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Development of Spectrophotometric and Validated Stability-Indicating RP-HPLC Methods for Simultaneous Determination Of Ephedrine HCL, Naphazoline HCL, Antazoline HCL, and Chlorobutanol In Pharmaceutical Pomade Form

Author(s):

Çiğdem Kanbeş Dindar, Cem Erkmen, Bengi Uslu* and Nilgün Günden Göğer   Pages 1 - 20 ( 20 )

Abstract:


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 determination of EPD HCl, NPZ HCl, and ANT HCl and CLO active agents in pharmaceutical pomade.

Method: In 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. Linear operating range was obtained as 11.97-70, 0.59-3, 2.79-30 and -200 µg mL-1 for EPD HCl, NPZ HCl, ANT HCl, and CLO respectively.

Results and Conclusion: 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 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. The results of the spectrophotometric and chromatographic methods were compared and no differences were found between the two methods.

Keywords:

Antazoline, Chlorobutanol, Ephedrine, Determination, Naphazoline, RP-HPLC, UV-Derivative Spectrophotometry, Validation

Affiliation:

Gazi University, Faculty of Pharmacy, Department of Analytical Chemistry, 06330 Ankara, Ankara University, Faculty of Pharmacy, Department of Analytical Chemistry, 06560 Ankara, Ankara University, Faculty of Pharmacy, Department of Analytical Chemistry, 06560 Ankara, Gazi University, Faculty of Pharmacy, Department of Analytical Chemistry, 06330 Ankara



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