UV-spectrophotometric method for moxidectin validation in mixtures
Journal name: World Journal of Pharmaceutical Research
Original article title: Method development and validation of moxidectin in synthetic mixture using uv-spectrophotometry
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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P Sathish Babu, K. Anand Babu, D Revathi and K Chitra
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: Method development and validation of moxidectin in synthetic mixture using uv-spectrophotometry
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
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Summary of article contents:
Introduction
Moxidectin is a semi-synthetic derivative of the compound LL F-2924α, known for its broad-spectrum efficacy against various parasites including insects and nematodes. This article discusses the development and validation of a sensitive UV spectrophotometry method for quantifying Moxidectin in both bulk drug and synthetic mixtures. Notably, this technique has been validated according to guidelines set by the International Conference on Harmonization (ICH), ensuring reliability in various analytical conditions.
Method Development and Validation
The study successfully developed a UV spectrophotometric method capable of detecting Moxidectin concentrations ranging from 8 to 22 µg/ml, with an impressive correlation coefficient of 0.9994. The method underwent rigorous validation processes, revealing a Limit of Detection (LOD) of 0.0264 µg/ml and a Limit of Quantification (LOQ) of 0.08 µg/ml. Variations were minimized, achieving a percentage Relative Standard Deviation (RSD) for precision of less than 2%, demonstrating the method’s reliability.
Linearity and Accuracy
An important aspect of the validation was establishing the linearity of the method. This was assessed through calibration curves plotting absorbance against concentration, showing a robust linear relationship in the tested concentration range. In addition to linearity, the accuracy of the method was confirmed through recovery studies at different concentration levels (80%, 100%, and 120%), with average recoveries of 100.25%, 100.62%, and 100.81%, respectively, indicating that the method is both reliable and precise across various sample concentrations.
Specificity and Precision
This method's specificity was verified through tests showing that the other components in the synthetic mixture did not interfere with Moxidectin measurement. Precision was measured through repeated assays, with the results indicating a very low RSD of 0.0397%, underscoring the reproducibility of the method. Such precision is critical in pharmaceutical analysis for maintaining quality control, making this method highly suitable for routine analysis in laboratories.
Conclusion
In conclusion, the developed UV spectrophotometry method for determining Moxidectin is confirmed to be simple, accurate, precise, and cost-effective. With a validation process that adheres to ICH guidelines, this method provides a dependable analytical tool for assessing Moxidectin in various formulations. It presents itself as an advantageous option for routine analysis, offering high recovery rates and excellent precision, thus supporting its application in quality control within pharmaceutical settings.
FAQ section (important questions/answers):
What is the purpose of the developed UV Spectrophotometry method?
The method was developed to determine Moxidectin in both bulk drug and synthetic mixtures accurately and sensitively. It follows ICH guidelines for validation, ensuring reliability in pharmaceutical analysis.
What is Moxidectin and its primary use?
Moxidectin is a potent endectocide used worldwide as a parasiticide in various mammalian species. It effectively combats a wide range of parasites, including insects, nematodes, and acari.
How was the accuracy of the UV method assessed?
Accuracy was evaluated using the standard addition method, involving spiking synthetic mixtures with different concentrations of Moxidectin. The average recovery percentages were found to be around 100%.
What were the limits of detection and quantification for Moxidectin?
The Limit of Detection (LOD) for Moxidectin was 0.0264 µg/ml, while the Limit of Quantification (LOQ) was 0.08 µg/ml, making the method highly sensitive for analysis.
What results were obtained regarding the precision of the method?
The precision of the method, measured as % Relative Standard Deviation (RSD), was found to be less than 2%, specifically 0.0397%, indicating high repeatability and consistency.
What are the key validation parameters of the method?
Key validation parameters included linearity (correlation coefficient of 0.9994), accuracy (with recovery around 100%), specificity, LOD, LOQ, and precision (%RSD less than 2%), confirming method reliability.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “UV-spectrophotometric method for moxidectin validation in mixtures”. 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 a substance used in the diagnosis, cure, mitigation, treatment, or prevention of diseases. In the context of the study, Moxidectin is highlighted as a potent endectocide, used widely in veterinary medicine to address parasitic infections across a variety of mammalian species.
2) Table:
In scientific literature, a 'Table' serves a vital role in organizing data succinctly. Tables in the document present essential experimental data, such as calibration results and recovery studies, allowing readers to quickly access and assess critical findings relevant to Moxidectin’s quantitative analysis.
3) Water:
'Water', particularly in the context of chromatography and analytical chemistry, often refers to a solvent used in preparations and dilutions. High-purity water is crucial for ensuring that no contaminants interfere with the results of the UV spectrophotometry method developed for analyzing Moxidectin.
4) Study (Studying):
'Study' indicates a systematic investigation into a particular subject, in this case, the development and validation of a UV spectrophotometric method for Moxidectin analysis. The study comprises comprehensive methodologies, results, and conclusions that contribute to the analytical chemistry field and veterinary pharmacology.
5) Babu:
'Babu' is part of the author's name, specifically K. Anand Babu. Names in academic texts attribute the work to the researchers, providing credibility and acknowledgment. K. Anand Babu is a co-author contributing to the validation methods and analyses presented in the paper.
6) Calculation:
'Calculation' refers to the mathematical determination of values derived from experimental data. The paper includes various calculations, such as determining the limits of detection and quantification, which are essential for showcasing the accuracy and reliability of the proposed UV-spectrophotometric method.
7) Tamilnadu (Tamil-nadu):
'Tamil Nadu' is a state in southern India, providing geographic context for the research conducted at Sri Ramachandra University. Mentioning this region highlights the local importance of the study, which can have implications for agriculture, veterinary practices, and public health within that area.
