RP-HPLC method for diacerein and glucosamine estimation.
Journal name: World Journal of Pharmaceutical Research
Original article title: Rp-hplc method development and validation for simultaneous estimation of diacerein and glucosaminesamine in bulk and pharmaceutical dosage form
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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T. Sriveena, A. Srividya, A. Ajitha and V. Uma Maheswara Rao
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: Rp-hplc method development and validation for simultaneous estimation of diacerein and glucosaminesamine in bulk and pharmaceutical dosage form
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 focused on the development and validation of a reverse phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of Diacerein and Glucosamine in pharmaceutical dosage forms. The research aimed to establish a precise, rapid, accurate, and specific technique to enable effective analysis of these compounds, which are essential in the treatment of joint diseases such as osteoarthritis. The study adhered to ICH guidelines for method validation, examining parameters such as linearity, accuracy, precision, and robustness.
Chromatographic Method Development
The optimized RP-HPLC method used an ODS C18 column under specific chromatographic conditions. The mobile phase consisted of a mixture of Triethylamine (pH 4), Methanol, and Acetonitrile in a volumetric ratio of 50:10:40, with a flow rate of 1 ml/min at a detection wavelength of 250 nm. The retention times observed for Diacerein and Glucosamine were 2.242 minutes and 3.678 minutes, respectively, allowing for the successful separation of these compounds within a total analysis time of less than 10 minutes. The method established by the authors demonstrated good resolution and reliability, achieving an excellent correlation coefficient greater than 0.999 for both compounds.
Validation Parameters and Results
Method validation revealed that the RP-HPLC technique was robust in terms of accuracy and precision. The limits of detection (LOD) for Diacerein and Glucosamine were determined to be 19.3 µg/ml and 1.05 µg/ml, respectively, while the limits of quantification (LOQ) were 58.6 µg/ml for Diacerein and 3.19 µg/ml for Glucosamine. Recovery studies conducted at various concentrations indicated that the assay method could accurately determine the amounts of both compounds in commercial tablets, achieving recovery rates of around 99%. The method's reliability was evidenced by low % RSD values, confirming the precision of both intra-day and inter-day analyses.
Practical Application and Benefits
The developed RP-HPLC method was successfully applied to analyze marketed formulations, ensuring that the quality control measures for Diacerein and Glucosamine were maintained. The specific isolation of these compounds in the presence of common excipients indicated that the method is suitable for routine laboratory analysis. The study emphasized the significance of having a reliable analytical method that can accurately quantify these critical components in pharmaceutical preparations, which can lead to effective management and treatment of osteoarthritis-related ailments.
Conclusion
The newly developed RP-HPLC method offers a practical, efficient, and accurate approach for the simultaneous estimation of Diacerein and Glucosamine in tablet form. This research not only contributes to the field of pharmaceutical analysis but also holds promise for future applications, particularly in the quality control of pharmaceutical products. The method's high degree of accuracy and specificity ensures that it can be integrated into standard laboratory practices for routine analysis, supporting the ongoing need for effective treatments in joint health management. The authors expressed gratitude to the institutions and laboratories that facilitated this study, underlining the collaborative effort necessary for successful research outcomes.
FAQ section (important questions/answers):
What is the purpose of the developed RP-HPLC method?
The method was developed for the simultaneous estimation of Diacerein and Glucosamine in pharmaceutical dosage forms, ensuring precision, accuracy, and specificity.
What are the main components and conditions used in the method?
The RP-HPLC method uses an ODS (C18) column with a mobile phase of Triethylamine pH4, Methanol, and Acetonitrile in a 50:10:40 ratio, at a flow rate of 1 ml/min and detection wavelength at 250 nm.
What were the retention times for Diacerein and Glucosamine?
The retention times were 2.242 minutes for Diacerein and 3.678 minutes for Glucosamine, allowing effective separation within a total run time of 6 minutes.
What validation parameters were assessed for the method?
