Etoposide validation and recovery using RP-HPLC and UV-Vis.
Journal name: World Journal of Pharmaceutical Research
Original article title: Validation, estimation and recovery studies of etoposide in bulk and injectable dosage forms using rp-hplc and uv-visible spectroscopy
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.
Deepak Tripathi, Mr. Ravinder Mohanty, Hemant Bhardwaj, Jatin Jaiswal
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: Validation, estimation and recovery studies of etoposide in bulk and injectable dosage forms using rp-hplc and uv-visible spectroscopy
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
Download the PDF file of the original publication
Summary of article contents:
Introduction
Etoposide is a potent chemotherapy drug derived from podophyllotoxin, known for its ability to inhibit DNA synthesis, particularly in cells during the G2 phase of the cell cycle. The drug functions by causing DNA breaks through the inhibition of the enzyme DNA topoisomerase II. The presented study emphasizes the development and validation of a reverse phase high performance liquid chromatography (RP-HPLC) method for accurately determining Etoposide levels in bulk and injectable dosage forms. The method aims to provide reliability in quantifying Etoposide without interference from excipients in the formulation, ensuring precise and accurate analysis.
Method Development and Validation
A significant aspect of the research was the robust methodology utilized for the analysis of Etoposide. The RP-HPLC method was executed using a Zorbex NH2 column, with a mobile phase consisting of 0.030 M sodium acetate buffer at pH 4.0 and acetonitrile in a ratio of 70:30. The flow rate was maintained at 1.2 ml/min, and detection was performed at a wavelength of 254 nm. Calibration was linear, with concentrations ranging from 100 ppm to 300 ppm, yielding a correlation coefficient of 0.9911. The accuracy of the method was confirmed by recovery studies, recording recoveries varying between 98.1% to 102.3%.
Precision and System Suitability
Precision of the developed RP-HPLC method was evaluated through the relative standard deviation (RSD) of samples across different days, showing values under 0.5% for in-day preparations and a cumulative RSD of no more than 2% across 18 injections. System suitability parameters were also assessed by checking the tailing factor and theoretical plates, leading to favorable conditions that exhibited the method's reliability. The results indicated a good system suitability with a tailing factor of 1.16 and theoretical plates of 3623.55, reinforcing the method's effectiveness for routine analysis.
Detection Limits
The study further established the limits of detection (LOD) and quantification (LOQ) for Etoposide, defining the LOD as 2 ppm and the LOQ as 6 ppm. These findings suggest that the method is sensitive enough for accurate analysis of Etoposide at relatively low concentrations. The methodology demonstrated high sensitivity and reliability, making it suitable not only for the analysis of bulk quantities but also for quality control in injectable formulations.
Conclusion
In conclusion, the RP-HPLC method developed for analyzing Etoposide is validated for its sensitivity, precision, and accuracy, making it a compatible choice for routine quality control in pharmaceutical formulations. The study showcases that the proposed method can effectively determine the concentration of Etoposide without interference, ensuring the safe and effective use of the drug in clinical settings. The positive results indicate that this method can be reliably implemented in both research and commercial laboratories for ongoing analysis of Etoposide and potentially similar compounds.
FAQ section (important questions/answers):
What is the purpose of the RP-HPLC method developed?
The RP-HPLC method is designed for the precise estimation of Etoposide in bulk and injectable dosage forms, ensuring accurate quantification without interference from excipients.
What are the key components of the mobile phase used?
The mobile phase consists of a 0.030 M Sodium acetate buffer at pH 4.0 mixed with Acetonitrile in a 70:30 ratio, facilitating effective separation of Etoposide.
How was the linearity of the calibration curve established?
Linearity was determined through concentrations ranging from 100 to 300 ppm, resulting in a correlation coefficient of 0.9911, confirming the method's reliability for quantification.
What were the recovery results for the Etoposide method validation?
The recovery studies yielded values of 101.2%, 98.1%, and 102.3% at levels of 50%, 100%, and 150%, respectively, indicating high accuracy of the method.
What is the Limit of Detection (LOD) and Limit of Quantification (LOQ)?
The LOD for Etoposide is 2 ppm, while the LOQ is 6 ppm, indicating the method's sensitivity and capability to detect low concentrations effectively.
What temperature stability was found for Etoposide during the study?
