Operating Procedure:

I. Preparation of dissolution media

1. Place 900 mL plain, distilled water in each of the six- 1L glass beakers.
2. Place the beakers on the hot plate and heat until it reaches 37 degrees Celsius (+/-5).
3. Monitor the temperature with a thermometer.
4. Keep the temperature constant.
5. Set aside.
II. Preparation of Amoxicillin reference standard solution
1. Weigh exactly 100mg of the standard amoxicillin powder in a watch glass.
2. Add about 70 mL of distilled water to a 100 mL volumetric flask. Add the weigh
standard amoxicillin powder. Cover and shake the flask to completely dissolve the
powder.
3. Wash the watch glass with portions of distilled water and add the rinsing to the
volumetric flask. Fill to the mark with more distilled water to make 100 mL solution.
Mix thoroughly. This is the first dilution.
4. Using a pipet, transfer 1 mL of the first dilution to another 100 mL volumetric flask.
Dilute with more distilled water to make 100 mL solution. This is the final dilution that
contains 10mcg/mL amoxicillin.
III. Preparation of the dosage unit samples
1. Weigh 8 capsules and take the average weight.
2. Take 6 capsules and weigh individually using an analytical balance for use in the test.
IV. Assembly and operation of the dissolution apparatus
1. Pour in a clear acrylic water bath a suitable amount of tap water.
2. Turn on the soft flow heater to maintain the desired temperature for testing.
3. Place the six-1L glass vessels into the large holes of the base fasten properly with the
clips.
4. Fill the six 1L glass vessels with the 900 mL of previously heated distilled water. Cover
each vessel.
5. Stabilize the temperature to 37 degrees Celsius.
6. Set the height of each basket shaft to 25 mm (+/-2) from the bottom of each vessel.
7. Set the basket speed to 100rpm.
8. Place 1 capsule in each of the six cylindrical baskets.
9. Snap the capsule filled basket onto the metal shaft, previously placed in the apparatus.
10. Lower the cylindrical baskets to the desired height and turn the speed control to
100rpm.
11. After 30 minutes, withdraw an aliquout portion equivalent to 0.5mg of amoxicillin,
passing the portions through a filter. Dilute 50 mL of the medium in 50 mL volumetric
flask.
12. Aliquot sampling should be carried out from the point midway between the tip of the
paddle and the surface of the medium and no less than 1cm from the vessel walls.
13. The final dilution should contain about 10mcg/mL.
14. Determine the absorbance of each of the six capsules at a wavelength of maximum
aborbance at 272nm in comparison with a standard having 10mcg/mL in the final
dilution.
15.Calculate the amount of amoxicillin absorbed in solution per capsule and the
%labelled claim of each capsule.