تطوير طريقة ضوئية و أخرى بالاستشراب السائل عالي الأداء لمعايرة الأزيلاستين بوصفه مادة أولية و في أشكاله الصيدلانية

الملخص EN

In this research two analytical methods were developed for the determination of Azelastin as raw material and in Nasal Spray formulation.

The first method was spectrophotometric while the other used the technic of HPLC The first method based on measuring the absorbance at λmax 284 nm .

The relationship between the absorbance and the concentration is rectilinear over the range 0.001 – 0.008 g %.

The proposed spectrophotometric method was successfully applied to the determination of Azelastin in nasal spray.

The percentage recoveries were 99.378±1 (10 duplicate readings)1 No interference was noticed from co-formulated drugs.

For the absorbance at λmax the obtained results were in good agreement with which obtained by the Pharmacopeia method.

In addition, a method was developed for was developed to determine the same substance relying on the use of HPLC techniqce, achieved on HPLC separation column ODS C18 (25cm × 4.6 nm).

While the mobile phase was acetonitrile, phosphate buffer 1:1 with isocratic mode.

The substance gave a good separation while the retention time was 1.467 min.