amer Polarographic behavior and determination of finasteride. , 2003, Farmaco.

[18]  B. Buszewski,et al.  DETERMINATION OF FINASTERIDE AND RELATED COMPOUNDS BY REVERSED-PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY. I. CHOOSING THE MOBILE PHASE COMPOSITION , 1999 .

[19]  B. Girard,et al.  Bioequivalence Study of Two Different Coated Tablet Formulations of Finasteride in Healthy Volunteers , 2005, Arzneimittelforschung.

[20]  S. Saǧlik,et al.  Development and validation of a new gas flame ionization detector method for the determination of finasteride in tablets. , 2006, Analytical biochemistry.