Spectrophotometric determination of sildenafil citrate in pure form and in pharmaceutical formulation using some chromotropic acid azo dyes

Spectrochim Acta A Mol Biomol Spectrosc. 2010 Apr;75(4):1297-303. doi: 10.1016/j.saa.2009.12.068. Epub 2010 Jan 6.

Abstract

Two simple and highly sensitive spectrophotometric methods were developed for the quantitative determination of the drug sildenafil citrate (SC), Viagra, in pure form and in pharmaceutical formulations, through ion-associate formation reactions (method A) with mono-chromotropic acid azo dyes, chromotrope 2B (I) and chromotrope 2R (II) and ion-pair reactions (method B) with bi-chromotropic acid azo dyes, 3-phenylazo-6-o-carboxyphenylazo-chromotropic acid (III), bis-3,6-(o-hydroxyphenylazo)-chromotropic acid (IV), bis-3,6-(p-N,N-dimethylphenylazo)-chromotropic acid (V) and 3-phenylazo-6-o-hydroxyphenylazo-chromotorpic acid (VI). The reaction products, extractable in methylene chloride, were quantitatively measured at 540, 520, 540, 570, 600 and 575 nm using reagents, I-VI, respectively. The reaction conditions were studied and optimized. Beer's plots were linear in the concentration ranges 3.3-87.0, 3.3-96.0, 5.0-115.0, 2.5-125.0, 8.3-166.7 and 0.8-15.0 microg mL(-1) with corresponding molar absorptivities 1.02 x 10(4), 8.34 x 10(3), 6.86 x 10(3), 5.42 x 10(3), 3.35 x 10(3) and 2.32 x 10(4)Lmol(-1) cm(-1) using reagents I-VI, respectively. The limits of detection and Sandell's sensitivities were calculated. The methods were successfully applied to the analysis of commercial tablets (Vigoran) and the recovery study reveals that there is no interference from the common excipients that are present in tablets. Statistical comparison of the results was performed with regard to accuracy and precision using Student's t- and F-tests at 95% confidence level. There is no significant difference between the reported and proposed methods with regard to accuracy and precision.

MeSH terms

  • Azo Compounds / chemistry*
  • Calibration
  • Coloring Agents / chemistry*
  • Hydrogen-Ion Concentration
  • Kinetics
  • Naphthalenesulfonates / chemistry*
  • Pharmaceutical Preparations / chemistry*
  • Piperazines / analysis*
  • Piperazines / chemistry
  • Purines / analysis
  • Purines / chemistry
  • Reference Standards
  • Reproducibility of Results
  • Sildenafil Citrate
  • Solvents / chemistry
  • Spectrum Analysis
  • Sulfones / analysis*
  • Sulfones / chemistry
  • Tablets
  • Temperature
  • Thermodynamics
  • Time Factors

Substances

  • Azo Compounds
  • Coloring Agents
  • Naphthalenesulfonates
  • Pharmaceutical Preparations
  • Piperazines
  • Purines
  • Solvents
  • Sulfones
  • Tablets
  • chromotrope 2R
  • Sildenafil Citrate
  • chromotropic acid