RP-HPLC method for quantifying dexamethasone in herbal products.
Journal name: World Journal of Pharmaceutical Research
Original article title: Rp-hplc method development for the quantitative determination of dexamethasone in herbal formulation
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.
This page presents a generated summary with additional references; See source (below) for actual content.
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.
Venkata Sairam K, J C Thejaswini, M V Prudhvi Raju, R S Chandan,B M Gurupadayya, K Mruthunjaya
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: Rp-hplc method development for the quantitative determination of dexamethasone in herbal formulation
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
Copyright (license): WJPR: All rights reserved
Download the PDF file of the original publication
Summary of article contents:
Introduction
The study presented in this article focuses on the development of a reliable, sensitive method for the quantitative determination of dexamethasone, a corticosteroid, in herbal formulations. Herbal medicines are increasingly favored by consumers for their perceived safety and natural origins. However, the presence of synthetic adulterants like dexamethasone can pose serious health risks, particularly given their potential to induce unwanted side effects and herb-drug interactions. This research aims to address the lack of sufficient methods for detecting such adulteration in herbal products through a reverse phase high-performance liquid chromatography (RP-HPLC) technique.
Method Development and Optimization
A significant aspect of the study is the methodology adopted for the RP-HPLC analysis. The authors utilized a cyano column in conjunction with a mobile phase comprising 0.1% ortho phosphoric acid and acetonitrile (80:20 v/v) at a flow rate of 1.2 mL/min. This configuration allowed for the effective separation of dexamethasone from other components present in the herbal formulation. The method was optimized for retention time, which resulted in a consistent elution time of 8.8 minutes. The analytical conditions were carefully validated, showing a linear response for dexamethasone concentrations ranging from 5 to 60 µg/mL, demonstrating the method's efficiency and reliability for detecting this adulterant.
Method Validation and Accuracy
The validation process for the proposed HPLC method included a comprehensive assessment based on parameters such as system suitability, linearity, precision, and accuracy. The system suitability analysis yielded favorable results, with the calculated retention time, theoretical plates, and tailing factors indicating the method's robustness. Accuracy was evaluated through recovery studies, revealing that the method maintained a percentage recovery rate around 95%, affirming its reliability in quantitative analysis. Additionally, the limits of detection (LOD) and quantification (LOQ) were established to be 129 ng and 388 ng, respectively, emphasizing the method's sensitivity.
Practical Application and Robustness
The method was applied to actual herbal formulations, demonstrating its practical efficiency in identifying and quantifying dexamethasone in spiked samples. Extraction procedures, including liquid-liquid extraction, ensured the effective removal of the drug from the herbal component, followed by HPLC analysis. Results indicated no significant interference from the herbal matrix during detection, affirming the method's robustness. Further evaluations into method ruggedness — examining variations in reagent lots— confirmed the repeatability and reproducibility of the process, critical for routine analysis in quality control laboratories.
Conclusion
The developed RP-HPLC method for the detection of dexamethasone in herbal formulations offers a fast, sensitive, and accurate approach for ensuring the safety and quality of these products. The research effectively highlights the dangers posed by the presence of synthetic adulterants and underscores the importance of developing efficient analytical techniques for their detection. Given the comprehensive validation and successful applications demonstrated in this study, the method stands as a valuable tool in monitoring the integrity of herbal medicines, ultimately contributing to public health safety.
FAQ section (important questions/answers):
What is the purpose of developing this HPLC method?
The method aims to quantitatively determine dexamethasone, which is commonly used as an adulterant in herbal formulations. This detection is important to ensure the safety and efficacy of herbal medicines.
What were the key components of the mobile phase used?
The mobile phase consisted of 0.1% ortho phosphoric acid and acetonitrile in an 80:20 v/v ratio. This combination was essential for achieving efficient separation and analysis of dexamethasone.
What was the retention time for dexamethasone in the developed method?
The retention time for dexamethasone in the HPLC analysis was found to be 8.8 minutes, allowing for the clear identification of the compound during the analysis.
How was the validity of the method confirmed?
Method validation was conducted by assessing parameters like linearity, precision, accuracy, and limits of detection and quantification, complying with International Conference on Harmonization (ICH) guidelines.
What is the recovery percentage achieved in the spiking experiment?
The recovery percentage for dexamethasone in the herbal formulation spiking experiments was found to be around 95.67%, indicating a high accuracy of the developed analytical method.
Can this method be used for routine analysis of herbal formulations?
