Stability study of niclosamide using spectroscopy and chromatography.
Journal name: World Journal of Pharmaceutical Research
Original article title: Stability studies on niclosamide using derivative spectroscopic and chromatographic methods
The WJPR includes peer-reviewed publications such as scientific research papers, reports, review articles, company news, thesis reports and case studies in areas of Biology, Pharmaceutical industries and Chemical technology while incorporating ancient fields of knowledge such combining Ayurveda with scientific data.
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Shaza Wagiealla Shantier, Elrashied Ali Elobaid, Elrasheed Ahmed Gadkariem
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: Stability studies on niclosamide using derivative spectroscopic and chromatographic methods
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
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Summary of article contents:
Introduction
The study by Shaza Wagiealla Shantier and colleagues focuses on the stability of niclosamide, an effective anthelmintic drug, using various analytical methods including first derivative spectrophotometry, high-performance liquid chromatography (HPLC), and thin-layer chromatography (TLC). The research aims to investigate how factors such as pH, temperature, alkalinity, and light exposure affect the degradation of niclosamide, with a particular emphasis on developing stability-indicating methodologies for monitoring these effects.
Impact of pH on Degradation
One of the key findings of the study is the significant effect of pH on the degradation of niclosamide. As the pH of the solution increases, the rate of hydrolysis also rises, particularly when the pH exceeds 4. This suggests that to maintain the stability of niclosamide in liquid formulations, it is advisable to keep the pH below 4 and to store the drug at lower temperatures. This insight is crucial for pharmaceutical practices, as it indicates the conditions under which niclosamide could safely be stored and handled to minimize degradation.
Alkaline Hydrolysis
The research highlighted the rapid degradation of niclosamide in alkaline conditions, specifically in the presence of sodium hydroxide. The degradation process was studied using spectrophotometry and HPLC, revealing that exposure to 0.1M sodium hydroxide leads to the generation of new degradation products, including a yellow compound with a maximum absorbance at 409 nm. This reinforces the conclusion that niclosamide is highly susceptible to hydrolysis, particularly under alkaline conditions, which can significantly affect its efficacy if not properly managed.
Photostability of Niclosamide
Another crucial aspect of the study was the examination of niclosamide's stability under light exposure. The findings showed that niclosamide is a photosensitive compound that degrades when exposed to both sunlight and ultraviolet (UV) light. The first derivative spectra indicated the formation of photodegradation products over time, emphasizing the need to protect niclosamide formulations from light to maintain their stability and therapeutic effectiveness. Such insights are essential for pharmaceutical companies in terms of packaging and storage to ensure drug integrity.
Conclusion
The comprehensive stability study of niclosamide elucidates its vulnerabilities under varying conditions, particularly how pH, alkali, and light exposure negatively impact its stability. The developed analytical methods have proven effective for monitoring the degradation process, and the study underscores the precautions necessary for handling and storing niclosamide. Overall, this research contributes important data to the field of pharmaceutical chemistry concerning the stability profiles of drugs and informs best practices for their formulation and usage.
FAQ section (important questions/answers):
What methods were used to study the stability of Niclosamide?
The study employed first derivative spectrophotometry, high-performance liquid chromatography (HPLC), and thin-layer chromatography (TLC) to analyze the stability of Niclosamide under various conditions.
How does pH affect the stability of Niclosamide?
Niclosamide is stable at pH values between 1-4, but degradation starts at pH values above 4. Hydrolysis increases as pH rises, indicating higher instability in alkaline conditions.
What temperature conditions were tested for Niclosamide stability?
The effect of temperature on Niclosamide stability was tested at 70°C, 80°C, and 100°C, revealing rapid degradation without significant temperature variation effects.
What impact does light exposure have on Niclosamide?
Niclosamide is photosensitive and degrades upon exposure to light, including both sunlight and UV light, leading to the formation of degradation products.
What were the main degradation products identified for Niclosamide?
The degradation process primarily results in the formation of chlorosalicylic acid, a fluorescent compound, and 2-chloro-4-nitroaniline, indicated by spectral changes.
How was the stability-indicating method for Niclosamide developed?
A stability-indicating thin-layer chromatographic method was developed to separate Niclosamide from its degradation products, confirming the presence of functional groups associated with stability.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “Stability study of niclosamide using spectroscopy and chromatography.”. This list explains important keywords that occur in this article and links it to the glossary for a better understanding of that concept in the context of Ayurveda and other topics.
1) Drug:
The term drug refers to niclosamide, a potent anthelmintic agent studied in this research. Understanding its stability is crucial for effective formulation and application in treating parasitic infections. The drug's susceptibility to degradation under various conditions influences its pharmacological efficacy, safety, and storage requirements in pharmaceutical formulations.
