UV method for azilsartan medoxomil in bulk and formulations.
Journal name: World Journal of Pharmaceutical Research
Original article title: Uv spectrophotometric method for the estimation of azilsartan medoxomil in bulk and pharmaceutical formulations
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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Kunal Sharad Surwade, Ravindra Bhanudas Saudagar
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: Uv spectrophotometric method for the estimation of azilsartan medoxomil in bulk and pharmaceutical formulations
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
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Summary of article contents:
Introduction
Azilsartan medoxomil is an angiotensin II receptor antagonist approved by the U.S. Food and Drug Administration for the treatment of hypertension. This study presents a developed and validated ultraviolet (UV) spectrophotometric method for the accurate determination of Azilsartan medoxomil in bulk and pharmaceutical formulations. The method demonstrates simplicity and sensitivity and offers a reliable means for routine quality control in pharmaceutical applications.
Method Development
The UV spectrophotometric method hinges on measuring the absorbance of Azilsartan medoxomil solutions prepared in a Methanol: Water (50:50 v/v) solvent system at a wavelength of 249 nm. The investigation establishes that Beer’s law is adhered to within the concentration range of 2-20 µg/mL, with a strong correlation coefficient of 0.9996, thereby affirming the method's reliability. The standard stock solution is prepared by dissolving accurately weighed Azilsartan medoxomil in methanol and subsequently diluting it with distilled water, facilitating the creation of a calibration curve that forms the basis of the absorbance measurements.
Method Validation
The validation of the proposed method follows the International Conference on Harmonization (ICH) guidelines, encompassing parameters such as linearity, precision, accuracy, and limits of detection (LOD) and quantification (LOQ). Results indicate that the method is highly precise, demonstrating less than 2% relative standard deviation in replicates for both intraday and interday testing. Furthermore, recovery studies confirmed that the method can accurately quantify Azilsartan medoxomil, with recoveries ranging from 99.9% to 101.8%.
Results and Optical Parameters
The optical parameters derived from the study include a limit of detection of 0.204 μg/mL and a limit of quantification of 0.619 μg/mL. Key regression values such as the slope (0.0493) and intercept (0.0409) demonstrate the method's correlation with Beer’s law, facilitating the inference of drug concentration from absorbance measurements effectively. These results, encapsulated in tabulated form, underscore the method’s utility in consistent and precise drug analysis.
Conclusion
In summary, the developed spectrophotometric method for determining Azilsartan medoxomil's concentration is both sensitive and accurate, making it appropriate for routine quality control in pharmaceutical settings. The comprehensive validation according to ICH guidelines confirms its reliability and reproducibility, ensuring its suitability for consistent use in monitoring drug quality and supporting further research and application in clinical settings.
FAQ section (important questions/answers):
What is Azilsartan medoxomil used for?
Azilsartan medoxomil is an angiotensin II receptor antagonist used to treat hypertension and is approved by the U.S. Food and Drug Administration for managing high blood pressure in adults.
What method was developed for analyzing Azilsartan medoxomil?
A simple, sensitive, and highly accurate ultraviolet spectrophotometric method was developed for estimating Azilsartan medoxomil in bulk and pharmaceutical formulations.
What was the wavelength used for absorbance measurement?
The absorbance of Azilsartan medoxomil solution was measured at 249 nm within the wavelength range of 200-400 nm.
How was the method validated?
The method was validated for accuracy, precision, limit of detection (LOD), and limit of quantification (LOQ) following International Conference on Harmonisation (ICH) guidelines.
What were the findings regarding precision of the method?
The relative standard deviation for absorbance measurements was less than 2%, indicating that the method demonstrates good precision for both intraday and interday analyses.
What are the limits of detection and quantification?
The limit of detection (LOD) was found to be 0.204 μg/mL, while the limit of quantification (LOQ) was determined to be 0.619 μg/mL.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “UV method for azilsartan medoxomil in bulk and formulations.”. 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 this context, 'Drug' refers to Azilsartan Medoxomil, an angiotensin II receptor antagonist used to treat hypertension. The research focuses on accurately measuring the drug's concentration in bulk and pharmaceutical formulations, emphasizing its importance in managing high blood pressure and overall cardiovascular health in patients.
2) Water:
'Water' is a critical solvent in the spectrophotometric method described in the study. The method utilizes a Methanol: Water solution for preparing samples, highlighting water's role in dissolving the drug and ensuring accurate and reproducible measurements in laboratory analyses.
