Validation of artemether-lumefantrine in pharmaceutical forms.
Journal name: World Journal of Pharmaceutical Research
Original article title: Development and validation of artemether & lumefantrine in pharmaceutical dosage forms
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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Summary of article contents:
Introduction
Artemether and Lumefantrine are dual-combination antimalarial drugs that target malaria infections effectively. This research, conducted by Rajesh et al., focuses on developing and validating a rapid, sensitive, and selective analytical method for the simultaneous estimation of these drugs in pharmaceutical dosage forms using Reverse Phase High-Performance Liquid Chromatography (RP-HPLC). The validation process adhered to ICH guidelines, demonstrating the method’s reliability in meeting specific analytical criteria.
Method Development and Validation
One of the significant advancements introduced in this study is the optimized RP-HPLC method for the assay of Artemether and Lumefantrine. The system utilized a Symmetry C18 column with a mobile phase consisting of a buffer-acetonitrile mixture (40:60 v/v). Important parameters during the method’s validation included system suitability, precision, accuracy, linearity, and robustness. The results indicated that the method had a rapid analysis time of 20 minutes, demonstrating excellent resolution and peak shapes for both compounds, which is crucial for the reliability of analytical results.
Precision and Accuracy
Precision and accuracy are vital components in the validation of any analytical method. In this study, system precision was assessed by injecting standard solutions multiple times, while method precision was evaluated through six sample preparations. The results showed that the Relative Standard Deviation (RSD) for the peak areas of the compounds was well within acceptable limits (not exceeding 2.0%), and the assay percent remained in the specified range of 95.0% to 105.0% for both drugs. This level of precision and accuracy ensures that the analytical results can be trusted for quality control purposes.
Robustness of the Method
Robustness was also a significant focus of the validation, reflecting the method's reliability under varied experimental conditions. Various studies were conducted to assess the effects of variations in mobile phase composition, flow rates, temperature, and pH. The findings confirmed that the method maintained acceptable performance standards across these variables, with tailing factors for both drugs remaining within the predetermined acceptable limits (2.0 for Artemether and 4.0 for Lumefantrine). This robustness underlines the method's applicability in routine laboratory settings where conditions may vary.
Conclusion
In conclusion, the study by Rajesh et al. has successfully developed a validated RP-HPLC method for the simultaneous estimation of Artemether and Lumefantrine in tablet formulations. The method demonstrates simplicity, rapidity, and reliability, making it suitable for routine quality control analysis in pharmaceutical settings. The findings confirm that the developed method meets the necessary validation parameters, contributing to better analytical practices in the field of pharmaceutical research and ensuring the quality and efficacy of antimalarial therapies.
Original source:
This page is merely a summary which is automatically generated hence you should visit the source to read the original article which includes the author, publication date, notes and references.
A. Rajesh and K. Swapna
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: Development and validation of artemether & lumefantrine in pharmaceutical dosage forms
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
Doi: 10.20959/wjpr201710-9352
Download the PDF file of the original publication
FAQ section (important questions/answers):
What is the main purpose of the study conducted by Rajesh et al.?
The study aimed to develop and validate a simple, reliable method for the simultaneous estimation of Artemether and Lumefantrine in tablet dosage forms using HPLC.
What parameters were validated for the method developed in the study?
The method was validated for system suitability, precision, accuracy, linearity, and robustness to ensure consistent and reliable results for Artemether and Lumefantrine assays.
What are the advantages of using HPLC for drug analysis?
HPLC offers rapid analyses, high sensitivity, improved resolution, and is ideal for low-viscosity substances, making it a preferred method in analytical chemistry.
How does the combination of Artemether and Lumefantrine work in treatment?
Artemether rapidly reduces parasite load, while Lumefantrine prevents recrudescence. This combination improves antimalarial efficacy and reduces resistance development.
What chromatographic conditions were used in the study for the measurement?
The study used a flow rate of 1.5 ml/min, a Symmetry C18 column, and a mobile phase composed of 40% buffer and 60% acetonitrile.
What were the results concerning the precision and accuracy of the developed method?
The method showed a relative standard deviation of less than 2.0% for precision and recovery between 95% and 105% for accuracy, demonstrating its reliable performance.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “Validation of artemether-lumefantrine in pharmaceutical forms.”. 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) Table:
A table is a systematic arrangement of data, often in rows and columns, for easy reading and analysis. In the context of this research, tables summarize experimental results, assay values, and solubility data, providing a clear visual representation that facilitates comparison and understanding of the data collected during assays of Artemether and Lumefantrine.
