The Importance of Quality Control in Pharmaceutical Production

Oct 13, 2025 by miodeya.com 65 views

Determining the Quality of Chloroquine Phosphate Tablets: A Study on UV-Visible Spectrophotometry

Introduction

The quality of pharmaceutical products is a crucial aspect of ensuring the safety and effectiveness of medications. In the production of chloroquine phosphate tablets, quality control is essential to guarantee that the final product meets the required standards. This study aims to determine the levels of chloroquine phosphate in chloroquine phosphate tablets 250 mg using the UV-Visible spectrophotometry method, produced by PT. Mutiara Mukti Farma. The results of this analysis will provide valuable insights into the quality of the product and the importance of quality control in the pharmaceutical industry.

The Importance of Quality Control in Pharmaceutical Production

Quality control is a critical aspect of pharmaceutical production, focusing not only on efficiency but also on the safety and effectiveness of drugs. The pharmaceutical industry relies heavily on quality control measures to ensure that each product batch meets the established standards. This is particularly important in the production of chloroquine phosphate tablets, as the medication is used to treat various diseases, including malaria and autoimmune diseases.

The UV-Visible Spectrophotometry Method

The UV-Visible spectrophotometry method is a widely used analysis technique for determining the concentration of chemicals in a solution. This method is based on the relationship between absorbance and concentration, as expressed in the law of Lambert-Beer. By measuring the absorbance of chloroquine phosphate at a specific wavelength, the concentration of the compound in a tablet can be calculated.

Analysis of Chloroquine Phosphate Levels

The analysis of chloroquine phosphate levels in chloroquine phosphate tablets 250 mg was carried out using the UV-Visible spectrophotometry method. The results of the analysis showed that the level of phosphate chloroquine detected was 94.54%, which is equivalent to 236.34 mg per tablet. This finding meets the standards set in the 2014 Edition V Pharmacopoeia, which requires that the chloroquine phosphate levels in tablets should be no less than 93.0% and no more than 107.0%.

Relevance of the Results of the Analysis

The results of the analysis showing the chloroquine phosphate level of 94.54% are very important to ensure the quality and safety of the product produced. This level shows that the tablet produced by PT. Mutiara Mukti Farma has a good consistency in meeting the regulated specifications. Obeying the limits set by Pharmacopoeia ensures that the patient receives an effective and safe dose, which in turn can contribute to the control of diseases that require chloroquine as therapy.

The Importance of UV-Visible Spectrophotometry in Quality Control

The UV-Visible spectrophotometry method is a fast and accurate testing technique used in the pharmaceutical industry to ensure that each product batch meets the established standards. This method plays an important role in building consumer trust in the products they consume. By using this method, the pharmaceutical industry can conduct quality control testing quickly and accurately, ensuring that the final product is safe and effective.

Conclusion

The analysis of chloroquine phosphate levels in chloroquine phosphate tablets 250 mg through the UV-Visible spectrophotometry method shows positive results and meets the requirements set by Pharmacopoeia. This study underlines the importance of quality testing in the pharmaceutical industry and how modern analysis techniques can be applied to ensure safe and effective products. With this understanding, it is expected that both producers and consumers will better appreciate the quality control process in producing drugs.

Recommendations

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

The pharmaceutical industry should continue to use the UV-Visible spectrophotometry method as a quality control technique to ensure the safety and effectiveness of drugs.
Producers should ensure that each product batch meets the established standards, and that the quality control process is transparent and reliable.
Consumers should be aware of the importance of quality control in pharmaceutical production and should demand high-quality products from producers.

Future Directions

Future studies should focus on the application of other modern analysis techniques, such as high-performance liquid chromatography (HPLC) and gas chromatography (GC), to ensure the quality and safety of pharmaceutical products. Additionally, studies should investigate the use of alternative methods for quality control, such as near-infrared spectroscopy (NIR) and Raman spectroscopy.

Limitations of the Study

This study has several limitations, including:

The use of a single analysis technique, UV-Visible spectrophotometry, which may not be sufficient to ensure the quality and safety of the product.
The limited sample size, which may not be representative of the entire product batch.
The lack of comparison with other analysis techniques, which may not be the most accurate or reliable method.