The standard Etoposide was stable for up to 12 hours, while the sample remained stable for 24 hours at ambient temperature, ensuring reliable analysis.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “Etoposide validation and recovery using RP-HPLC and UV-Vis.”. 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) Water:
Water is a crucial solvent in analytical chemistry, particularly in High-Performance Liquid Chromatography (HPLC). In this study, HPLC-grade water is paired with acetonitrile to create a mobile phase for the separation and analysis of Etoposide, ensuring the consistency and accuracy of the results obtained in the experiments.
2) Table:
Tables are essential for organizing and presenting data clearly in scientific research. In this document, tables summarize results like linearity, precision, and recovery studies, making it easier for readers to interpret the findings of the study on Etoposide and understand its analytical methodology effectively.
3) Drug:
A drug refers to a substance used for medical treatment. In this context, Etoposide is a chemotherapeutic agent with properties that inhibit DNA synthesis in cancer cells. The research focuses on developing an accurate HPLC method to quantify this drug in various formulations, emphasizing its clinical relevance.
4) India:
India is highlighted as the country where this research took place, particularly in Uttarakhand. The mention of Indian institutions and companies emphasizes the contribution of Indian researchers to pharmaceutical sciences and the broader global efforts in drug analysis and validation methodologies.
5) Study (Studying):
A study represents a systematic investigation into a specific subject. This research outlines the development and validation of a method for quantifying Etoposide. The rigorous approach showcases the application of scientific principles in pharmaceutical analysis, demonstrating the study’s importance in ensuring drug quality and efficacy.
6) Noise:
Noise, in analytical contexts, refers to random fluctuations that can affect measurement accuracy. The study mentions signal-to-noise ratios when discussing limits of detection and quantification. Minimizing noise is critical in achieving precise results in chromatography, enhancing the reliability of the findings related to Etoposide.
7) Pharmacological:
Pharmacological properties pertain to the effects a drug has on biological systems. Etoposide is noted for its ability to inhibit DNA synthesis, making it a potent chemotherapeutic agent. Understanding its pharmacological aspects is vital for ensuring its effective and safe use in cancer treatment protocols.
8) Performance:
Performance refers to the effectiveness and efficiency of the proposed HPLC method in analyzing Etoposide. The study assesses method performance through validation parameters such as precision, accuracy, and recovery, underscoring the method's reliability for routine quality control in pharmaceutical applications.
9) Discussion:
Discussion in research refers to the interpretation and implications of study findings. This section allows the authors to contextualize their results, comparing them with existing literature, explaining the significance of the findings, and suggesting practical applications or future research directions pertinent to Etoposide analysis.
10) Relative:
Relative refers to a comparison among specific metrics, often in relation to one another. In this study, relative standard deviation (RSD) is used to assess the consistency and precision of measurement results for Etoposide. Such comparisons are crucial for establishing method reliability and quality assurance in drug analysis.
11) Quality:
Quality emphasizes the standard of the analytical method developed in this study. Ensuring high-quality results in drug analysis is paramount for regulatory compliance and therapeutic efficacy. The study demonstrates how detailed validation ensures the reliability and safety of Etoposide in pharmaceutical preparations.
12) Science (Scientific):
Science forms the foundation of the methodologies used in this research, emphasizing systematic observation, experimentation, and validation. This study showcases the application of scientific principles in developing analytical techniques that ensure drug safety and effectiveness, thus contributing to the field of pharmaceutical sciences.
13) Jati (Jatin):
Jatin refers to one of the authors of the study, highlighting the collaborative nature of scientific research. The inclusion of diverse researchers contributes to a comprehensive understanding of methodologies and findings, reflecting the importance of teamwork in advancing pharmaceutical sciences and drug analysis.
14) Medi:
Medi alludes to VHB Mediscience Limited, the organization associated with the research. This connection underscores the role of industry collaboration in advancing pharmaceutical research, particularly in method development and validation. Such partnerships bridge academic knowledge with practical applications in drug formulation and quality assurance.
Other Science Concepts:
Discover the significance of concepts within the article: ‘Etoposide validation and recovery using RP-HPLC and UV-Vis.’. Further sources in the context of Science might help you critically compare this page with similair documents:
Limit of detection, Limit of quantification, Environmental temperature, Chromatographic parameters, Calibration curve, Recovery studies, Method validation.