THREE-WAVELENGTH SPECTROPHOTOMETRIC METHOD VALIDATION FOR DETERMINATION OF PREDNISONE TABLET CONTAINING COLORING DYES

Abstract

Asthma is a chronic inflammatory disease that ranks
fifth out of the top ten causes of morbidity1. The
drug therapy commonly used for asthma is
corticosteroid, for example is prednisone2. The
determination of the drug in the pharmaceutical
dosage form is very important to ensure its safety
and efficacy. Assay method of prednisone in tablet
according to Farmakope Indonesia is using High
Performance Liquid Chromatography (HPLC)3, which
has good accuracy and precision, but high cost and
took a longer analysis time. These aspects are
making it less suitable for quality control on a regular
basis. UV-Vis spectrophotometry method could be
used as the alternative assay method to determine
prednisone in tablet, as prednisone has
chromophore and auxochrome groups4. UV-Vis
spectrophotometry method has shorter analysis
times and lower operating costs while still providing
a high precision5. Spectrophotometric method UVVis
has been used in previous studies of prednisone
and proven to give good results, for example in the
dissolution test6,7. Singh and Verma8 conducted
research to determine prednisone in tablets based
on the color occurred after prednisone reacted with
FeCl3 and K4Fe(CN)6, forming a blueish green
solution. The solution then measured by
spectrophotometer giving the analytical wavelength
at 780 nm.
The addition of coloring agents in pharmaceutical
preparations intended to identify products in
production and distribution, distinguishing the same
dose of the drug, preventing product counterfeiting
and stability indicators9. However, coloring agent or
dye in the formulation could affect the analysis
process, such as background interfering in the
analytical instrument measurement. In Indonesia,
usually we can find prednisone tablet in green color.
Dyes used in this study is a mix of light green and
tartrazine resulting in a light green color. These dyes
also have a cluster of chromophore and auxochrome
to provide absorbance in the UV-Vis spectrum
region. Observing the prednisone solution containing
0.1% light green and tartrazine solution at the
maximum wavelength of prednisone (238 nm) will
give absorbance of the solution 5% higher.
To overcome this problem, the analysis of the
spectrophotometry is applied by multi-wavelength
method. Dual- or three-wavelength
spectrophotometry methods are very useful to
eliminate the absorbance influence of interfering
components.
a.
b.
c.
Figure 1. Chemical Structure of : a. Prednisone, b. Light
green dye, c. Tartrazine
The aim of this research was validating threewavelength
spectrophotometry method to
determine prednisone in tablet, containing coloring
dyes. The method validation parameters defined in
this research are the