Method development and validation for ivermectin quantification.

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Journal name: World Journal of Pharmaceutical Research
Original article title: Development and validation of an analytical method for quantification of ivermectin analysis
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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Author:

Shiba S. Morris, Md. Daneyal Khurshid and Anisha Arya


World Journal of Pharmaceutical Research:

(An ISO 9001:2015 Certified International Journal)

Full text available for: Development and validation of an analytical method for quantification of ivermectin analysis

Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research

Doi: 10.20959/wjpr202313-29063


Download the PDF file of the original publication


Summary of article contents:

Introduction

Ivermectin is a therapeutic drug extensively used for treating and preventing various parasitic infections affecting both humans and animals. Its significance in veterinary medicine and potential applications in human health underscore the need for rigorous analytical methods to ensure the drug’s quality, safety, and efficacy. This research paper discusses the development and validation of an analytical method specifically for quantifying Ivermectin, focusing on the implementation of a reverse-phase high-performance liquid chromatography (RP-HPLC) technique. The study aims to provide reliable means of determining Ivermectin's concentration in pharmaceutical formulations.

Development of RP-HPLC Method

The research developed a robust RP-HPLC method for analyzing Ivermectin in tablet dosage forms. Using a Waters model 2489 chromatographic system, the separation process utilized an INERTSIL C-18 ODS column and employed acetonitrile and methanol as the mobile phase, flowing at 1 ml/min while detecting at a wavelength of 245 nm. The method demonstrated excellent linearity within a concentration range of 1-32 µg/ml, with a correlation coefficient of 0.9798. The retention time for Ivermectin was established to be 4.198 minutes, indicating a reliable detection for routine analysis in various formulations.

Method Validation Parameters

Validation of the developed RP-HPLC method was performed following established guidelines from the International Council for Harmonisation (ICH). Parameters such as precision, accuracy, specificity, and robustness were meticulously evaluated. The intraday and interday precision of the results were within acceptable limits, exhibiting percent relative standard deviations (RSD) of 1.6283 and 1.352, respectively. The limits of quantification (LOQ) and detection (LOD) were determined to be 8.79 and 2.93, respectively, confirming the method’s sensitivity and reliability. These validation studies demonstrate that the method is well-suited for routine quality control of Ivermectin.

Importance of Accurate Analytical Methods

Accurate analytical methods are crucial for ensuring the quality of Ivermectin formulations, which can directly impact therapeutic outcomes. The study highlights the significance of method development in assessing parameters such as sample preparation techniques, instrument performance, and potential interferences that may affect analytical precision. The comprehensive evaluation of quality control measures emphasizes the role of validated methodologies in safeguarding public health by ensuring that pharmaceutical products meet established safety and efficacy standards.

Conclusion

The successful development and validation of a new RP-HPLC analytical method for Ivermectin substantiate its practicality for routine pharmaceutical analysis. By employing a straightforward and precise approach, the study affirms that this methodology can effectively quantify Ivermectin concentrations in various formulations, aiding quality control efforts. The findings underscore the importance of methodological reliability in pharmaceutical practices, ensuring the safe and effective use of Ivermectin in treating parasitic infections. The research contributes valuable insights to the field of pharmaceutical analysis, paving the way for enhanced monitoring of drug quality.

FAQ section (important questions/answers):

What is the purpose of this research paper?

The research paper aims to develop and validate an accurate analytical method for quantifying Ivermectin, a drug used for treating parasitic infections in humans and animals, ensuring its quality and efficacy in pharmaceutical applications.

What analytical technique was developed for Ivermectin analysis?

A reverse-phase high-performance liquid chromatography (RP-HPLC) technique was developed. This method is characterized by its accuracy, simplicity, selectivity, and rapid execution for determining Ivermectin in various pharmaceutical formulations.

What were the key validation parameters for the RP-HPLC method?

The key validation parameters included linearity, precision, accuracy, robustness, limit of detection (LOD), and limit of quantification (LOQ). The method demonstrated suitability according to ICH standards.

What results were found regarding the solubility of Ivermectin?