3) Table:
'Table' refers to the structured presentation of data in the study. The research includes several tables summarizing findings, such as precision and accuracy studies. These tables facilitate the clear communication of results, helping readers to quickly comprehend important numerical data supporting the method's validity.
4) Relative:
'Relative' in this context pertains to the standard deviation percentages presented in the precision and accuracy sections of the study. It underscores the relationship between the standard deviation and the mean, providing insight into the variability of measurements in relation to their average value, which is crucial for evaluating method reliability.
5) Study (Studying):
'Study' denotes the systematic investigation into the UV spectrophotometric method for Azilsartan Medoxomil. It encapsulates the research process, methodology, and analysis involved in validating a new approach for drug measurement, essential in ensuring that the results are credible and applicable in pharmaceutical quality control.
6) India:
'India' indicates the geographical and institutional context where the research was conducted. It refers to the KCT’S RGS College of Pharmacy located in Maharashtra, which illustrates the study's academic framework and the relevance of local research to global pharmaceutical practices and regulations.
7) Maharashtra (Maharastra, Maha-rashtra):
'Maharashtra' is a state in India where the research institution is located. Highlighting its significance shows the regional aspect of the study, adding context regarding the standards of pharmaceutical research and the development of quality control methods within the Indian landscape.
8) Measurement:
'Measurement' pertains to the quantification of Azilsartan Medoxomil concentration using UV spectrophotometry in the study. Accurate measurement is vital for determining drug efficacy, ensuring quality in pharmaceuticals, and adhering to regulatory standards for safe and effective patient care in hypertension treatment.
9) Sharad (Sarad):
'Sharad' refers to Kunal Sharad Surwade, the principal author of the study. His involvement signifies the individual contribution to the research and underscores the collaboration within academic settings that leads to innovative methodologies and advances in pharmaceutical analysis and quality control.
10) Nashik:
'Nashik' is a city in Maharashtra, India, where the research institution is based. This geographical mention emphasizes the local framework within which the study is situated, contributing to the understanding of pharmaceutical education and research endeavors that align with industry practices in India.
11) Discussion:
'Discussion' signifies the section in a research paper where results are interpreted and contextualized. It allows authors to elaborate on findings, their implications, and their relation to existing literature, fostering a deeper understanding of the research impact within pharmaceutical sciences and informing future studies.
12) Bhanudasa (Bhanudas, Bhanu-dasa):
'Bhanudas' refers to Bhanudas Saudagar, a co-author involved in the study. His association contributes to the research credibility and emphasizes collaborative authorship, showcasing a collective expertise within the team focused on developing a reliable analytical method for pharmaceutical applications.
13) Quality:
'Quality' indicates the high standards upheld in the study's methodology and analysis. It refers to the significance of ensuring that the methods used for drug measurement are precise, accurate, and reproducible, which is critical for regulatory compliance and patient safety in pharmaceutical manufacturing.
14) Citizen:
'Citizen' refers to the electronic balance used in measuring the drug sample accurately. The importance of having high-quality scientific equipment in research is highlighted, illustrating how precise measurement tools contribute to reliable results and are fundamental in the validation of analytical methods.
15) Blood:
'Blood' in this context relates to the drug's therapeutic use in managing high blood pressure. This connection underscores the importance of Azilsartan Medoxomil in cardiovascular health and its relevance as a medication aimed at controlling and treating hypertension in affected patients.
16) Food:
'Food' denotes the 'U.S. Food and Drug Administration' referenced in the study, which is pivotal for regulating pharmaceutical products. Understanding its role highlights the importance of adhering to established standards for safety and efficacy in drug development and approval processes to protect public health.
17) Salt (Salty):
'Salt' refers to the final product form of Azilsartan Medoxomil, specifically as a 'monopotassium salt.' This aspect emphasizes the chemical nature of the drug and its formulation as a salt compound, which is crucial for drug absorption and pharmacological activity in the body's systems.
Other Science Concepts:
Discover the significance of concepts within the article: ‘UV method for azilsartan medoxomil in bulk and formulations.’. Further sources in the context of Science might help you critically compare this page with similair documents:
High blood pressure, Research article, Satisfactory result, Analytical grade chemicals, Limit of detection, Limit of quantification, Calibration curve, Limit of Detection (LOD), Limit of Quantification (LOQ), Intraday precision, Interday precision, Analytical Procedure, Percentage recovery, Recovery studies, Method validation, Absorbance measurement, Beer's law, Precision study, ICH Guideline.