8) Activity:
'Activity' refers to the biological efficacy of Moxidectin as a drug. The study emphasizes the drug's broad-spectrum activity against various parasites, which is crucial for its role in treating infections in target species, underlying its significance in veterinary therapeutics.
9) Relative:
'Relative' denotes comparison or proportion in scientific contexts. In the study, it pertains to calculations of relative standard deviation (%RSD), which is an expression of precision. This metric helps ascertain the reliability and reproducibility of the analytical method employed in the study.
10) Chennai:
'Chennai' is the capital city of Tamil Nadu and the location where the research was conducted. Its mention not only identifies the institutional affiliation but also contextualizes the study geographically, indicating where significant pharmaceutical research and education occur within India.
11) India:
'India' denotes the country of origin for the research. Highlighting India provides a larger context for the significance of Moxidectin in its regional veterinary practices, and fosters awareness about the broader implications of pharmaceutical developments in developing nations' healthcare.
12) Tamil:
'Tamil' refers to the ethnic group and language native to Tamil Nadu, Sri Lanka, and other regions. Acknowledging Tamil heritage may align with cultural considerations, particularly in how local practices in agriculture and veterinary use might influence the application of drugs like Moxidectin.
13) Nadu:
'Nadu' completes the name of the state ‘Tamil Nadu’. Understanding it as part of the full title identifies cultural and regional context, supporting the significance of local research activities, including the study's potential impact on local veterinary care and education in pharmacy.
14) Purification:
'Purification' in this context refers to the process of obtaining high-quality water free from contaminants for experimental use. It is crucial in analytical chemistry, ensuring that the solvent used in the preparation and analysis does not interfere with the results of Moxidectin determination.
15) Discussion:
'Discussion' is a section in scientific literature where authors interpret results and relate them to other research. In this study, the discussion evaluates the implications of the findings on Moxidectin's use and explores potential applications of the validated UV method in quality control.
16) Vinayaka:
'Vinayaka' refers to Vinayaka Mission College of Pharmacy, which provided support for the study. Mentioning this institution underscores the collaborative efforts in research and highlights the importance of academic partnerships in furthering pharmaceutical sciences and drug development.
17) Channel:
'Channel' refers to the ligand-gated chloride channels that Moxidectin targets in parasites, explaining its mode of action. By binding to these channels, Moxidectin increases chloride ion permeability, leading to paralysis and death of the target organism, which is essential in understanding its effectiveness.
18) Quality:
'Quality' in the context of pharmaceuticals refers to the safety, efficacy, and reliability of a drug. The developed method aims to ensure high-quality analysis of Moxidectin, incorporating parameters that adhere to rigid standards, crucial for regulatory compliance and consumer trust in veterinary medicines.
19) Species:
'Species' refers to different kinds of organisms that Moxidectin is effective against. The study emphasizes its broad-spectrum application, illustrating the compound’s relevance across multiple mammalian species, thereby highlighting its utility in veterinary medicine for treating parasitic infections.
20) Medium:
'Medium' in the scientific context often denotes the environment in which reactions or analyses occur. For the present study, it refers to the diluents or solvents used in preparing Moxidectin solutions, essential for accurate spectrophotometric analysis.
21) Insect:
'Insect' refers to the numerous pest species that Moxidectin is designed to target. The study outlines the compound’s role in not just treating parasitic infections but also controlling insect populations, highlighting its broader significance in agricultural and veterinary pest management.
22) Powder:
'Powder' refers to the physical state of Moxidectin and the excipients mixed with it in the synthetic formulation. The characterization and measurement of powders are crucial for ensuring accurate dosing and efficacy in subsequent formulations and analyses within pharmaceutical applications.
23) Shalem (Salem):
'Salem' refers to a city in Tamil Nadu, significant in this context as the location of Vinayaka Mission College of Pharmacy. This geographical reference contributes to the academic and research context of the study, emphasizing local contributions to pharmaceutical sciences.
24) Glass:
'Glass' is often referenced as a material used in laboratory equipment, such as volumetric flasks and filter papers. Mentioning glass indicates standard practices in laboratory settings, where glassware is essential for preparing solutions and conducting precise chemical analyses.
25) Death:
'Death' refers to the ultimate effect of Moxidectin on parasites when it binds to chloride channels, causing paralysis. The term underscores the drug's potent efficacy, which is critical for its use in veterinary medicine to control infections in treated species.
26) Noise:
'Noise' in the context of analytical chemistry refers to background signals that can interfere with the detection of a substance. The method developed seeks to minimize these noise factors to ensure high sensitivity in measuring Moxidectin concentrations during spectrophotometric analysis.
27) Line:
'Line' refers to a linear relation established in a calibration curve, indicating the proportionality between concentration and absorbance in UV spectrophotometry. Establishing such a line is crucial for quantifying the analyte accurately, emphasizing the method’s reliability in Moxidectin analysis.
Other Science Concepts:
Discover the significance of concepts within the article: ‘UV-spectrophotometric method for moxidectin validation in mixtures’. Further sources in the context of Science might help you critically compare this page with similair documents:
Basis of comparison, Accuracy, Quality control laboratories, Correlation coefficient, Recovery study, Limit of detection, Limit of quantification, Method development, Calibration curve, Limit of Detection (LOD), Limit of Quantification (LOQ), Analytical method validation, Specificity, Molecular formula, Percentage recovery, Method validation, Standard Stock Solution, Precision, UV-Spectrophotometry, Calibration graph, SYNTHETIC MIXTURE, UV spectrophotometry method, Absorbance, Sonication, Moxidectin, Wavelength Range, Optimization, ICH Guideline, Chromatographic method, Flaccid paralysis, Percentage RSD, Validation parameter, Assay percentage recovery, Specificity Specific LOD, Moxidectin estimation.