Atorvastatin 10 mg Tablet | 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 2 (paddle)

Medium: Purified Water

Quantity: 900 ml

RPM: 75

Time: 45 minutes

Temperature: 37⁰c ± 0.5⁰c

Range: NLT 75% of the labeled amount of Atorvastatin is dissolved within 45 minutes in water

Preparation of Standard Solution:

Weigh accurately about 11 mg WS of Atorvastatin Calcium & transfer it quantitively into a 100 ml volumetric flask. Add 50 ml medium & sonicate for 30 minutes to dissolve. Make volume up to the mark with the medium & 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.

Preparation of Sample Solution:

Take 900 ml of Purified water in each dissolution vessel. Assemble the apparatus & warm the media to 37⁰c ± 0.5⁰C. Place six tablets into the six individual dissolution vessels. Start the apparatus according to the mentioned condition & transfer about 25 ml solutions after 45  minutes from each vessel & filter. Transfer 10 ml of this solution to a 100 ml volumetric flask. Add 10 ml medium & make volume up to the mark with the medium & mix well.

Procedure:

Measure the absorbance of both standard & sample solution in 1 cm cell at 241 nm with a suitable Spectrophotometer using water as a blank solution.

Calculation:

Atorvastatin dissolved after 45 minutes in water

Where,

At = Absorbance of Test Sample

Ws = Weight of Working Standard

P = Potency of Working Standard

Wt = Label Claim

As = Absorbance of Working Standard

0.9354838 = Factor of Atorvastatin Calcium to Convert Atorvastatin

Results:

Atorvastatin 10 mg Tablet from Pharmaceutical-1:

Vessel No.	Absorbance of WS	Potency of WS	Absorbance of Sample	Result	Average
1	0.540	99.50	0.580	98.97%	97.91%
2			0.574	97.95%
3			0.578	98.63%
4			0.575	98.12%
5			0.570	97.26%
6			0.566	96.58%

Atorvastatin 10 mg Tablet from Pharmaceutical-2:

Vessel No.	Absorbance of WS	Potency of WS	Absorbance of Sample	Result	Average
1	0.540	99.50	0.578	98.63%	97.92%
2			0.577	98.46%
3			0.572	97.61%
4			0.574	97.95%
5			0.570	97.26%
6			0.572	97.61%

Conclusion:

The active substance and strength of Atorvastatin 10 mg Tablet from Pharmaceutical-1 is the same as that of Atorvastatin 10 mg Tablet from Pharmaceutical-2; the pharmaceutical form is the same. The dissolution results of both Tablets in Purified water are nearly the same. So, it is concluded that Atorvastatin 10 mg Tablet from Pharmaceutical-1 & Atorvastatin 10 mg Tablet from Pharmaceutical-1 contain the same active ingredients.