2) Study (Studying):
The study was designed to assess the stability of niclosamide under different pH levels, temperatures, and light conditions. It employed various analytical methods like derivative spectrophotometry, HPLC, and TLC to evaluate the drug's degradation, which informs the development of stable formulations and storage guidelines for the drug in clinical settings.
3) Glass:
Glass refers to the materials used in laboratory instruments, such as glass tubes and bottles for sample preparation and stability testing. Its transparency is essential for optical methods, like spectrophotometry. The use of glass minimizes contamination and chemical reactions, ensuring accurate results during the degradation assessments of niclosamide.
4) Water:
Water is a vital solvent used in the preparation of buffers and dilutions for niclosamide stability testing. It acts as a medium where chemical reactions occur, influencing degradation rates and providing a controlled environment to monitor interactions between niclosamide and other reactive substances during experimentation.
5) Table:
Tables in the research present vital data like the degradation rates of niclosamide under varying conditions and concentrations of sodium hydroxide. They offer concise visibility of results, allowing for easier interpretation of trends, dependencies, and calculations of stability parameters. This format aids in summarizing and communicating key findings.
6) Egypt:
Egypt is relevant as the location where the niclosamide samples and reference standards were sourced. The research highlights the availability and quality of pharmaceutical substances in different regions, which emphasizes the need for localized studies to address the drug stability and formulation issues pertinent to specific environmental conditions.
7) Cutan:
Sudan is significant because it is the institutional backdrop where the research was conducted. The study's findings can help inform pharmacological practices and regulations in Sudan, emphasizing the importance of regional studies in understanding drug stability, especially in areas with specific climatic and storage conditions crucial for pharmaceutical development.
8) Life:
Life pertains to the broader context of the research, which aims to enhance the efficacy and safety of treatments for parasitic infections affecting human health. Understanding the stability of niclosamide contributes to better clinical outcomes, ensuring that drug formulations remain effective and safe for patients throughout their shelf life.
9) Performance:
Performance refers to the effectiveness of analytical methods employed in this study, such as HPLC and derivative spectrophotometry, in determining the stability of niclosamide. The accuracy and reliability of these methods directly impact the results obtained, which are critical for forming conclusions on the drug's degradation pathways and stability over time.
10) Discussion:
Discussion encompasses the interpretation of the results obtained in the research. It addresses the implications of niclosamide's stability, the relevance of degradation products, and their potential effects on therapeutic efficacy. This section is vital for framing the study's findings within the larger context of pharmaceutical development and drug safety.
11) Developing:
Developing relates to the processes undertaken to create new analytical methods for assessing the stability of niclosamide. This includes establishing the first derivative spectrophotometry and HPLC techniques, which enhance the understanding of the drug's behaviour under different environmental conditions, contributing to the formulation of more effective pharmaceutical products.
12) Knowledge:
Knowledge is central to the research's objective, as it seeks to advance the understanding of niclosamide's chemical stability under various conditions. This acquired knowledge is crucial for informing better pharmaceutical practices and regulatory frameworks, ultimately aiming to improve drug formulations, efficacy, and patient safety.
13) Heating:
Heating is a critical variable in the study as it investigates the effects of elevated temperatures on niclosamide stability. The research explores how heating accelerates degradation processes and provides insights into the thermal stability of the drug, essential for formulating effective storage guidelines to maintain its effectiveness.
14) India:
India is relevant in the context of sourcing chemicals for the study, specifically acetonitrile, which is used as a solvent in the analytical methods. Moreover, it points to the global nature of pharmaceutical research, emphasizing that various regions contribute to the raw materials used in drug testing and development.
15) Field:
Field refers to the specific area of research within pharmaceutical sciences focused on drug stability. The complexities of drug behavior in various conditions make the field essential for ensuring effective treatments. This research contributes to the ongoing dialogue and understanding in this vital area of pharmaceutical development.
16) Worm:
Worm pertains to the type of parasites that niclosamide is used to combat, underscoring the drug's therapeutic application. Understanding the drug's stability leads to better treatment options for infections caused by helminths, which is essential for improving health outcomes and addressing global public health challenges.
Other Science Concepts:
Discover the significance of concepts within the article: ‘Stability study of niclosamide using spectroscopy and chromatography.’. Further sources in the context of Science might help you critically compare this page with similair documents:
Water-bath, High performance liquid chromatography, Thin Layer Chromatography, Molecular weight, Retention time, Mobile phase, Solvent system, Chromatographic separation, Chemical stability, Photosensitivity, Stability Studies, Spectrophotometric method, Storage condition, Degradation process.