Spectrophotometric method for estimating anastrozole in bulk/tablets.
Journal name: World Journal of Pharmaceutical Research
Original article title: Development and validation of spectrophotometric method for estimation of antineoplastic agent anastrozole in bulk and tablet 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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Original source:
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Mrityunjay Banerjee, Susanta Kumar Behera and Sujit Kumar Sahu
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: Development and validation of spectrophotometric method for estimation of antineoplastic agent anastrozole in bulk and tablet dosage form
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
Doi: 10.20959/wjpr201813-12556
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Summary of article contents:
Introduction
Anastrozole is a nonsteroidal aromatase inhibitor used primarily in the treatment of estrogen receptor-positive breast cancer in postmenopausal women. This research presents a validated UV-spectrophotometric method for the estimation of Anastrozole in bulk and tablet dosage forms using 1N HCl as a solvent. The study was conducted in accordance with International Conference on Harmonization (ICH) guidelines, focusing on accuracy, precision, and linearity, among other factors, to establish a reliable analytical method suitable for routine laboratory use.
Method Development and Validation
The study involved the development of a UV spectrophotometric method in which the maximum absorbance (λmax) of Anastrozole was identified at 205.9 nm. The calibration curve for the drug was established within the concentration range of 8-18 µg/ml, exhibiting a high correlation coefficient of 0.999. Validation of the method demonstrated a percentage recovery of Anastrozole between 99.80% and 100.10%, confirming the method’s accuracy and precision. This aspects indicate that the simple UV method can effectively quantify Anastrozole in various formulations.
Analysis of Tablet Samples
The analysis involved preparing standard stock solutions and using them to construct a calibration curve. For the analysis of commercial formulations, Anastrozole tablets were accurately weighed, dissolved in 1N HCl, and sonicated. The absorbance was measured at 205.9 nm, and the concentration of the drug in the tablets was determined using the regression equation derived from the calibration curve. The results revealed that the formulation's drug content was precise, with the amount obtained closely matching the labeled amount, further validating the method's efficacy.
Precision and Recovery Studies
To ensure method reliability, precision studies were conducted in both intraday and interday variations, showcasing that results remained consistent across multiple trials. Recovery studies were also performed by adding known quantities of the standard drug to previously analyzed tablet samples, showing high recovery rates across different concentrations. These findings confirmed high repeatability and reproducibility of the proposed method, establishing its utility in real-world applications for drug analysis.
Conclusion
In conclusion, the developed UV-spectrophotometric method for the estimation of Anastrozole is straightforward, precise, and accurate, with an appropriate sensitivity for routine analysis in quality control laboratories. The study successfully demonstrated that the method can be applied to both bulk samples and pharmaceutical formulations, proving to be free from interference by excipients present in the formulations. As a result, this method can be confidently utilized for monitoring Anastrozole in clinical and quality assurance settings, facilitating better management of breast cancer therapies.
FAQ section (important questions/answers):
What is the purpose of the developed spectrophotometric method?
The method is designed for the estimation of Anastrozole in bulk and tablet dosage forms, providing a simple, rapid, precise, and accurate approach for its analysis in pharmaceutical applications.
What was the maximum absorbance wavelength (λmax) for Anastrozole?
The maximum absorbance wavelength (λmax) for Anastrozole was determined to be 205.9 nm, which was used for the analysis in the developed method.
How was the accuracy of the method validated?
The method's accuracy was validated according to ICH guidelines, with percentage recoveries of Anastrozole ranging from 99.80% to 100.10%, indicating high accuracy and reliability.
What is the concentration range obeyed by Beer’s Law for Anastrozole?
The concentration range that obeyed Beer’s Law for Anastrozole was found to be 8-18 µg/ml, demonstrating the linearity and reliability of the method within this range.
What types of formulations were analyzed using this method?
The developed method was successfully used to analyze Anastrozole content in commercial tablet formulations and bulk mixtures to determine their drug content accurately.
What were the limits of detection (LOD) and quantitation (LOQ)?
The limit of detection (LOD) was 0.0980 µg/ml, and the limit of quantitation (LOQ) was 0.3267 µg/ml, indicating the method's sensitivity for analyzing Anastrozole.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “Spectrophotometric method for estimating anastrozole in bulk/tablets.”. 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:
The term 'Drug' refers to Anastrozole, a nonsteroidal aromatase inhibitor used in the treatment of breast cancer. The study focuses on the development of a UV spectrophotometric method for accurately measuring the concentration of this drug in bulk and tablet formulations, emphasizing its significance in therapeutic applications.