The method was validated for linearity, accuracy, precision, limit of detection, limit of quantification, ruggedness, and robustness according to ICH guidelines.
How reliable is the accuracy of the method?
The accuracy was confirmed with recovery studies, yielding results within 98-102%. Diacerein and Glucosamine showed recoveries of 99%, indicating a reliable analytical method.
What are the limits of detection and quantification for the drugs?
The limit of detection for Diacerein is 1.05 µg/ml and for Glucosamine is 19.3 µg/ml. The limit of quantification is 3.19 µg/ml for Diacerein and 58.6 µg/ml for Glucosamine.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “RP-HPLC method for diacerein and glucosamine estimation.”. 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:
The term 'Table' in this context refers to the organized presentation of data, which facilitates easy understanding of the results obtained from analytical methods like HPLC. Tables summarize findings such as linearity, recovery percentages, statistical evaluations, and method validation outcomes, serving as essential references in scientific reporting and analysis.
2) Drug:
The word 'Drug' denotes a chemical substance used for medical treatment, prevention, or diagnosis of diseases. In the document, it specifically pertains to Diacerein and Glucosamine, which are utilized for osteoarthritis management. Understanding the pharmacological function of these drugs is crucial for researchers and healthcare professionals.
3) India:
India is the country where the research was conducted, highlighting the significance of local pharmaceutical advancements. The presence of numerous pharmaceutical colleges and research laboratories contributes to developing efficient analytical methods and drug formulations, reflecting India's role in the global pharmaceutical landscape and its contribution to healthcare solutions.
4) Water:
'Water' is mentioned concerning the solubility of drugs. The solubility of pharmaceutical compounds is vital for their bioavailability. In drug formulation, understanding how different substances dissolve in water impacts how they are absorbed in the body, making water a critical component of pharmaceutical research and formulation.
5) Measurement:
The term 'Measurement' pertains to the quantitative assessment of drug concentrations through HPLC. Accurate measurement is fundamental in pharmacology, ensuring that dosages are effective and safe. The validation of measurement techniques reflects the reliability of analytical results, which is crucial for compliance with pharmacological standards.
6) Quality:
'Quality' refers to the reliability and consistency of drug formulations. In pharmaceutical research, maintaining high quality in product development ensures safety, efficacy, and compliance with regulatory standards. The methods described in the study aim to ensure the quality of Diacerein and Glucosamine in pharmaceutical applications.
7) Noise:
'Noise' in the context of HPLC refers to background signals that can interfere with the measurement of drug concentrations. Reducing noise is crucial to enhance the sensitivity and accuracy of analytical methods, ensuring clearer identification of drug peaks during chromatography, thus contributing to more reliable data.
8) Pain:
'Pain' relates to the primary condition that Diacerein and Glucosamine aim to alleviate, particularly in osteoarthritis. Understanding the mechanisms by which these drugs relieve pain is essential for evaluating their therapeutic efficacy. This highlights the importance of research in developing effective pain management solutions.
9) Study (Studying):
'Study' refers to the research conducted to develop and validate the RP-HPLC method for estimating Diacerein and Glucosamine. This term encompasses experimental design, data collection, and analysis, emphasizing the importance of systematic research in advancing pharmaceutical methodologies and improving drug formulations.
10) Road:
'Road' indirectly signifies the journey of pharmaceutical research and development, particularly in India where the study was conducted. It symbolizes the progress and evolution of drug formulation techniques and analytical methods, leading to innovations that enhance patient treatment and healthcare solutions.
11) Performance:
'Performance' relates to the efficacy of the developed HPLC method in accurately estimating drug concentrations. Effective performance is vital for ensuring that analytical methods meet expected standards within the pharmaceutical industry, which relies on precise measurement for quality assurance in drug development.
12) Reliability:
'Reliability' indicates the trustworthiness of the analytical method used in the study. It reflects how consistently the method produces accurate results across various conditions. High reliability is essential in pharmaceuticals to ensure that drug formulations are safe, effective, and conform to regulatory requirements.
