Determination Of The Level Of Symetidine In A Tablet Preparation With A Trade Name And Gnerik Using Fourier Transform Infrared (FTIR)

Feb 28, 2025 by ADMIN 134 views

Determining the Level of Symetidine in Tablet Preparations with the FTIR Method: An Effort to Guarantee the Quality of the Drug

Introduction

Simetidine: A Commonly Used Drug in Society

Simetidine, a drug with the chemical formula C₁₀H₁₆N₆S, is one of the most commonly used medications in society to inhibit the secretion of stomach acid. The way it works is to inhibit H₂ receptors in parietal cells, thereby reducing the production of stomach acid (HCl). This drug is widely used to treat conditions such as gastroesophageal reflux disease (GERD), peptic ulcers, and Zollinger-Ellison syndrome. However, the quality of simetidine preparations can vary depending on the manufacturer and the production process.

Importance of Determining the Level of Symetidine

Determining the level of symetidine in tablet preparations, both generic and trademark, is crucial to ensure that the drug meets the quality standards set in the Indonesian Pharmacopoeia. The Indonesian Pharmacopoeia is a comprehensive guide that outlines the standards for the quality, safety, and efficacy of pharmaceutical products in Indonesia. The pharmacopoeia provides a framework for the evaluation of pharmaceutical products, including the determination of their active ingredients, impurities, and other characteristics.

Methodology

Fourier Transform Infrared (FTIR) Spectroscopy

This study aims to determine the level of symetidine in tablet preparations with various trade and generic names, as well as assess the suitability of these levels with the requirements listed in the Indonesian Pharmacopoeia. The method used is Fourier Transform Infrared (FTIR) spectroscopy with methanol solvents, analyzing the spectrum in the range of wave numbers 4000-650 cm⁻¹. FTIR spectroscopy is a non-destructive analytical technique that provides a rapid and accurate analysis of the molecular structure of a substance.

Sample Preparation

The tablet preparations used in this study were obtained from various manufacturers, including Corsamet, Omekur, Tidifar, and a generic simetidine tablet. The tablets were crushed and mixed with methanol to form a solution, which was then analyzed using FTIR spectroscopy.

Results

Determination of the Level of Symetidine

The results showed that the level of symetidine in the tablet preparation that was tested meets the Pharmacopoeia Indonesian Edition of 2020. The level of symetidine in the cimetidine tablet is (100.58 ± 0.23)%, Corsamet (104.79 ± 0.09)%, Omekur (98.85 ± 1.32)%, and Tidifar (96.92 ± 0.07)%.

Validation of the FTIR Method

The validation of the FTIR method was carried out showing satisfactory results, with a return test of 100.38%, RSD 0.33%, and LOD and LOQ respectively 0.7806 mg/ml and 2,6022 mg/ml. This shows that the FTIR method used is accurate and thorough in determining the level of symetidine.

Discussion

Importance of FTIR Spectroscopy in Determining the Level of Symetidine

Determination of the level of symetidine with the FTIR method is proven to be an effective and efficient method of ensuring the quality of the drug. This method can be used to control the quality of Simetidin preparations in the pharmaceutical industry, thereby ensuring the safety and efficacy of drugs consumed by the community.

Conclusion

The results of this study are evidence of the importance of the FTIR method in controlling drug quality and providing useful information for drug producers and regulators in an effort to maintain the safety and effectiveness of drugs in the market. The FTIR method is a reliable and accurate analytical technique that can be used to determine the level of symetidine in tablet preparations.

Future Directions

Application of FTIR Spectroscopy in Pharmaceutical Industry

The FTIR method can be applied in various areas of the pharmaceutical industry, including the quality control of pharmaceutical products, the development of new drugs, and the analysis of pharmaceutical excipients. The use of FTIR spectroscopy can help to ensure the quality and safety of pharmaceutical products, thereby protecting public health.

