Page 67 - Practical Technology 2025

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Clinical Pharmacy-Pharm D Level Three 2 Semester 2024/2025 Pharmaceutical Technology (PT 607)

Procedure:

1- The dissolution vessels are filled up with buffered solution to 900 mL.

2- The temperature of the dissolution medium is checked to ensure that it is 37± 0.5 °C.

3- One tablet of acetaminophen is put into each of the dry basket.

4- The stirring speed is set to 100 rpm. Then, the baskets are lower assembly into the
position in the vessel and the operation is started.

5- After 30 minutes, 5 ml of the samples of the dissolution medium from each of the vessel

are withdrawn for analysis and the solution is filtered using a syringe filter. Sampling

should be done from middle point between the surface of the dissolution medium and
the top of rotating basket, and not less than 10 mm form the wall of the vessel. The

volume of aliquot withdrawn for analysis is replaced with the same volume of same
dissolution medium.

6- A standard calibration curve is constructed by preparing different concentration of

acetaminophen and measuring the absorbance of each concentration at 243 nm.

7- The percentage amount of drug dissolved is calculated by using the calibration curve.

8- From the result obtained, the tablet compliance with the requirements of the United

States Pharmacopoeia is determined.

USP limits : Not less than 80 % of the stated amount of acetaminophen
dissolved in 30 minutes.

Rule:
% Drug dissolved =

( / ) × × ( ) × 100

Dilution factor =

65