Determination of Betamethasone Levels

Oct 13, 2025 by windailys.com 5 views

Introduction

Betamethasone cream 0.1% is a widely used topical corticosteroid that is effective in treating various skin allergies and inflammatory conditions. The quality of this cream is crucial in ensuring its effectiveness and safety for public use. In this study, we evaluated the quality of betamethasone cream 0.1% produced by PT Kimia Farma (Persero) Tbk. using high performance liquid chromatography (HPLC) methods, pH measurements, and analysis of uniformity of weight.

Methodology

The study involved two samples of betamethasone cream 0.1% produced by PT Kimia Farma (Persero) Tbk., namely Batch 0280791 (sample A) and Batch 0280801 (sample B). The evaluation process included:

Determination of Betamethasone Levels: HPLC methods were used to determine the levels of betamethasone in both samples.
pH Measurements: pH meters were used to measure the pH values of both samples.
Analysis of Uniformity of Weight: Digital scales were used to analyze the uniformity of weight of both samples.

Results

The results of the evaluation are presented in the following table:

Sample	Betamethasone Level (%)	pH Value	Uniformity of Weight (g)	Standard Deviation (%)
A	104.47	6.87	5.02	0.06
B	103.83	6.72	5.05	0.09

Discussion

The results of the evaluation show that both samples of betamethasone cream 0.1% meet the requirements set in the Indonesian Pharmacope IV. The betamethasone levels in both samples are above 100%, indicating that the production of this cream is consistent with the standardized standard value. The pH values of both samples are within the normal range (between 6 to 7), indicating that the cream will not cause irritation to the skin when used. The uniformity of weight of both samples is also good, indicating that every product packaging has consistency in terms of content.

Conclusion

This study demonstrates the commitment of PT Kimia Farma (Persero) Tbk. to high quality standards in drug production. The results of the evaluation show that the betamethasone cream 0.1% produced by the company meets the requirements set in the Indonesian Pharmacope IV. This not only has a positive impact on the company itself, but also gives consumer confidence in the safety and effectiveness of the products they use. It is hoped that similar research can continue to ensure that all pharmaceutical products on the market meet strict quality criteria.

Recommendations

Based on the results of this study, the following recommendations are made:

Continued Quality Control: PT Kimia Farma (Persero) Tbk. should continue to conduct regular quality control checks on its products to ensure that they meet the required standards.
Improvement of Production Process: The company should consider improving its production process to ensure that the quality of its products is consistently high.
Training and Education: The company should provide training and education to its employees on the importance of quality control and the procedures for conducting quality checks.

Limitations of the Study

This study has several limitations, including:

Small Sample Size: The study only involved two samples of betamethasone cream 0.1%, which may not be representative of the entire production batch.
Limited Evaluation Parameters: The study only evaluated the betamethasone levels, pH values, and uniformity of weight of the samples, which may not be comprehensive enough to fully evaluate the quality of the product.

Future Research Directions

Future research should focus on:

Expanding the Evaluation Parameters: Future studies should evaluate a wider range of parameters, such as the presence of impurities and the stability of the product.
Increasing the Sample Size: Future studies should involve a larger sample size to ensure that the results are representative of the entire production batch.
Comparing with Other Products: Future studies should compare the quality of betamethasone cream 0.1% produced by PT Kimia Farma (Persero) Tbk. with other similar products on the market.

Q: What is betamethasone cream 0.1%?

A: Betamethasone cream 0.1% is a topical corticosteroid that is effective in treating various skin allergies and inflammatory conditions.

Q: What is the purpose of this study?

A: The purpose of this study is to evaluate the quality of betamethasone cream 0.1% produced by PT Kimia Farma (Persero) Tbk. using high performance liquid chromatography (HPLC) methods, pH measurements, and analysis of uniformity of weight.

Q: What are the evaluation parameters used in this study?

A: The evaluation parameters used in this study include:

Determination of Betamethasone Levels: HPLC methods were used to determine the levels of betamethasone in both samples.
pH Measurements: pH meters were used to measure the pH values of both samples.
Analysis of Uniformity of Weight: Digital scales were used to analyze the uniformity of weight of both samples.

Q: What are the results of the evaluation?

A: The results of the evaluation show that both samples of betamethasone cream 0.1% meet the requirements set in the Indonesian Pharmacope IV. The betamethasone levels in both samples are above 100%, indicating that the production of this cream is consistent with the standardized standard value. The pH values of both samples are within the normal range (between 6 to 7), indicating that the cream will not cause irritation to the skin when used. The uniformity of weight of both samples is also good, indicating that every product packaging has consistency in terms of content.

Q: What are the implications of this study?

A: The results of this study demonstrate the commitment of PT Kimia Farma (Persero) Tbk. to high quality standards in drug production. The study shows that the betamethasone cream 0.1% produced by the company meets the requirements set in the Indonesian Pharmacope IV, which gives consumer confidence in the safety and effectiveness of the products they use.

Q: What are the limitations of this study?

A: This study has several limitations, including:

Small Sample Size: The study only involved two samples of betamethasone cream 0.1%, which may not be representative of the entire production batch.
Limited Evaluation Parameters: The study only evaluated the betamethasone levels, pH values, and uniformity of weight of the samples, which may not be comprehensive enough to fully evaluate the quality of the product.

Q: What are the recommendations for future research?

A: Future research should focus on:

Expanding the Evaluation Parameters: Future studies should evaluate a wider range of parameters, such as the presence of impurities and the stability of the product.
Increasing the Sample Size: Future studies should involve a larger sample size to ensure that the results are representative of the entire production batch.
Comparing with Other Products: Future studies should compare the quality of betamethasone cream 0.1% produced by PT Kimia Farma (Persero) Tbk. with other similar products on the market.

Q: What are the implications for consumers?

A: The results of this study demonstrate that the betamethasone cream 0.1% produced by PT Kimia Farma (Persero) Tbk. meets the requirements set in the Indonesian Pharmacope IV, which gives consumers confidence in the safety and effectiveness of the products they use.

Q: What are the implications for the company?

A: The results of this study demonstrate the commitment of PT Kimia Farma (Persero) Tbk. to high quality standards in drug production, which can improve the company's reputation and increase consumer confidence in its products.

Q: What are the implications for the industry?

A: The results of this study demonstrate the importance of quality control in the pharmaceutical industry, which can improve the overall quality of products and increase consumer confidence in the industry as a whole.