Background: Allergic rhinitis, acute nasal congestion and sinusitis are one of the most
common health problems and have a major effect on the quality of life. Several medications are
used to improve the symptoms of such diseases in humans. Pharmaceutical pomade form
containing Ephedrine (EPD) HCl, Naphazoline (NPZ) HCl, Antazoline (ANT) HCl, and
Chlorobutanol (CLO) is one of them.
Objective: For these reasons, this study includes the development of spectrophotometric and
chromatographic methods for the determination of EPD HCl, NPZ HCl, ANT HCl, and CLO
active agents in the pharmaceutical pomade.
Method: In the spectrophotometric method, third-order derivative of the amplitudes at 218 nm n=5
and the first-order derivative of the amplitudes 254 nm n=13 was selected for the determination of
EPD, ANT, respectively while NPZ was determined by the second derivative at 234 nm and n=21.
Colorimetric detection was applied for assay analysis of CLO at 540 nm. Furthermore, a reverse
phase high performance liquid chromatographic (RP- HPLC) method has been developed and
optimized by using Agilent Zorbax Eclipse XDB C18 (75 mm x 3.0 mm, 3.5μm) column. The
column temperature was 40°C, binary gradient elution was used and the mobile phase consisted of
15 mM phosphate buffer in distilled water (pH 3.0) and methanol, and the flow rate was 0.6 mL
min-1 and the UV detector was detected at 210 nm. The linear operating range was obtained as
11.97-70, 0.59-3, 2.79-30, and 2.92-200 μg mL-1 for EPD HCl, NPZ HCl, ANT HCl, and CLO
Results: The LOD values were found to be 3.95, 0.19, 0.92 and 0.96 μg mL-1 for EPD HCl, NPZ
HCl, ANT HCl, and CLO in the spectrophotometric method, respectively. The linear ranges in the
RP-HPLC method were 8.2-24.36 μg mL-1, 0.083 - 0.75 μg/mL, 2.01-7.5 μg mL-1 and 2.89-24.4
μg mL-1 for EPD HCl, NPZ HCl, ANT HCl, and CLO, respectively. The LOD values in the
validation studies were 2.7, 0.025, 0.66 and 0.86 μg mL-1 for EPD HCl, NPZ HCl, ANT HCl, and
CLO in RP-HPLC method respectively.
Conclusion: The results of the spectrophotometric and chromatographic methods were compared
and no differences were found between the two methods.