2) Table:
In the context of the study, 'Table' refers to the organized presentation of experimental data, including the calibration curve, the analytical results from tablet formulations, and precision studies. These tables facilitate comparisons, evaluations, and clarifications of the data, playing a vital role in the validation and documentation of the analytical method.
3) Disease:
'Disease' pertains to conditions like breast cancer, for which Anastrozole is indicated. The research highlights the importance of accurate measurement of the drug in managing patients with estrogen receptor-positive breast cancer, emphasizing the critical need for effective treatment options in oncological practice.
4) Cancer:
'Cancer' specifically denotes breast cancer, the focus of the study analyzing Anastrozole's efficacy. The introduction of the drug presents it as an essential option for adjuvant therapy, illustrating the urgent need for reliable measurement methods to enhance patient outcomes and research surrounding oncological therapies.
5) India:
'India' signifies the geographic and cultural context of this study. The method developed for measuring Anastrozole is conducted within an Indian institution, underscoring the importance of local pharmaceutical research capabilities in addressing public health concerns relevant to the population, particularly concerning cancer treatment.
6) Developing:
'Developing' signifies the ongoing process of creating a simple and cost-effective UV spectrophotometric method for estimating Anastrozole. This aspect of the study demonstrates the researchers' commitment to improving analytical techniques, thereby enhancing the quality and reliability of pharmaceutical formulations for better healthcare practices.
7) Cuttack:
'Cuttack' refers to the location of the Institute of Pharmacy and Technology where the research was conducted. This city plays a role in the development of pharmaceutical knowledge and expertise in India, contributing to advancements in drug analysis and improving healthcare outcomes within the region.
8) Kumar:
'Kumar' denotes one of the authors, Susanta Kumar Behera, who contributed to the study. The inclusion of his name reflects the collaborative effort among researchers, indicating shared knowledge and expertise essential for the study’s design, methodology, and validation process in establishing a robust analytical method.
9) Study (Studying):
'Study' represents the comprehensive research aimed at validating a spectrophotometric method for Anastrozole. It encompasses experimental design, methodology, data collection, and analysis, emphasizing the research's significance and contributions to the fields of pharmaceutical sciences and clinical applications in cancer therapies.
10) Food:
'Food' is relevant as Anastrozole can be taken with or without food. Understanding the interaction between the drug and dietary influences assists healthcare professionals in providing adequate patient instructions, promoting proper adherence to treatment regimens, and potentially improving the drug’s therapeutic effectiveness.
11) Measurement:
'Measurement' pertains to the quantification of Anastrozole concentration, highlighting the precision and reliability of the developed method. Accurate measurement is crucial for ensuring appropriate dosing, regulatory compliance, and effectiveness of the drug in treating patients with breast cancer, strengthening public health initiatives.
12) Discussion:
'Discussion' refers to the section of the research paper where the results are interpreted and contextualized. This part provides insights into the implications of the study findings, addresses potential limitations, and suggests areas for further investigation, contributing to the overall understanding of Anastrozole's analytical methodologies.
13) Relative:
'Relative' in this context can refer to comparative aspects, particularly in the precision and accuracy of the measurement method. This term helps to gauge the performance against established standards, ensuring that the analytical method meets the necessary criteria for reliable pharmaceutical evaluation.
14) Quality:
'Quality' relates to the consistency, accuracy, and reliability of the developed UV spectrophotometric method for analyzing Anastrozole. The focus on quality assurance in pharmaceutical measurements ensures that the drug formulations meet regulatory standards, ultimately leading to enhanced safety and efficacy in patient care.
15) Behera:
'Behera' is another author of the study, signifying his contributions to the research. The inclusion of his name denotes collaboration and expertise within the research team, which is essential for developing reliable methodologies and ensuring the validity of results in pharmaceutical analysis.
16) Powder:
'Powder' refers to the solid form of Anastrozole utilized in tablet formulations. Understanding the properties of the powdered drug aids in the preparation and dissolution processes within the spectrophotometric method, ensuring accurate estimation of concentration in various pharmaceutical applications.
17) Rules:
'Rules' denote the established guidelines, specifically the International Conference on Harmonization (ICH) regulations adhered to during method validation. Compliance with these rules ensures that the proposed method meets international standards for accuracy, precision, and reliability, crucial for regulatory acceptance and public trust.
18) Sahu:
'Sahu' identifies another contributing author of the study. This inclusion highlights the collaborative nature of the research team, where shared expertise and diverse perspectives are crucial for the comprehensive exploration and successful execution of the methodologies applied in the study.