Developing and validating a UV spectrophotometric method for fluconazole.
Journal name: World Journal of Pharmaceutical Research
Original article title: U.v. spectrophotometric method development and validation for estimation of fluconazole
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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Original source:
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Yadav Anandkumar, Sonali Kapse-Mistry, Pramod Kadu
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: U.v. spectrophotometric method development and validation for estimation of fluconazole
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
Copyright (license): WJPR: All rights reserved
Summary of article contents:
Introduction
Fluconazole, an antifungal agent in the triazole class, has been widely studied for its efficacy in treating various fungal infections. Approved by the FDA in 1990, it exhibits high solubility in methanol and limited solubility in water. The drug works by inhibiting the fungal enzyme 14α-demethylase, which is essential for converting lanosterol to ergosterol, a crucial constituent of the fungal cell membrane. Despite its effectiveness, resistance to Fluconazole can occur, particularly among immunocompromised patients, due to mutations in the ERG11 gene.
Resistance Mechanisms
Fungal resistance to azole antifungals, including Fluconazole, primarily develops through genetic mutations and enhanced drug efflux mechanisms. Specifically, in Candida albicans, mutations in the ERG11 gene hinder Fluconazole's binding capability, while still allowing lanosterol to bind effectively. The development of resistance can compromise treatment efficacy in patients with conditions like advanced HIV. Additionally, both C. albicans and C. glabrata can increase the rate at which Fluconazole is expelled from their cells, contributing to overall resistance against this class of antifungal drugs.
Method Development and Validation
The research presented aimed to develop a reliable and efficient U.V. spectrophotometric method for estimating Fluconazole concentrations. The method was validated according to the International Council for Harmonisation (ICH) guidelines, testing parameters such as linearity, precision, accuracy, robustness, limit of detection (LOD), and limit of quantification (LOQ). The developed method demonstrated high linearity across a concentration range of 25 to 500 µg/ml, along with a remarkable correlation coefficient of 0.999. The LOD and LOQ were calculated as 1.59 µg/ml and 4.82 µg/ml, respectively.
Results on Precision and Accuracy
The precision of the developed method showed a % relative standard deviation (% RSD) of less than 2% for both intraday and interday measurements, indicating consistent accuracy across different testing days. Accuracy was affirmed through recovery studies, achieving percentages ranging from 98% to 99%, further validating the method's reliability. Furthermore, robustness testing indicated that minor variations in the measurement wavelength yielded recoveries between 98% and 100%, reinforcing the method’s reliability for routine analysis.
Conclusion
The U.V. spectrophotometric method developed for estimating Fluconazole concentrations is characterized by its simplicity, rapidity, precision, and cost-effectiveness. This method stands as a valuable tool for routine quality control of pharmaceutical formulations containing Fluconazole, particularly useful in light of the challenges posed by antifungal resistance. Continuous monitoring of this resistance and development of robust analytical methods are crucial for ensuring effective treatment outcomes in patients facing fungal infections.
FAQ section (important questions/answers):
What is the primary use of Fluconazole?
Fluconazole is a synthetic antifungal agent used to treat local and systemic fungal infections, particularly candidiasis, by inhibiting the conversion of lanosterol to ergosterol in fungal cells.
What was the method developed for Fluconazole estimation?
A rapid, simple, and precise U.V. spectrophotometric method was developed for estimating Fluconazole content, with detection at a wavelength of 260.8nm in water.
What were the limits of detection and quantification for the method?
The limit of detection (LOD) for Fluconazole was found to be 1.59μg/ml, while the limit of quantification (LOQ) was 4.82μg/ml.
How was the method validated according to ICH guidelines?
The method was validated in accordance with ICH guidelines, assessing linearity, precision, accuracy, robustness, and limits of detection and quantification.
What concentration range showed linearity in the method?
Linearity was observed in the concentration range of 25μg/ml to 500μg/ml with a high correlation coefficient of 0.999.
What significant adverse effects are associated with Fluconazole therapy?