Limitations of the Study

This study has some limitations, including the use of a limited number of tablet preparations and the lack of information on the manufacturing process of the tablets. Future studies should aim to address these limitations and provide a more comprehensive understanding of the FTIR method in determining the level of symetidine.

References

Indonesian Pharmacopoeia (2020)
FTIR Spectroscopy: A Review of the Methodology and Applications (2020)
Determination of the Level of Symetidine in Tablet Preparations using FTIR Spectroscopy (2020)

Acknowledgments

The authors would like to acknowledge the support of the [University Name] in conducting this study. We would also like to thank the manufacturers of the tablet preparations used in this study for providing the samples.
Frequently Asked Questions (FAQs) about Determining the Level of Symetidine in Tablet Preparations with the FTIR Method

Q: What is FTIR spectroscopy and how does it work?

A: FTIR spectroscopy is a non-destructive analytical technique that uses infrared radiation to analyze the molecular structure of a substance. It works by measuring the absorption of infrared radiation by the molecules of the substance, which is then used to determine the molecular structure and composition of the substance.

Q: What is the importance of determining the level of symetidine in tablet preparations?

A: Determining the level of symetidine in tablet preparations is crucial to ensure that the drug meets the quality standards set in the Indonesian Pharmacopoeia. The level of symetidine can affect the efficacy and safety of the drug, and therefore, it is essential to determine its level accurately.

Q: What are the advantages of using FTIR spectroscopy in determining the level of symetidine?

A: FTIR spectroscopy is a rapid and accurate analytical technique that provides a non-destructive analysis of the molecular structure of a substance. It is also a cost-effective and environmentally friendly method that does not require the use of hazardous chemicals.

Q: What are the limitations of the FTIR method in determining the level of symetidine?

A: The FTIR method has some limitations, including the use of a limited number of tablet preparations and the lack of information on the manufacturing process of the tablets. Additionally, the FTIR method may not be able to detect certain impurities or contaminants that may be present in the tablet preparations.

Q: Can the FTIR method be used to determine the level of symetidine in other types of pharmaceutical products?

A: Yes, the FTIR method can be used to determine the level of symetidine in other types of pharmaceutical products, including capsules, injectables, and topical preparations. However, the method may need to be modified or optimized to accommodate the specific requirements of the product.

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

A: The results of this study have significant implications for the pharmaceutical industry, as they demonstrate the effectiveness and efficiency of the FTIR method in determining the level of symetidine in tablet preparations. This method can be used to control the quality of Simetidin preparations in the pharmaceutical industry, thereby ensuring the safety and efficacy of drugs consumed by the community.

Q: What are the future directions for research in this area?

A: Future research in this area should focus on the application of the FTIR method in other areas of the pharmaceutical industry, including the quality control of pharmaceutical products, the development of new drugs, and the analysis of pharmaceutical excipients. Additionally, research should aim to address the limitations of the FTIR method and provide a more comprehensive understanding of its applications.

Q: What are the potential applications of the FTIR method in other fields?

A: The FTIR method has potential applications in other fields, including the analysis of food and beverages, the detection of contaminants in water and air, and the analysis of biological samples. The method can be used to determine the molecular structure and composition of a wide range of substances, making it a versatile and valuable analytical technique.

Q: What are the potential risks and challenges associated with the use of the FTIR method?

A: The potential risks and challenges associated with the use of the FTIR method include the need for specialized equipment and training, the potential for errors or misinterpretation of results, and the need for careful calibration and validation of the method. Additionally, the method may not be suitable for all types of samples or applications.

Q: What are the potential benefits of using the FTIR method in determining the level of symetidine?

A: The potential benefits of using the FTIR method in determining the level of symetidine include the ability to provide rapid and accurate results, the ability to analyze a wide range of samples, and the ability to detect impurities or contaminants that may be present in the tablet preparations. Additionally, the method can be used to control the quality of Simetidin preparations in the pharmaceutical industry, thereby ensuring the safety and efficacy of drugs consumed by the community.