Ivermectin's solubility was tested in several solvents, and acetonitrile and methanol were selected as the solvent system for the HPLC method, based on effective solubilization.

What were the detected values for LOD and LOQ?

The Limit of Detection (LOD) for Ivermectin was determined to be 2.93 µg/ml and the Limit of Quantification (LOQ) was found to be 8.79 µg/ml, indicating the method's sensitivity.

How does the developed method ensure its reliability for routine analysis?

The developed RP-HPLC method ensures reliability by demonstrating linearity, precision, accuracy, and robustness, along with successful recovery studies that confirm its effectiveness in routine quality control assessments.

Glossary definitions and references:

Scientific and Ayurvedic Glossary list for “Method development and validation for ivermectin quantification.”. 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:
'Drugs' encompass a wide range of chemical substances used for medical purposes, including treatment and prevention of diseases. The analysis of Ivermectin and similar pharmaceuticals falls within this broader context, highlighting the importance of ensuring quality control for all types of drugs.

2) Table:
A 'table' in research presents organized numerical or categorical data, facilitating clarity and comparison. In this research, various tables illustrated the solubility tests, calibration curves, and analytical parameters of Ivermectin, providing essential quantitative data for evaluating the method's effectiveness. Tables enable efficient data analysis in scientific studies.

3) Quality:
'The quality' pertains to the attributes or characteristics that define how effective and safe a drug is. The phrase emphasizes the importance of assessing and ensuring the quality of Ivermectin through validated analytical methods, which is vital for maintaining therapeutic effectiveness and minimizing risks for users.

4) Water:
'Waters' refers to the specific brand of HPLC equipment (model 2489) used in the study. It underscores the relevance of using quality and reliable instruments in the development and validation of analytical methods, which is crucial for achieving accurate and reproducible results.

5) Study (Studying):
'The study' emphasizes the specific research undertaken in the paper, involving the development and validation of an analytical method for Ivermectin. This phrase underscores the systematic approach taken to explore relevant scientific questions and gather meaningful data in drug analysis.

6) Performance:
'Performance' relates to how well a method or process works under specified conditions. In analytical chemistry, performance metrics include sensitivity, precision, and accuracy. Assessing performance in the context of method validation ensures that the developed method consistently meets established criteria for drug analysis.

7) Patel:
'Patel' refers to an author or researcher who has contributed to the field of pharmaceutical analysis. The work of various researchers, including Patel, is often compared to assess advancements or establish benchmarks in analytical methods for drugs like Ivermectin, thereby enriching the academic discourse in the field.

8) Substance:
'Substance' is a term used interchangeably with 'substances' to denote any material with definitive chemical composition. In the context of analytical methods development, understanding the properties of the specific substance (Ivermectin) is crucial for optimizing analytical conditions and ensuring effective quantification and validation.

9) Observing:
'Observing' refers to the act of monitoring and recording information or characteristics. In analytical research, observing changes in sample behavior, such as solubility or retention times, is essential for validating methods and ensuring that quantitative measurements are reliable and reproducible throughout the study.

10) Animal:
'Animal' refers specifically to non-human organisms used in the context of veterinarian care. Ivermectin is utilized to treat various animal diseases caused by parasites, underlining the importance of effective analytical methods that ensure the drug's purity and potency essential for animal health.

11) Bhavya:
'Bhavya' is a reference to an author of a previous study related to Ivermectin analysis. As cited in the paper, comparison with Bhavya's results regarding retention times and method validations provides a context for evaluating the effectiveness of the new studied method in relation to established benchmarks.

12) Purity:
'Purity' denotes the freedom from contaminants or adulterants in a substance. For Ivermectin, assessing purity through validated analytical methods ensures that the pharmaceutical product meets safety and effectiveness standards, which is critical in both human and veterinary medicine applications.

13) Veterinary medicine:
'Veterinary medicine' is the branch of medicine that deals with the prevention, diagnosis, and treatment of diseases in animals. Ivermectin's usage in veterinary practices necessitates reliable analytical methods to ensure the quality and safety of medications administered to animals.