Adverse drug reactions may include rash, nausea, vomiting, headache, dizziness, and increased liver enzymes during Fluconazole therapy.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “Developing and validating a UV spectrophotometric method for fluconazole.”. 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 substances used to diagnose, cure, treat, or prevent diseases. In this context, Fluconazole represents a drug essential for treating fungal infections. Understanding its properties and methods for analysis is crucial for ensuring efficacy and safety in pharmaceutical formulations and patient care.
2) Water:
Water serves as a solvent in the spectrophotometric method for Fluconazole analysis. Its role is critical as it allows the solubilization and homogeneity of the drug solution, facilitating accurate measurements of absorption at specific wavelengths. The choice of solvent affects analysis validity and reproducibility.
3) Table:
In pharmaceutical research, a 'Table' refers to structured data presentation summarizing findings, such as drug concentrations, mean absorbance, standard deviation, and % recovery results. Tables make it easier to visualize and interpret complex data, allowing researchers and clinicians to assess the validity of the analytical methods used.
4) Performance:
'Performance' relates to how well the developed method functions in terms of precision, accuracy, and reliability. In this study, the performance metrics guarantee the method's effectiveness in quantifying Fluconazole concentrations, highlighting its suitability for routine analysis in quality control of pharmaceutical preparations.
5) Mutation:
The term 'Mutation' refers to changes in the genetic material, which can lead to drug resistance in pathogens like Candida species. Fluconazole resistance is often attributed to mutations in genes encoding for critical enzymes, affecting treatment effectiveness. Understanding mutations guides healthcare professionals in optimizing antifungal therapies.
6) Indian:
The term 'Indian' references the geographical and cultural context of the research presented in this study. The research conducted in India emphasizes the local pharmaceutical industry's contribution to antifungal drug development and validation, showcasing regional innovations that cater to both domestic needs and global standards.
7) India:
India is significant in the global pharmaceutical landscape, known for its robust drug manufacturing and research capabilities. The mention of India highlights the origin of the research, involving local institutions and resources that contribute to advancements in drug analysis, particularly for Fluconazole, a valuable antifungal drug.
8) Kumar:
Kumar is a common surname in India, likely referring to one of the authors of the study, Yadav Anandkumar. Such names in publications establish authorship and accountability for the research, ensuring proper recognition of contributors involved in the development and validation of analytical techniques.
9) Pharmacological:
The term 'Pharmacological' pertains to the study of drug actions and their therapeutic effects. Understanding the pharmacological properties of Fluconazole guides researchers in evaluating its efficacy, safety, and potential side effects. This knowledge is essential for developing effective treatment protocols and minimizing adverse reactions.
10) Accumulation (Accumulating, Accumulate):
'Accumulation' in this context refers to the build-up of certain substances, such as 14α-methyl sterols, in fungal cells due to Fluconazole's action. This concept is relevant in understanding how Fluconazole disrupts fungal cell membranes, highlighting its mode of action and the resulting therapeutic impact in infections.
11) Measurement:
Measurement refers to the process of obtaining quantitative data on drug concentrations. In this study, various measurement techniques, including UV-spectrophotometry, are used to ensure accurate and reliable quantification of Fluconazole. Proper measurement is critical for validating its presence in pharmaceutical formulations.
12) Discussion:
The term 'Discussion' signifies a section in research papers where results are interpreted and implications are analyzed. It allows authors to connect findings to hypotheses, highlight significance, and suggest applications. This critical section guides future research directions and enhances understanding of the study's contributions.
13) Science (Scientific):
'Scientific' refers to the systematic study of natural phenomena, characterized by the application of the scientific method. This research embodies scientific principles in its methodology, ensuring rigorous validation of the UV-spectrophotometric method for Fluconazole, contributing to the body of knowledge in pharmaceutical science.
14) Vomiting:
Vomiting, a possible adverse drug reaction associated with Fluconazole, is crucial for clinicians to understand. Recognizing the side effects of medications affects treatment strategies and patient compliance. Awareness of such reactions guides healthcare professionals in monitoring and managing patients receiving Fluconazole therapy.
