Fluconazole 150 mg Capsule | Comparative Dissolution Study

Dissolution testing has emerged in the pharmaceutical field as a very important tool to characterize drug product performance. Drug absorption from a solid dosage form after oral administration depends on the release of the drug substance from the drug product, the dissolution or solubilization of the drug under physiological conditions, and the permeability across the gastrointestinal tract.

Apparatus Condition:

Apparatus: Type 1 (Basket)

Medium: Purified water

Quantity: 900 ml

RPM: 50

Time: 45 minutes

Temperature: 37⁰c ± 0.5⁰c

Range: NLT 75% of the labeled amount of Fluconazole is dissolved within 45 minutes

Preparation of Buffer Solution:

0.01M anhydrous sodium acetate solution & adjust with glacial acetic acid to a pH of 5.0

Mobile Phase:

Methanol:Acetonitrile:Buffer = 20:10:70      

Preparation of Standard Solution:

Weigh accurately about 16 mg WS of Fluconazole & transfer it quantitively into a 100 ml volumetric flask. Add 30 to 35 ml medium & shake well to dissolve. Make volume up to the mark with the same & mix well. Transfer 10 ml of this solution to another 100 ml volumetric flask & make the volume up to the mark with the medium & mix well. Filter the solution through 0.2 µm.

Preparation of Sample Solution:

Take 900 ml of Purified water media in each dissolution vessel. Assemble the apparatus & warm the media to 37⁰c ± 0.5⁰C. Place six Capsules into the six individual dissolution vessels. Start the apparatus according to the mentioned condition & transfer about 40 ml of solutions after 45 minutes from each vessel & filter. Transfer 10 ml of this solution to a 100 ml volumetric flask & make the volume up to the mark with the medium & mix well. Filter the solution through 0.2 µm.

Chromatographic System:

Column:  3.9 m x 150 mm 

Wavelength:  261 nm 

Flow Rate: 1ml/minute

Injected Volume: 20 µl

Procedure:

Separately inject 20 µl of the standard preparation and test preparations into the chromatogram. Record the chromatogram and measure the peak’s response to the standard preparation and test preparation.

Calculation:

Fluconazole dissolved after 45 minutes

Where,

At = Peak Area of The Test Sample

Ws = Weight of Working Standard

P = Potency of Working Standard

Wt = Label Claim

As = Peak Area of Working Standard 

Fluconazole 150 mg Capsule from Pharmaceuticals-1:

Vessel No.	Peak Area of Ws	Potency of Ws	Peak Area of Test Sample	Result	Average
1	24098	99.67%	24512	97.32%	97.68%
2			22965	97.72%
3			24810	98.41%
4			24614	97.73%
5			24556	97.50%
6			24541	97.44%

Fluconazole 150 mg Capsule from Pharmaceuticals-2:

Vessel No.	Peak Area of Ws	Potency of Ws	Peak Area of Test Sample	Result	Average
1	24098	99.67%	24714	98.12%	97.45%
2			24520	97.35%
3			24411	96.92%
4			24489	97.23%
5			24502	97.28%
6			24638	97.82%

Conclusion:

The active substance and strength of Fluconazole 150 mg Capsule from Pharmaceuticals-1 is the same as that of Fluconazole 150 mg Capsule from Pharmaceuticals-2; the pharmaceutical form is the same. The dissolution results of both capsules in the dissolution medium are nearly the same. So, it is concluded that Fluconazole 150 mg Capsule from Pharmaceuticals-1 & Fluconazole 150 mg Capsule from Pharmaceuticals-2 contain the same active ingredients.