2) Observation:
Observation involves the act of noting and recording phenomena as part of an experiment. In this research, observations are critical for noting peak shapes, retention times, and other chromatographic results that inform the validity of the assay. Careful observations allow researchers to assess the reliability and accuracy of their methods.
3) Study (Studying):
A study implies a detailed examination and analysis of a subject. In this article, the study focuses on developing and validating a reliable method for the simultaneous estimation of Artemether and Lumefantrine in pharmaceutical forms. This comprehensive approach encompasses experimental setup, testing, data collection, and analysis.
4) Water:
Water is a common solvent and medium for various chemical reactions and extractions. In this study, solubility testing of Artemether and Lumefantrine in different media, including purified water, plays a vital role in understanding the drugs' characteristics and behaviors, which can influence their pharmaceutical formulations and bioavailability.
5) Drug:
A drug is any chemical substance that causes a physiological change in the body when introduced. Artemether and Lumefantrine are antimalarial drugs discussed in this research, and their assay method is critical for ensuring efficacy and safety in medicinal formulations used for treating malaria symptoms and preventing resistance.
6) Activity:
Activity refers to the efficacy or ability of a drug to produce a desired effect, such as eliminating a disease or symptom. The combined activity of Artemether and Lumefantrine in treating malaria is enhanced due to their complementary pharmacokinetic properties, as explored in this research study.
7) Quality:
Quality entails the degree of excellence or standard of a product. In pharmaceutical research, quality is paramount, especially when validating an assay method for drug analysis. The study ensures that the established method meets defined criteria for system suitability, precision, accuracy, and robustness to guarantee reliable results.
8) Substance:
A substance is a particular kind of matter with uniform properties. In this text, substances refer specifically to the active ingredients Artemether and Lumefantrine. Characterization of these substances via their solubility and analytical methods is essential for assessing their viability in drug formulations and therapeutic use.
9) Relative:
Relative refers to a comparative relationship or measurement. In the context of this research, the term relative standard deviation (% RSD) is used to assess the precision of the analytical method. This statistical measure helps in determining the reliability of results by comparing variability within data sets.
10) Life:
Life in this context relates to the biological processes affected by drugs, like Artemether and Lumefantrine. These medications are critical for managing and treating malaria, a life-threatening disease caused by parasites transmitted through bites from infected mosquitoes, emphasizing the importance of effective drug assays.
11) Calculation:
Calculation refers to the mathematical determination of a numerical result based on data. In drug assay methods, several calculations, such as determining the percentage of drug content or recovery rates, are fundamental procedures that validate the analytical method's reliability and accuracy, ensuring proper dosing in pharmaceutical applications.
12) Discussion:
Discussion is the section of a study where results are interpreted and contextualized concerning existing literature. In this article, the discussion reflects on the implications of the assay results for Artemether and Lumefantrine, the efficacy of the developed method, and its potential applications in quality control.
13) Meeting:
Meeting generally refers to the coming together of two or more people to deliberate or discuss. In this study, while not explicitly invoked, the concept highlights the need to align testing methods and standards according to guidelines, ensuring that researchers reach consensus on quality and validation procedures.
14) Nature:
Nature encompasses the inherent characteristics or qualities of substances. In this context, it refers to the chemical and physical behaviors of Artemether and Lumefantrine, which influence their solubility and efficacy as antimalarials, signifying the importance of understanding these natural properties in drug development.
15) Labour (Labor):
Labour refers to the effort required to perform tasks, especially in research and development. In this context, laboratory work involves multiple tasks including method development and validation, requiring skilled personnel and a systematic approach to achieve reliable results in the assay of Artemether and Lumefantrine.
16) Field:
Field can refer to a specific area of study or application, such as analytical chemistry. This research exists within the field of pharmaceutical analysis, focusing on developing validated methods to ensure the effective evaluation of drug formulations like Artemether and Lumefantrine for clinical use.
17) Inci (Imci):
An inch is a unit of measurement that quantifies length. While not a focal point of the study, the relevance in laboratory settings often pertains to equipment dimensions or sample sizes. Precise measurements are crucial in method development to ensure consistency and compliance with established analytical standards.