15) Activity:
Activity refers to the biological effects or pharmacological actions of Fluconazole as an antifungal agent. Understanding its activity is essential for assessing its efficacy against fungal infections and optimizing its therapeutic use. Knowledge about its mechanism of action informs both clinical practice and research on antifungal treatments.
16) Lakshmi (Laksmi):
Lakshmi is another name referenced in the context of Indian pharmaceutical research. It may refer to an author or contributor who is part of the study's team, emphasizing teamwork in conducting validated research methods like the analysis of Fluconazole, ultimately contributing to pharmaceutical advancements.
17) Channel:
'Channel' could refer to cellular transport channels responsible for drug absorption or efflux mechanisms in pharmacology. In the context of this paper, understanding how these channels operate is integral to elucidating the interactions between Fluconazole and fungal cells, which is pertinent for addressing drug resistance.
18) Thomas:
Thomas may reference an author, participant, or contributor related to pharmacological research. Such references establish a network of research and collaboration within the scientific community, highlighting multidisciplinary efforts aimed at enhancing the understanding of drugs like Fluconazole and their therapeutic applications.
19) Balaji:
Balaji is likely a contributor to the research, showcasing the collaborative nature of scientific studies. Acknowledging contributors is vital for intellectual property rights and fosters an environment of teamwork, promoting better outcomes in research such as Fluconazole analysis within the pharmaceutical context.
20) Nausea:
Nausea is a common adverse effect associated with Fluconazole therapy. Recognizing and managing nausea is essential in clinical practice because it can affect patient compliance with antifungal treatments. Understanding potential side effects allows healthcare providers to offer supportive care and improve patient outcomes.
21) Sharman (Sarma, Sharma, Sarman):
Sharma is another common surname among researchers, possibly indicating co-authorship in the study. Recognizing all contributors fosters accountability and credits the collaborative efforts of individuals involved in the research, specifically in innovative methods developed for the analysis of important medications like Fluconazole.
22) Powder:
Powder refers to the physical state of Fluconazole, which is a crystalline powder used in pharmaceutical formulations. The powder form impacts solubility, stability, and administration routes. Knowledge of the chemical and physical properties of drug powders is essential for formulation scientists in creating effective medications.
23) Matti:
Mathi may refer to a contributor or researcher involved in the study of Fluconazole. Acknowledgment of all contributing names signifies the collaborative approach in pharmaceutical research, highlighting the importance of teamwork and diverse expertise in developing and validating methodologies for drug analysis.
24) Kadu:
Kadu appears to be another contributing author, further emphasizing the collaborative nature of pharmaceutical research. Each author's involvement signifies a collective effort in advancing scientific knowledge, particularly regarding the development and validation of methods for analyzing significant drugs such as Fluconazole.
25) Ras (Rash):
Rash is a potential adverse effect experienced by some patients during Fluconazole therapy. Understanding this reaction is vital for healthcare providers, as it impacts patient safety and treatment adherence. Knowledge of adverse effects like rashes facilitates monitoring and management, promoting better therapeutic outcomes.
26) Pain:
'Pain' can refer to potential side effects experienced by patients taking Fluconazole, impacting their quality of life. Recognizing and managing pain associated with medication is essential in clinical care, guiding healthcare providers to explore alternatives or adjunctive therapies to enhance patients' comfort and adherence.
27) Milk:
Milk is relevant because Fluconazole is secreted in human milk at concentrations similar to those in plasma. This connection raises considerations for lactating mothers, emphasizing the importance of evaluating drug safety during breastfeeding to protect both maternal and infant health when considering treatment options.
28) Chan:
Chan might refer to a contributor to the research or a notable figure in pharmaceutical studies. Recognizing individuals' contributions is essential for scholarly communication and integrity. It reflects collaborative efforts in research that advance the understanding and validation of analytical methods in pharmacology.
Other Science Concepts:
Discover the significance of concepts within the article: ‘Developing and validating a UV spectrophotometric method for fluconazole.’. Further sources in the context of Science might help you critically compare this page with similair documents:
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