Disolusi Tablet Paracetamol Dengan Menggunakan Dapar Fosfat Ph 7.2
Disolusi Tablet Paracetamol Dengan Menggunakan Dapar Fosfat Ph 7.2

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Complete Recipe: Paracetamol Tablet Dissolution Using Phosphate Buffer pH 7.2

This article provides a comprehensive guide on performing a paracetamol tablet dissolution test using phosphate buffer pH 7.2. This is a common method used in pharmaceutical analysis to determine the rate at which a drug dissolves under specific conditions, a crucial factor in bioavailability and drug efficacy. This recipe focuses on accuracy and reproducibility, key aspects of any successful scientific experiment.

Keywords: Paracetamol, Dissolution Test, Phosphate Buffer, pH 7.2, USP Dissolution Apparatus, Pharmaceutical Analysis, Bioavailability, Drug Release, In-vitro Dissolution

I. Materials and Equipment

Before embarking on the dissolution test, ensure you have gathered all the necessary materials and equipment. This comprehensive list will help prevent any delays or disruptions during the procedure.

A. Materials:

  • Paracetamol Tablets: A batch of paracetamol tablets of known strength (e.g., 500mg). Ensure the tablets are from a homogenous batch and stored appropriately.
  • Phosphate Buffer pH 7.2: This is the dissolution medium. The exact recipe for preparing this buffer is detailed in Section II. Ensure the pH is accurately adjusted using a pH meter.
  • Hydrochloric Acid (HCl) and Sodium Hydroxide (NaOH): These are needed to adjust the pH of the buffer solution. Use concentrated solutions cautiously and always add acid to water, never water to acid.
  • Deionized Water: Use only high-purity water throughout the procedure to prevent interference.

B. Equipment:

  • USP Dissolution Apparatus (Basket or Paddle Method): This is the apparatus that will perform the dissolution test. The apparatus type will influence the method and interpretation of results. Ensure it's properly calibrated.
  • Analytical Balance: Used to accurately weigh the paracetamol tablets. Accuracy is critical for reliable results.
  • Volumetric Flasks: For precise preparation of the phosphate buffer solution.
  • Pipettes: For accurate sampling during the dissolution testing.
  • UV-Vis Spectrophotometer: Used to quantify the amount of paracetamol dissolved at different time points. Ensure it’s calibrated using a known standard.
  • pH Meter: To accurately check the pH of the prepared phosphate buffer solution.
  • Water Bath: To maintain the temperature of the dissolution media.
  • Timer: To accurately record the time points for sampling.

II. Preparing the Phosphate Buffer pH 7.2

Accurate preparation of the buffer is vital. Inaccurate pH can significantly affect the dissolution rate of the Paracetamol.

A. Recipe: Specific quantities of monobasic potassium phosphate (KH2PO4) and dibasic potassium phosphate (K2HPO4) are required to achieve a pH of 7.2. The exact quantities depend on the desired buffer concentration and volume. Consult a reliable scientific resource or pharmaceutical text book for accurate calculations based on desired concentration and volume of buffer solution.

B. Procedure:

  1. Accurately weigh out the calculated amounts of KH2PO4 and K2HPO4.
  2. Dissolve these salts in a portion of deionized water.
  3. Adjust the pH to 7.2 using small additions of either HCl or NaOH. Constant stirring is necessary for homogenous mixing and accurate pH adjustments.
  4. Dilute the solution to the desired final volume with deionized water.

III. Performing the Dissolution Test

This section outlines the step-by-step procedure for the dissolution test itself. Strict adherence to these steps ensures reliable and reproducible results.

A. Preparation:

  1. Fill the dissolution vessels of the apparatus with the prepared phosphate buffer pH 7.2, maintaining a consistent temperature (usually 37Β°C).
  2. Weigh the paracetamol tablet accurately.
  3. Place the tablet in the vessel.
  4. Start the apparatus and begin timing.

B. Sampling and Analysis:

  1. At predetermined time intervals (e.g., 5, 10, 15, 20, 30, 45, and 60 minutes), withdraw a sample using a pipette.
  2. Filter the samples to remove any undissolved particles.
  3. Analyze the samples using UV-Vis Spectrophotometry at a suitable wavelength.
  4. Use a suitable calibration curve (prepared using known concentrations of Paracetamol in the buffer) to calculate the concentration of Paracetamol in each sample.

C. Data Analysis:

The obtained data (time vs. concentration) will allow you to determine the dissolution rate of the paracetamol tablets. Standard dissolution profiles like the dissolution efficiency (DE) and the percentage dissolved at specified time points can be calculated and reported. Statistical analysis may be helpful.

IV. Safety Precautions

Always follow appropriate laboratory safety procedures while conducting this experiment. This includes wearing personal protective equipment (PPE) such as gloves and eye protection, working in a well-ventilated area, and handling chemicals responsibly. Dispose of waste materials properly.

This comprehensive guide provides a detailed recipe for the dissolution test, but remember that specific details may need adjustments based on the regulatory requirements and the purpose of the study. Consult relevant pharmacopoeias and scientific literature for best practices and appropriate validation procedures. Accurate execution and rigorous data analysis are paramount in ensuring reliable results.


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