Pantoprazole 40 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

Temperature: 37⁰c ± 0.5⁰c

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

Preparation of Standard Solution (Acid Stage):

Weigh accurately about 22 mg WS of Pantoprazole & 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 289 nm with a suitable Spectrophotometer using 0.1N HCL as a blank solution.

Calculation (Acid Stage):

Pantoprazole 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

Temperature: 37⁰c ± 0.5⁰c

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

Preparation of Standard Solution (Buffer Stage):

Weigh accurately about 22 mg WS of Pantoprazole & transfer quantitively into a 100 ml volumetric flask. Add 10 ml methanol & shake well 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 (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 to a 50 ml volumetric flask. Add 10 ml methanol & make the volume up to the mark with the medium & mix well.

Procedure (Buffer Stage):

Measure the absorbance of both standard & sample solution in a 1 cm cell at 289 nm with a suitable Spectrophotometer using 6.8 Phosphate Buffer as a blank solution.

Calculation (Buffer Stage):

Pantoprazole 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):

Pantoprazole 40 mg Tablet from Pharmaceuticals-1:

Vessel No.	Absorbance of  WS	Potency of WS	Absorbance of Sample	Result	Average
1	0.312	88.40 %	0.022	6.17%	6.54%
2			0.023	6.45%
3			0.024	6.73%
4			0.022	6.17%
5			0.025	7.01%
6			0.022	6.73%

Pantoprazole 40 mg Tablet from Pharmaceuticals-2:

Vessel No.	Absorbance of  WS	Potency of WS	Absorbance of Sample	Result	Average
1	0.312	88.40%	0.025	7.01%	6.68%
2			0.022	6.17%
3			0.023	6.45%
4			0.024	6.73%
5			0.023	6.45%
6			0.026	7.29%

Results (Buffer Stage):

Pantoprazole 40 mg Tablet from Pharmaceuticals-1:

Vessel No.	Absorbance of  WS	Potency of WS	Absorbance of Sample	Result	Average
1	0.574	88.40 %	0.599	91.32%	91.22%
2			0.600	91.48%
3			0.601	91.63%
4			0.595	90.71%
5			0.597	91.02%
6			0.598	91.17%

Pantoprazole 40 mg Tablet from Pharmaceuticals-2:

Vessel No.	Absorbance of  WS	Potency of WS	Absorbance of Sample	Result	Average
1	0.574	88.40%	0.602	91.78%	91.50%
2			0.603	91.93%
3			0.598	91.17%
4			0.607	92.54%
5			0.596	90.87%
6			0.595	91.71%

Conclusion:

The active substance and strength of Pantoprazole 40 mg Tablet from Pharmaceuticals-1 is the same as that of Pantoprazole 40 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 Pantoprazole 40 mg Tablet from Pharmaceuticals-1 & Pantoprazole 40 mg Tablet from Pharmaceuticals-1 contain the same active ingredients.