Importance of Examining Active Substance Levels in Drug Preparations

Oct 13, 2025 by windailys.com 10 views

Introduction to Antalgin: A Non-Steroid Analgesic Drug (NSAID)

Antalgin, also known as Generic Methampyron or Metamizole, is a non-steroid analgesic drug (NSAID) which has a variety of functions, such as analgesic, anti-inflammatory, and antipyretic. As a widely used medication, Antalgin plays a crucial role in relieving pain and reducing high body temperature, making it an essential component in various medical treatments. In addition, the anti-inflammatory properties of Antalgin are useful in overcoming inflammation that occurs in the body.

Importance of Examining Active Substance Levels in Drug Preparations

To ensure the quality of drug preparations, one of the important steps that must be taken is an examination of active substance levels. This examination is crucial in ensuring the efficacy and safety of the medication, as well as preventing any potential harm to the users. The quality control process involves various methods, including spectrophotometry, to determine the levels of active substances in drug preparations.

Spectrophotometry of Fourier Transform Infra Red (FTIR): A Device for Analyzing Molecular Vibration Spectrum

FTIR is a device used to analyze the molecular vibration spectrum that can help in the prediction of the structure of chemical compounds. The specialty of the IR spectrum is its ability to provide complete information about functional groups in a molecule, including interactions between these groups, as well as providing specific fingerprint information for each molecule. This makes FTIR an essential tool in various fields, including pharmaceuticals, chemistry, and materials science.

Purpose and Methodology of the Study

The purpose of this study is to determine the levels of Antalgin in various tablet preparations both labeled trade names and generics, as well as to evaluate the suitability of these levels of the requirements set in the Indonesian Pharmacopoeia. The method used in this study includes testing Antalgin levels with methanol solvents in a wave range of 4000-650 cm^-1. This method allows for the accurate determination of Antalgin levels in various tablet preparations.

Results of the Study

_The results of the study showed that the Antalgin levels in several tablet preparations, namely the Unigin® tablet (103.55 ± 0.11)%, Novalgin® tablets (100.61 ± 0.16)%, Tablet Antrain® (95.94 ± 0, 15)%, Tablet Selesgin® (101.85 ± 0.11)%, Antalgin Kimia Farma Tablet (100.12 ± 0.11)%, and Corsa Antalgin Tablet (97.42 ± 0.05)%. All levels obtained meet the standards set in Pharmacopoeia IV IV in 1995, where the Antalgin levels must be not less than 99.0% and no more than 101.0% of the amount listed on the label. This indicates that the Antalgin levels in these tablet preparations are within the acceptable range, ensuring their safety and efficacy for use by the community.

Validation of the Method

_The validation of the method shows the recovery results of 100.14%, with the RSD (Relative Standard Deviation) value of 0.83%. In addition, the value of the Limit of Detection (LOD) and the Limit of Quantitation (LOQ) are obtained at 4,6615 mg/ml and 15,5383 mg/ml. These results confirm that the method used in this study provides accurate and reliable results, making it a suitable method for determining Antalgin levels in tablet preparations.

Conclusion

The conclusion of this study is that the determination of Antalgin levels in tablet preparations can be done using a spectrophotometry of Fourier Transform Infra Red (FTIR). In addition, the Antalgin levels in various tablet preparations studied have met the requirements in the IV IV Pharmacopoeia in 1995, so it can be ascertained that these preparations are safe and effective for use by the community. This study highlights the importance of quality control in pharmaceuticals and the use of FTIR in determining active substance levels in drug preparations.

Recommendations

Based on the results of this study, it is recommended that the use of FTIR in determining Antalgin levels in tablet preparations be continued and expanded to other pharmaceutical applications. In addition, further studies should be conducted to evaluate the suitability of FTIR in determining the levels of other active substances in drug preparations. This will help in ensuring the quality and safety of pharmaceutical products, ultimately benefiting the community.

Limitations of the Study

The limitations of this study include the use of a single method (FTIR) for determining Antalgin levels, as well as the limited number of tablet preparations studied. Future studies should aim to overcome these limitations by using multiple methods and a larger number of tablet preparations. This will provide a more comprehensive understanding of the Antalgin levels in various tablet preparations and ensure the accuracy and reliability of the results.

