PSPA Blok IV - 06 Uji Disolusi (Update April 2022)

Summary

The video provides a detailed step-by-step demonstration of the dissolution testing of 500 mg Amoxicillin tablets according to the Indonesian Pharmacopoeia. It covers the preparation of the dissolution medium, setup and calibration of the testing apparatus, sample collection at defined intervals, and analysis using HPLC. The tutorial explains how to calculate drug concentration, correct for sampling factors, and determine the percentage of drug dissolved at each time point. The results show that 93.45% of the Amoxicillin dissolves within 30 minutes, exceeding the required 75%, confirming that the tablets meet the dissolution specifications. The video concludes with data interpretation and final remarks.

Takeaways

• 😀 The dissolution test of Amoxicillin 500 mg tablets uses a solution tester with a medium of 900 mL distilled water (aquades).
• 😀 The testing chamber is filled with the medium, and the tablet is placed without touching the bottom of the chamber, with the chamber cover securely installed.
• 😀 The dissolution test parameters are set to 37°C temperature, 75 rpm paddle speed, and a total testing time of 30 minutes.
• 😀 Samples are taken at regular intervals: 0, 5, 10, 15, 20, 25, and 30 minutes using a sampling device.
• 😀 Each sample is processed in a 10 mL volumetric flask and diluted with distilled water to prepare for analysis.
• 😀 Amoxicillin concentration in the samples is measured using High-Performance Liquid Chromatography (HPLC) following the Indonesian Pharmacopeia 6th edition.
• 😀 A calibration curve is prepared to obtain a regression equation, allowing calculation of the concentration of Amoxicillin in micrograms per milliliter.
• 😀 Sample concentrations are converted to the amount of drug in milligrams, and a correction factor is applied to account for previously removed samples.
• 😀 Percent dissolution is calculated by dividing the corrected drug amount by the tablet's labeled content and multiplying by 100%.
• 😀 The dissolution results at 30 minutes show 93.45% of the drug dissolved, exceeding the minimum 75% standard, confirming that the tablet meets dissolution requirements.
• 😀 The value of Q for the final minute is based on the percent dissolved at 30 minutes, used as the official result for the dissolution test.
• 😀 The entire process follows systematic steps: preparation of medium and equipment, setting parameters, sampling, analysis, data correction, and calculation of percent dissolved.

Q & A

What is the purpose of the dissolution test performed in the transcript?

The dissolution test is conducted to measure the rate and extent at which the Amoxicillin 500 mg tablet dissolves in a medium under controlled conditions, ensuring it meets the standards specified in the Indonesian Pharmacopoeia.

What type of medium and volume is used for the dissolution test?

The medium used is aquadest (distilled water), with a total volume of 900 mL in the dissolution chamber.

What are the standard conditions for temperature, speed, and time in the test?

The test is conducted at 37°C with a paddle speed of 75 rpm, and the total duration of the test is 30 minutes, according to the Indonesian Pharmacopoeia.

How is the tablet placed in the dissolution apparatus?

The tablet is carefully placed in the chamber containing the medium without touching the bottom, and the chamber is then covered and secured before starting the test.

How are samples collected during the dissolution test?

Samples of 5 mL are taken at specific intervals (0, 5, 10, 15, 20, 25, and 30 minutes) using a syringe and transferred into a separate container for analysis.

What method is used to measure the concentration of Amoxicillin in the samples?

High-Performance Liquid Chromatography (HPLC) is used to determine the concentration of Amoxicillin in the samples, following the Indonesian Pharmacopoeia method.

How is the calibration curve used in the analysis?

The calibration curve relates the HPLC detector area (y) to the known concentrations of Amoxicillin (x), using the regression equation y = AX + b. This allows calculation of the drug concentration in each sample.

How is the amount of drug in milligrams calculated from the concentration?

The concentration in μg/mL is multiplied by the dissolution volume (900 mL) to get the total drug amount in μg, which is then converted to milligrams.

What is the purpose of the correction factor in the calculations?

The correction factor accounts for the volume of the sample removed at each interval and ensures that the cumulative drug amount represents the total drug dissolved over time.

How is the percentage of drug dissolved calculated?

The percentage dissolved is calculated as the corrected drug amount (in mg) divided by the labeled tablet strength (500 mg) multiplied by 100%.

What were the results of the dissolution test for Amoxicillin 500 mg tablets?

The percentages of Amoxicillin dissolved at 5, 10, 15, and 30 minutes were 51.65%, 58.96%, 61.07%, and 93.45%, respectively.

Did the Amoxicillin tablets meet the dissolution criteria according to the Indonesian Pharmacopoeia?

Yes, the tablets met the criteria because at least 75% of the drug dissolved within 30 minutes, and the test showed 93.45% dissolution at 30 minutes.