Aceclofenac 100 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.

Aceclofenac is a nonsteroidal anti-inflammatory drug (NSAID). It is used to relieve pain and inflammation in rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis.

It was patented in 1983 and approved for medical use in 1992.

There are several dosage forms and strengths available with Aceclofenac. The most common of which is Aceclofenac 100 mg Tablet.

Each film-coated tablet contains Aceclofenac BP 100 mg. The comparative dissolution study between Aceclofenac 100 mg Tablet from Pharmaceuticals-1 and Aceclofenac 100 mg Tablet from Pharmaceuticals-2 are as below:

Apparatus Condition:

Apparatus: Type 2 (paddle)

Medium: Phosphate Buffer, pH 6.8

Quantity: 900 ml

RPM: 75

Time: 45 minutes

Temperature: 37⁰c ± 0.5⁰c

Range: NLT 75% of the labeled amount of Aceclofenac is dissolved within 45 minutes in Phosphate Buffer, pH 6.8

Preparation of Standard Solution:

Weigh accurately about 11 mg WS of Aceclofenac & transfer quantitively into a 100 ml volumetric flask. Add 50 ml medium & shake mechanically 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 into 100 ml volumetric flask & volume with medium & mix well.

Procedure:

Measure the absorbance of both standard & sample solution in a 1 cm cell at 266 nm with a suitable Spectrophotometer using 6.8 Phosphate buffer as a blank solution.

Calculation:

Aceclofenac  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

Results:

Aceclofenac 100 mg Tablet from Pharmaceutical-1:

Vessel No.	Absorbance of  WS	Potency of WS	Absorbance of Sample	Result	Average
1	0.302	99.56%	0.300	97.91%	97.30%
2			0.301	98.23%
3			0.297	96.93%
4			0.297	96.93%
5			0.298	97.25%
6			0.296	96.60%

Aceclofenac 100 mg Tablet from Pharmaceutical-2:

Vessel No.	Absorbance of  WS	Potency of WS	Absorbance of Sample	Result	Average
1	0.302	99.56%	0.299	97.58%	97.52%
2			0.300	97.91%
3			0.300	97.91%
4			0.298	97.25%
5			0.297	96.93%
6			0.299	97.58%

Conclusion:

The active substance and strength of Aceclofenac 100 mg Tablet from Pharmaceutical-1 is the same as that of Aceclofenac 100 mg Tablet from Pharmaceutical-2; the pharmaceutical form is the same. The dissolution results of both tablets in the dissolution medium are nearly the same. So, it is concluded that Aceclofenac 100 mg Tablet from Pharmaceutical-1 & Aceclofenac 100 mg Tablet from Pharmaceutical-2 contain the same active ingredients.