Future Directions

The results of this study have implications for the pharmaceutical industry, highlighting the importance of quality control in ensuring the safety and efficacy of pharmaceutical products. Future studies should aim to evaluate the suitability of FTIR in determining the levels of other active substances in drug preparations, as well as exploring its applications in other fields, such as materials science and chemistry. This will help in advancing our understanding of the properties and behavior of various substances, ultimately benefiting society.

Conclusion

In conclusion, this study demonstrates the effectiveness of FTIR in determining Antalgin levels in tablet preparations. The results of this study have significant implications for the pharmaceutical industry, highlighting the importance of quality control in ensuring the safety and efficacy of pharmaceutical products. This study provides a valuable contribution to the field of pharmaceuticals, ultimately benefiting the community.

Q: What is Antalgin and what are its functions?

A: Antalgin, also known as Generic Methampyron or Metamizole, is a non-steroid analgesic drug (NSAID) which has a variety of functions, such as analgesic, anti-inflammatory, and antipyretic. It is used to relieve pain and reduce high body temperature, as well as to overcome inflammation that occurs in the body.

Q: Why is it important to examine active substance levels in drug preparations?

A: Examining active substance levels in drug preparations is crucial in ensuring the efficacy and safety of the medication, as well as preventing any potential harm to the users. This examination is an essential step in the quality control process of pharmaceutical products.

Q: What is FTIR and how does it work?

A: FTIR is a device used to analyze the molecular vibration spectrum that can help in the prediction of the structure of chemical compounds. It provides complete information about functional groups in a molecule, including interactions between these groups, as well as providing specific fingerprint information for each molecule.

Q: What is the purpose of this study and what method was used?

A: The purpose of this study is to determine the levels of Antalgin in various tablet preparations both labeled trade names and generics, as well as to evaluate the suitability of these levels of the requirements set in the Indonesian Pharmacopoeia. The method used in this study includes testing Antalgin levels with methanol solvents in a wave range of 4000-650 cm^-1.

Q: What were the results of the study and did they meet the standards set in the Pharmacopoeia?

A: The results of the study showed that the Antalgin levels in several tablet preparations met the standards set in the Pharmacopoeia IV IV in 1995, where the Antalgin levels must be not less than 99.0% and no more than 101.0% of the amount listed on the label. This indicates that the Antalgin levels in these tablet preparations are within the acceptable range, ensuring their safety and efficacy for use by the community.

Q: What is the validation of the method and what were the results?

A: The validation of the method shows the recovery results of 100.14%, with the RSD (Relative Standard Deviation) value of 0.83%. In addition, the value of the Limit of Detection (LOD) and the Limit of Quantitation (LOQ) are obtained at 4,6615 mg/ml and 15,5383 mg/ml. These results confirm that the method used in this study provides accurate and reliable results.

Q: What are the implications of this study and what are the recommendations?

A: The results of this study have significant implications for the pharmaceutical industry, highlighting the importance of quality control in ensuring the safety and efficacy of pharmaceutical products. It is recommended that the use of FTIR in determining Antalgin levels in tablet preparations be continued and expanded to other pharmaceutical applications.

Q: What are the limitations of this study and what are the future directions?

A: The limitations of this study include the use of a single method (FTIR) for determining Antalgin levels, as well as the limited number of tablet preparations studied. Future studies should aim to overcome these limitations by using multiple methods and a larger number of tablet preparations. This will provide a more comprehensive understanding of the Antalgin levels in various tablet preparations and ensure the accuracy and reliability of the results.

Q: What are the future directions of this study and how can it benefit society?

A: The results of this study have implications for the pharmaceutical industry, highlighting the importance of quality control in ensuring the safety and efficacy of pharmaceutical products. Future studies should aim to evaluate the suitability of FTIR in determining the levels of other active substances in drug preparations, as well as exploring its applications in other fields, such as materials science and chemistry. This will help in advancing our understanding of the properties and behavior of various substances, ultimately benefiting society.