14) Nature:
'Nature' signifies the innate characteristics of a substance such as Ivermectin. Understanding the nature of a drug is essential for formulating effective analytical methods to achieve reliable results during the assessment of its efficacy and safety, impacting both human and animal health.

15) Field:
'Field' often refers to a particular area of expertise or study. In the context of this research, the field encompasses pharmaceutical sciences, particularly analytical chemistry, and serves as the backdrop against which the specific study on Ivermectin is conducted.

16) Measurement:
'Measurement' refers to the process of determining a quantity or degree. In analytical chemistry, accurate measurement is crucial for obtaining reliable data about drug concentrations and purity. The effectiveness of analytical methods relies on precise measurements to ensure the safety and efficacy of pharmaceuticals.

17) Reliability:
'Reliability' indicates the consistency and dependability of a method or result. In analytical methodologies, establishing reliability ensures that the methods can consistently produce accurate results, which is crucial for regulatory compliance and maintaining high standards in pharmaceutical analysis.

18) Discussion:
'Discussion' refers to the section of a research paper where results are interpreted and contextualized. In this study, the discussion analyzes findings related to the developed analytical method for Ivermectin and compares them to existing literature, fostering a deeper understanding of the results’ implications.

19) Medicine:
'Medicine' refers not only to drugs used to treat illness but also the broader field of healthcare practices. This paper highlights Ivermectin’s relevance within medicine, focusing on its applications for treating parasitic infections in both humans and animals, emphasizing quality analytical practices.

20) Activity:
'Activity' refers to the effectiveness or action of a drug against a targeted disease or condition. The paper discusses Ivermectin's broad-spectrum activity against various parasitic infections, thereby underscoring the importance of reliable analytical methods in confirming and validating its therapeutic benefits.

21) Relative:
'Relative' denotes a comparison between two or more entities. In this study, relative analyses are used to evaluate the developed analytical method against previously established methods in terms of precision, accuracy, and other validation parameters, enabling researchers to gauge improvements or differences.

22) Devaka:
'Devaka' refers to another researcher in the field. By comparing findings with Devaka's work, the study outlines the effectiveness of the RP-HPLC method for quantifying Ivermectin, which allows the research community to reflect on advancements made in analytical methodologies for pharmaceuticals.

23) Indore:
'Indore' refers to the location where Ivermectin samples were sourced from Sell Well Pharmaceuticals. The geographical aspect emphasizes the importance of regional pharmaceutical companies in supplying raw materials for research and the overall pharmaceutical landscape, impacting drug analysis and development activities.

24) Filling (Filled):
'Filled' in this context relates to the process of preparing samples for analysis. It involves filling a capillary tube with the substance for melting point determination—an essential part of establishing the characteristics of Ivermectin for method development and validation.

25) Naga (Nag):
'Naga' refers to a researcher whose findings may be discussed or compared within this context. Mentioning Naga's work helps to establish a foundation for evaluating the developed analytical method against previously published research, contributing to scientific dialogue and collaboration in the field.

26) Arya:
'Arya' designates one of the contributors to this research study, contributing to the collaborative effort of method development. The acknowledgment of multiple authors reflects the collective expertise and input that fosters innovation and improvements in analytical methodologies in pharmaceutical sciences.

27) Line:
'Line' often pertains to the graphical representation of a correlation in a calibration curve. In analytical studies, a linear relationship between concentration and response indicates the reliability of the method, making it essential for quantifying substances accurately in various formulations.

Other Science Concepts:

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Discover the significance of concepts within the article: ‘Method development and validation for ivermectin quantification.’. Further sources in the context of Science might help you critically compare this page with similair documents:

Analytical method, Statistical analysis, Quality Control, Quality control measures, Solubility Test, Chromatogram, Retention time, Pharmaceutical analysis, Melting point, Limit of detection, Limit of quantification, Method development, Sample preparation, Therapeutic Effectiveness, Calibration curve, Intraday precision, Interday precision, Instrumental analysis, Method validation, Regulatory compliance, Chromatographic condition.

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