The Importance of Quality Control in Pharmaceutical Preparations

Oct 13, 2025 by windailys.com 73 views

Determining Metronidazole Levels in Tablet Preparations with Trade Names and Generics by Spectrophotometry of Fourier Transform Infra Red (FTIR)

Introduction

Metronidazole: A Broad-Spectrum Antibiotic with a Rich History

Metronidazole is a nitro-imidazole compound that has been widely used to treat various bacterial and protozoal infections since its discovery in 1959. This antibiotic has been instrumental in treating trichomoniasis, a sexually transmitted infection caused by the protozoan parasite Trichomonas vaginalis. The importance of testing the quality of drug preparations cannot be overstated, as it ensures that each preparation meets the standards set by the 2014 Indonesian Pharmacopoeia. In this context, this study aims to determine the metronidazole levels in various tablet preparations, both those with trade names and generics, as well as to evaluate the suitability of these levels in accordance with applicable requirements.

The Importance of Quality Control in Pharmaceutical Preparations

Quality Control: A Guarantee of Safety and Effectiveness

The quality of pharmaceutical preparations is a critical factor in ensuring the safety and effectiveness of medications. With the increasing number of pharmaceutical products available in the market, it is essential to have a reliable method for testing the quality of these products. The 2014 Indonesian Pharmacopoeia sets the standards for the quality of pharmaceutical preparations, including metronidazole tablets. In this study, we aim to determine the metronidazole levels in various tablet preparations and evaluate the suitability of these levels in accordance with the standards set by the 2014 Indonesian Pharmacopoeia.

Methodology

Spectrophotometry of Fourier Transform Infrared (FTIR): A Reliable Analytical Technique

The method used in this study is a spectrophotometry of Fourier Transform Infrared (FTIR), which utilizes methanol solvents in the waveform range of 4000-650 cm-1. The FTIR method is one of the analytical techniques that is very effective in determining the chemical composition and concentration of drugs. This method is widely used in the pharmaceutical industry due to its accuracy, reliability, and speed.

Results

Metronidazole Levels in Tablet Preparations: A Comparative Study

The results of this study showed that metronidazole levels in tablet preparations have a variety of ranges. The metronidazole levels in Grafazol, MetroLet, Omenizol, and Trichodazol tablets were found to be 101.66 ± 0.20%, 97.98 ± 0.16%, 98.87 ± 0.13%, and 98.87 ± 0.13%, respectively. These results indicate that the metronidazole levels in these tablet preparations are within the acceptable range.

Validation of the Method

Validation of the FTIR Method: A Crucial Step in Ensuring Accuracy and Reliability

The validation of the method used in this study shows quite promising results. The recovery test reached 99.87%, with a relative standard deviation (RSD) of 0.25%. The detection limit (LOD) and the quantification limit (LOQ) are set at 3,5819 mg/ml and 11,9397 mg/ml, respectively. These results confirm that the method applied in this study is accurate and reliable.

Conclusion

Conclusion: FTIR Method is an Effective Way to Determine Metronidazole Levels

From the overall results obtained, it can be concluded that the spectrophotometry method of Fourier Transform Infrared (FTIR) is an effective way to determine the level of metronidazole in tablet preparations. Metronidazole levels in the preparation that are tested also meet the standards set by the 2014 Indonesian Pharmacopoeia, which ultimately provides quality assurance for consumers.

Recommendations for Further Research

Further Research: A Step Towards Ensuring the Quality of Pharmaceutical Products

Further steps that need to be considered are the development of further research that can include the application of this method in various other forms of preparation as well as the analysis of strengths and weaknesses of the method, so as to increase our understanding of controlling drug quality in Indonesia. This is important to ensure that pharmaceutical products circulating are safe and effective for the wider community.

References

Indonesian Pharmacopoeia (2014)
Metronidazole: A Review of its Use in the Treatment of Bacterial and Protozoal Infections (2019)
Spectrophotometry of Fourier Transform Infrared (FTIR): A Review of its Applications in the Pharmaceutical Industry (2020)

Appendix

Table 1: Metronidazole levels in tablet preparations
Table 2: Validation of the FTIR method
Figure 1: FTIR spectrum of metronidazole
Figure 2: Metronidazole levels in tablet preparations
Frequently Asked Questions (FAQs) about Determining Metronidazole Levels in Tablet Preparations with Trade Names and Generics by Spectrophotometry of Fourier Transform Infra Red (FTIR)

Q: What is metronidazole and why is it important to determine its levels in tablet preparations?

A: Metronidazole is a nitro-imidazole compound that has been widely used to treat various bacterial and protozoal infections. Determining its levels in tablet preparations is crucial to ensure the quality and safety of the medication.

Q: What is the significance of the 2014 Indonesian Pharmacopoeia in determining metronidazole levels?

A: The 2014 Indonesian Pharmacopoeia sets the standards for the quality of pharmaceutical preparations, including metronidazole tablets. Determining metronidazole levels in accordance with these standards ensures that the medication meets the required quality and safety standards.

Q: What is spectrophotometry of Fourier Transform Infrared (FTIR) and how is it used to determine metronidazole levels?

A: Spectrophotometry of Fourier Transform Infrared (FTIR) is an analytical technique that uses infrared radiation to determine the chemical composition and concentration of a substance. In this study, FTIR is used to determine the metronidazole levels in tablet preparations.

Q: What are the advantages of using FTIR in determining metronidazole levels?

A: FTIR is a reliable and accurate analytical technique that provides quick results. It is also non-destructive, meaning that the sample is not damaged during the analysis process.

Q: What are the limitations of the FTIR method in determining metronidazole levels?

A: While FTIR is a reliable analytical technique, it may not be suitable for all types of samples. Additionally, the method requires specialized equipment and expertise to operate.

Q: What are the implications of the study's findings on the quality and safety of metronidazole tablets?

A: The study's findings suggest that the metronidazole levels in tablet preparations are within the acceptable range, indicating that the medication meets the required quality and safety standards.

Q: What are the recommendations for further research in determining metronidazole levels?

A: Further research is needed to apply the FTIR method to various other forms of preparation and to analyze the strengths and weaknesses of the method. This will help to increase our understanding of controlling drug quality in Indonesia.

Q: What are the potential applications of the FTIR method in determining metronidazole levels?

A: The FTIR method can be applied to determine the levels of other pharmaceutical compounds, making it a valuable tool in the pharmaceutical industry.

Q: What are the potential risks associated with using metronidazole tablets?

A: Metronidazole tablets can cause side effects such as nausea, vomiting, and diarrhea. Additionally, the medication can interact with other medications, increasing the risk of adverse reactions.

Q: How can consumers ensure the quality and safety of metronidazole tablets?

A: Consumers can ensure the quality and safety of metronidazole tablets by purchasing from reputable pharmacies and following the recommended dosage instructions.

Q: What are the future directions for research in determining metronidazole levels?

A: Future research should focus on applying the FTIR method to various other forms of preparation and analyzing the strengths and weaknesses of the method. Additionally, research should be conducted to develop new analytical techniques for determining metronidazole levels.

Q: What are the potential benefits of using FTIR in determining metronidazole levels?

A: The use of FTIR in determining metronidazole levels can provide quick and accurate results, reducing the time and cost associated with traditional analytical techniques. Additionally, FTIR can be used to determine the levels of other pharmaceutical compounds, making it a valuable tool in the pharmaceutical industry.