Conclusion

In conclusion, this study demonstrates the importance of quality control in pharmaceutical production and the use of modern analysis techniques, such as UV-Visible spectrophotometry, to ensure the safety and effectiveness of drugs. The results of this study show that the chloroquine phosphate levels in chloroquine phosphate tablets 250 mg meet the requirements set by Pharmacopoeia. This study highlights the need for further research in the application of alternative analysis techniques and the importance of quality control in pharmaceutical production.
Frequently Asked Questions (FAQs) on Determining Chloroquine Phosphate Levels in Chloroquine Phosphate Tablets 250 mg

Q: What is the purpose of determining chloroquine phosphate levels in chloroquine phosphate tablets 250 mg?

A: The purpose of determining chloroquine phosphate levels in chloroquine phosphate tablets 250 mg is to ensure the quality and safety of the product. This is crucial in pharmaceutical production, as the medication is used to treat various diseases, including malaria and autoimmune diseases.

Q: What is the UV-Visible spectrophotometry method, and how is it used in determining chloroquine phosphate levels?

A: The UV-Visible spectrophotometry method is a widely used analysis technique for determining the concentration of chemicals in a solution. This method is based on the relationship between absorbance and concentration, as expressed in the law of Lambert-Beer. By measuring the absorbance of chloroquine phosphate at a specific wavelength, the concentration of the compound in a tablet can be calculated.

Q: What are the standards set by Pharmacopoeia for chloroquine phosphate levels in tablets?

A: The standards set by Pharmacopoeia for chloroquine phosphate levels in tablets require that the levels should be no less than 93.0% and no more than 107.0%.

Q: What are the implications of the results of the analysis showing the chloroquine phosphate level of 94.54%?

A: The results of the analysis showing the chloroquine phosphate level of 94.54% are very important to ensure the quality and safety of the product produced. This level shows that the tablet produced by PT. Mutiara Mukti Farma has a good consistency in meeting the regulated specifications.

Q: What is the importance of quality control in pharmaceutical production?

A: Quality control is an important aspect of pharmaceutical production, focusing not only on efficiency but also on the safety and effectiveness of drugs. The pharmaceutical industry relies heavily on quality control measures to ensure that each product batch meets the established standards.

Q: What are the benefits of using the UV-Visible spectrophotometry method in quality control?

A: The UV-Visible spectrophotometry method is a fast and accurate testing technique used in the pharmaceutical industry to ensure that each product batch meets the established standards. This method plays an important role in building consumer trust in the products they consume.

Q: What are the limitations of the study?

A: This study has several limitations, including:

The use of a single analysis technique, UV-Visible spectrophotometry, which may not be sufficient to ensure the quality and safety of the product.
The limited sample size, which may not be representative of the entire product batch.
The lack of comparison with other analysis techniques, which may not be the most accurate or reliable method.

Q: What are the future directions for this study?

A: Future studies should focus on the application of other modern analysis techniques, such as high-performance liquid chromatography (HPLC) and gas chromatography (GC), to ensure the quality and safety of pharmaceutical products. Additionally, studies should investigate the use of alternative methods for quality control, such as near-infrared spectroscopy (NIR) and Raman spectroscopy.

Q: What are the recommendations for producers and consumers?

A: Producers should ensure that each product batch meets the established standards, and that the quality control process is transparent and reliable. Consumers should be aware of the importance of quality control in pharmaceutical production and should demand high-quality products from producers.

Q: What are the implications of this study for the pharmaceutical industry?

A: This study highlights the importance of quality control in pharmaceutical production and the use of modern analysis techniques, such as UV-Visible spectrophotometry, to ensure the safety and effectiveness of drugs. The results of this study show that the chloroquine phosphate levels in chloroquine phosphate tablets 250 mg meet the requirements set by Pharmacopoeia. This study underlines the need for further research in the application of alternative analysis techniques and the importance of quality control in pharmaceutical production.