13) Discussion:
'Discussion' in a research context presents an analysis of results, interpretation of data, and comparison with existing literature. It provides insights into the implications of the findings, contributing to the broader understanding of pharmaceutical sciences and informing future research directions.
14) Science (Scientific):
'Scientific' denotes the systematic and empirical approach taken in the study, emphasizing the use of validated methods and adherence to guidelines. This term underscores the importance of scientific rigor in pharmaceutical research, ensuring that findings contribute positively to the field of drug development.
15) Medicine:
'Medicine' refers to the field concerned with health and the treatment of disease. This document discusses the pharmaceutical applications of Diacerein and Glucosamine, showcasing their role as therapeutic agents in managing osteoarthritis, thus contributing to improved healthcare outcomes through effective medication.
16) Swelling:
'Swelling' pertains to the inflammatory response often associated with osteoarthritis, where pain and swelling are key symptoms. Understanding the role of Diacerein in addressing these symptoms is crucial for evaluating its therapeutic effectiveness and overall impact on joint health in patients.
17) Gujarat:
Gujarat is the state in India where the HPLC system was sourced, highlighting the geographical aspect of pharmaceutical research and development. The vibrant pharmaceutical industry in Gujarat plays a critical role in advancing drug formulation methodologies, impacting local and global health solutions.
18) Disease:
'Disease' relates to the pathological condition being targeted in the study, specifically osteoarthritis. Understanding the mechanisms of the disease guides the development and efficacy of treatment strategies. The focus on effective drugs underscores the importance of research in improving life quality for individuals afflicted by diseases.
19) Repair:
'Repair' signifies the process of healing or restoration of cartilage and joint function, particularly regarding the role of Glucosamine in joint rehabilitation. Understanding how drugs facilitate repair processes is fundamental to developing effective therapies in managing joint-related disorders.
20) Purity:
'Purity' indicates the quality standard of pharmaceutical compounds, which is vital for ensuring that the drugs are free from contaminants. High purity levels are essential for safety and efficacy. The study emphasizes the need for methods to verify the purity of Diacerein and Glucosamine in formulations.
21) Sugar:
'Sugar' in this context may refer to 'Glucosamine,’ an amino sugar used in treating osteoarthritis. It highlights the compound's biochemical role in cartilage health. Understanding the structural characteristics of glucose-based compounds aids in grasping their functional significance in pharmacological therapies.
22) Sura (Shura):
Sura refers to Sura Labs Pvt Ltd, the organization that provided samples of Diacerein and Glucosamine for the study. Support from pharmaceutical companies is critical in research, allowing for the practical evaluation of analytical methods and the development of effective healthcare products.
23) Beta:
'Beta' here may refer to the beta form of interleukin-1 involved in the inflammatory response related to osteoarthritis. Understanding interleukin's role is essential in targeting the inflammatory processes with pharmacological therapies, illustrating the biological mechanisms behind drug actions in joint diseases.
24) Ting:
'Ting' does not appear to be clearly contextualized within the document text; it may refer to a term or abbreviation not easily linked to pharmaceutical or analytical discussions. Clarification or definition may depend on specific contextual usage not captured in the content provided.
Other Science Concepts:
Discover the significance of concepts within the article: ‘RP-HPLC method for diacerein and glucosamine estimation.’. Further sources in the context of Science might help you critically compare this page with similair documents:
High performance liquid chromatography, Chromatogram, Retention time, Mobile phase, Chromatographic separation, Limit of detection, Limit of quantification, Sample preparation, Specificity, RP-HPLC Method, Recovery studies, Flow rate, Method validation, Pharmaceutical dosage form, Limit of quantitation, Tablet dosage form, Standard calibration curve, Spectrophotometric analysis, Recovery experiment, Chromatographic condition, Standard solution, Repeatability, ICH Guideline, Reversed-phase C18 column.