Rabeprazole 20 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 (Acid Stage):

Apparatus: Type 2 (Paddle)

Medium: 0.1N Hydrochloric Acid

Quantity: 900 ml

RPM: 100

Time: 120 minutes

Temperaturte: 37⁰c ± 0.5⁰c

Range: NMT 10 % of the labeled amount of Rabeprazole is dissolved within 120 minutes

Preparation of Standard Solution (Acid Stage):

Weigh accurately about 11 mg WS of Rabeprazole & transfer 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.

Preparation of Sample Solution (Acid Stage):

Take 900 ml 0.1 M HCl 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 50 ml solutions after 120 minutes from each vessel & filter. Transfer 25 ml of this solution to a 50 ml volumetric flask & make volume up to the mark with the 0.1 M HCl & mix well.

Procedure (Acid Stage):

Measure the absorbance of both standard & sample solution in a 1 cm cell at 236 nm with a suitable Spectrophotometer using 0.1N HCL as a blank solution.

Calculation (Acid Stage):

Rabeprazole dissolves after 120 minutes in 0.1N HCL

Where,

At = Absorbance of Test Sample

Ws = Weight of Working Standard

P = Potency of Working Standard

Wt = Label claim

As = Absorbance of Working Standard

Apparatus Condition (Buffer Stage):

Apparatus: Type 2 (Paddle)

Medium: 6.8 Phosphate Buffer

Quantity: 900 ml

RPM: 100

Time: 45 min

Temperaturte: 37⁰c ± 0.5⁰c

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

Preparation of Standard Solution (Buffer Stage):

Weigh accurately about 11 mg WS of Rabeprazole & transfer 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.

Preparation of Sample Solution (Buffer Stage):

Take 900 ml 6.8 Phosphate Buffer 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 50 ml solutions after 45 minutes from each vessel & filter. Transfer 25 ml of this solution into a 50 ml volumetric flask & make volume up to the mark with the 6.8 Phosphate Buffer & mix well.

Procedure (Buffer Stage):

Measure the absorbance of both standard & sample solution in a 1 cm cell at 236 nm with a suitable Spectrophotometer using 6.8 Phosphate Buffer as a blank solution.

Calculation (Buffer Stage):

Rabeprazole dissolves after 45minutes in 6.8 Phosphate Buffer

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 (Acid Stage):

Rabeprazole 20 mg Tablet from Pharmaceuticals-1:

Vessel No.	Absorbance of  WS	Potency of WS	Absorbance of Sample	Result	Average
1	0.265	99.00%	0.022	8.13%	7.88%
2			0.024	8.87%
3			0.021	7.76%
4			0.019	7.02%
5			0.020	7.39%
6			0.022	8.13%

Rabeprazole 20 mg Tablet from Pharmaceuticals-2:

Vessel No.	Absorbance of  WS	Potency of WS	Absorbance of Sample	Result	Average
1	0.265	99.00%	0.020	7.39%	7.69%
2			0.023	8.50%
3			0.019	7.02%
4			0.022	8.13%
5			0.021	7.76%
6			0.020	7.39%

Results (Buffer Stage):

Rabeprazole 20 mg Tablet from Pharmaceuticals-1

Vessel No.	Absorbance of  WS	Potency of WS	Absorbance of Sample	Result	Average
1	0.644	99.00%	0.597	90.85%	92.37%
2			0.610	92.83%
3			0.607	92.37%
4			0.615	93.59%
5			0.605	92.07%
6			0.608	92.53%

Rabeprazole 20 mg Tablet from Pharmaceuticals-2

Vessel No.	Absorbance ofWS	Potency of WS	Absorbance of Sample	Result	Average
1	0.644	99.00%	0.604	91.92%	92.09%
2			0.606	92.22%
3			0.596	90.70%
4			0.600	91.31%
5			0.614	93.44%
6			0.611	92.98%

Conclusion:

The active substance and strength of Rabeprazole 20 mg Tablet from Pharmaceuticals-1 is the same as that of Rabeprazole 20 mg Tablet from Pharmaceuticals-2; the pharmaceutical form is the same. Dissolution results of both tablets in acid stage & buffer stage are nearly the same. So, it is concluded that Rabeprazole 20 mg Tablet from Pharmaceuticals-1 & Rabeprazole 20 mg Tablet from Pharmaceuticals-2 contain the same active ingredients.