Dissolution
condition:
Medium : 0.1 N hydrochloric acid; 900 ml
Apparatus : Paddle
Speed : 50 RPM
Time : 30 minutes
Temperature : 37°C (± 0.5°C)
Method:
Introduce the dissolution medium in
to the vessel of the apparatus. Warm the dissolution medium to between 36.5°C and 37.5°C. Introduce one tablet in each
vessel and operate the apparatus as per above conditions.
Standard solution: Transfer 50 mg of Ketoconazole WS to a 100-ml volumetric flask. and make up the volume with medium.
Further dilute 5 ml of above solution to 50 ml with medium.
Sample solution: Pass through a
filter having a porosity of 0.45 µm, and dilute 10 ml of filter to 50 ml with
medium.
Measure the absorbance of standard
and sample solution at maximum about 270 nm.
Calculate the content of C26H28Cl2N4O4
in the medium from the absorbance obtained from a solution of known
concentration of Ketoconazole WS in the same medium.