Yes, the developed HPLC method is simple, sensitive, accurate, and reproducible, making it suitable for routine quantitative determination of dexamethasone in herbal formulations.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “RP-HPLC method for quantifying dexamethasone in herbal products.”. 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:
In the context of this study, 'Drug' refers to dexamethasone, a synthetic corticosteroid used as an adulterant in herbal formulations. Understanding its role is crucial for ensuring the safety and efficacy of herbal products, especially as various herbal remedies can be contaminated with synthetic drugs, leading to potential health risks for consumers.
2) Venkata (Vemkata):
This name refers to the lead author, Venkata Sairam K, who contributed significantly to the research on the development of an HPLC method for detecting dexamethasone in herbal formulations. The author's expertise lends credibility to the findings and is indicative of the collaborative academic effort in pharmaceutical research.
3) Water:
Water is a fundamental solvent in this study, used in the preparation of samples and as a part of the mobile phase in the HPLC method. It is essential in the extraction process to dissolve plant materials, allowing for the analysis of potential adulterants like dexamethasone in herbal medicines.
4) Table:
Tables in the study are utilized to systematically present quantitative data derived from experiments. These may include system suitability parameters, recovery studies, and linearity data, making complex data easy to understand and compare. Tables are a vital part of scientific communication, aiding in the synthesis of information.
5) Study (Studying):
The term 'Study' encapsulates the entire research process undertaken to develop and validate an HPLC method for detecting dexamethasone. It includes meticulous procedures, data collection, and analysis that contribute to a greater understanding of herbal formulation safety, addressing concerns regarding adulteration and its public health implications.
6) Medicine:
In this context, 'Medicine' pertains to herbal formulations that are often perceived as safe alternatives to conventional pharmaceuticals. However, the potential for adulteration with synthetic drugs like dexamethasone raises significant concerns regarding efficacy and safety, necessitating rigorous analytical methods to ensure consumer protection.
7) India:
India is the geographical context of this research, emphasizing the country's rich tradition in herbal medicine as well as the challenges faced due to adulteration. The study aims to address these local and global issues concerning the integrity of herbal products consumed by the population.
8) Mysore:
Mysore, where JSS College of Pharmacy is located, represents the specific academic and research environment in which this study was conducted. This locale is significant for its contributions to pharmaceutical education and research, particularly as it pertains to the analysis of herbal formulations.
9) Powder:
The term 'Powder' relates to the herbal medicines studied. Ground herbal products may serve as the matrix for dexamethasone detection. Understanding the physical form of these medicines is crucial for the method development, as extraction processes depend on how the herbs are processed and formulated.
10) Performance:
Performance in this study refers to the operational efficiency and effectiveness of the developed HPLC method. Measurements of performance can include analytical parameters such as linearity, precision, and reliability, indicating how well the method can produce consistent and accurate results in detecting dexamethasone.
11) Reliability:
Reliability is a critical aspect of the analytical methods employed, ensuring that the findings are consistent and reproducible across multiple trials. For the results to be deemed valid within the pharmaceutical community, the method must consistently identify and quantify dexamethasone accurately in samples.
12) Discussion:
The 'Discussion' section of the study interprets and contextualizes the data obtained, linking it back to existing literature on dexamethasone adulteration in herbal medicines. This part is crucial for highlighting the significance of findings, implications for public health, and potential future research directions.
13) Developing:
Developing a method signifies the rigorous process of designing, refining, and validating the analytical approach taken to detect dexamethasone. This encompasses various aspects such as optimization of chromatographic conditions and ensuring that the method meets the necessary validation criteria established by regulatory guidelines.
14) Karnataka:
Karnataka is the Indian state where the study took place, indicating the regional relevance of the research. The use of herbal remedies in this region is prominent, highlighting the importance of ensuring their safety and authenticity amidst concerns of synthetic drug contamination, which is pertinent across India.
15) Relative:
Relative in this context refers to the comparative analysis of dexamethasone concentration in herbal formulations. By measuring relative amounts, researchers can determine the extent of adulteration and its implications, providing insight into the prevalence of synthetic drugs in these herbal medicines.
16) Line:
The term 'Line' pertains to the linear relationship established during method validation between dexamethasone concentration and the peak area response in HPLC analysis. This linearity is crucial for accurate quantification, ensuring that the results can be reliably interpreted and used for regulatory or therapeutic purposes.
Other Science Concepts:
Discover the significance of concepts within the article: ‘RP-HPLC method for quantifying dexamethasone in herbal products.’. Further sources in the context of Science might help you critically compare this page with similair documents:
Herbal formulation, Limit of detection, Limit of quantification, Standard deviation, HPLC Method, Calibration curve, Limit of Detection (LOD), Percentage recovery, RP-HPLC Method, Method validation, Routine Analysis, Quantitative determination, Linear concentration range, ADULTERATION OF HERBAL DRUGS, Synthetic drug, Chromatographic parameter.