LC-MS/MS method for azelnidipine: development, validation, degradation.
Journal name: World Journal of Pharmaceutical Research
Original article title: Analytical method development, validation and force degradation study for estimation of azelnidipine using liquid chromatography-tandem mass spectrometry
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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Unnati Naik, Komal Sutaria and Bhavdip Hirapara
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: Analytical method development, validation and force degradation study for estimation of azelnidipine using liquid chromatography-tandem mass spectrometry
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
Doi: 10.20959/wjpr202210-24948
Copyright (license): WJPR: All rights reserved
Download the PDF file of the original publication
Summary of article contents:
Introduction
Azelnidipine is a long-acting dihydropyridine calcium channel blocker primarily used for treating high blood pressure and angina pectoris. This study aimed to develop and validate a novel liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for quantifying Azelnidipine and identifying its degradation products under various stress conditions. The research followed established International Conference on Harmonization (ICH) guidelines for analytical methods, emphasizing a need for reliable methods as few analytical techniques for Azelnidipine have been documented in existing literature.
Method Development and Validation
The developed LC-MS/MS method was characterized by a simple and rapid process utilizing a 20:80 mixture of 10mM ammonium formate buffer in water (pH 4.0) and acetonitrile as the mobile phase. The analysis was performed on an Agilent Zorbax C18 column at a flow rate of 1 mL/min with a run time of 10 minutes. Validation parameters, including linearity, limit of detection (LOD), limit of quantification (LOQ), accuracy, precision, and robustness, were extensively evaluated. Results indicated that the method achieved satisfactory sensitivity and reliability, with LOD and LOQ determined to be 0.173 µg/mL and 0.526 µg/mL, respectively, demonstrating the method's applicability for routine analysis of Azelnidipine.
Stability Study Under Stress Conditions
The study examined Azelnidipine's stability through force degradation studies under different stress conditions (acidic, basic, oxidative, thermal, and photolytic). The results indicated that Azelnidipine was unstable under acidic, basic, and oxidative conditions, while remaining stable under thermal and photolytic conditions. Chromatographic analyses demonstrated significant degradation in acidic and alkaline environments, whereas no notable degradation was observed under thermal or photo conditions. These findings are critical for understanding the drug's chemical behavior and for ensuring its integrity in pharmaceutical formulations.
Fragmentation Pathway Analysis
Through LC and LC-MS assessments, the fragmentation pathways of Azelnidipine and its degradation products were analyzed. The mass spectral data revealed the molecular ion peaks and their corresponding fragment profiles for Azelnidipine and its degradation products, furthering the understanding of its chemical stability. Identifying these pathways is essential for both the characterization of the compound and the development of effective stability-indicating methods. Particular attention was given to the stability of various degradation products, aiding in the identification of the compounds with potential therapeutic implications.
Conclusion
In conclusion, this research establishes a reliable LC-MS/MS method for quantifying Azelnidipine and understanding its degradation profile under various stress conditions. The method demonstrates significant sensitivity and precision, suitable for routine pharmaceutical analysis. The stability study revealed vital insights into how Azelnidipine behaves chemically in different environments, contributing to better management in therapeutic contexts. Overall, the method's simplicity, sensitivity, and robustness emphasize its potential use in further studies and practical applications within the pharmaceutical industry.
FAQ section (important questions/answers):
What is the study about Azelnidipine focused on?
The study developed and validated an LC-MS/MS method to analyze Azelnidipine's stability and identify degradation products under various stress conditions such as acidic, basic, and oxidative environments.
What are the key findings regarding Azelnidipine's stability?
Azelnidipine was found to degrade in acidic, basic, and oxidation conditions, but it remained stable under thermal and photo degradation conditions.
What method was used to analyze Azelnidipine in this study?
A novel liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was developed and validated for sensitivity and stability indication.
Which validation parameters were evaluated in the study?
Validation parameters such as linearity, accuracy, precision, limit of detection (LOD), limit of quantification (LOQ), and robustness were assessed according to ICH guidelines.
How does the proposed method compare to previous methods?
The proposed method provides greater sensitivity and selectivity for determining degradation products compared to previously reported methods, all achieved within a short run time.
Who contributed to the research presented in this study?
The research was conducted by Unnati Naik, Komal Sutaria, and Bhavdip Hirapara, affiliated with K K Shah Jarodwala Maninagar Science College, Gujarat.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “LC-MS/MS method for azelnidipine: development, validation, degradation.”. 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 key component in the preparation of solutions for analytical chemistry. It acts as a solvent for dissolving various substances, including Azelnidipine. In the context of the study, water combined with other solvents facilitates the liquid chromatography process necessary for analyzing drug stability and degradation.
2) Study (Studying):
The study refers to the systematic investigation conducted to develop a reliable and validated LC-MS/MS method for estimating Azelnidipine. It involves exploring the drug's degradation behavior under different conditions, ultimately contributing to the advancement of pharmaceutical quality and safety through proper analytical methods.
3) Table:
Tables are used in the research to present data succinctly and clearly, making it easier for readers to digest complex information. They summarize key metrics such as concentration levels, recovery percentages, and results from method validation, aiding transparency and facilitating comparisons across different experimental conditions.
4) Gujarat:
Gujarat is the region in India where the research was conducted. The authors affiliated with K K Shah Jarodwala Maninagar Science College in Ahmedabad, Gujarat, leverage local academic and laboratory resources to advance pharmaceutical research. The regional connection emphasizes the importance of educational institutions in scientific discoveries.
5) Powder:
Powder refers to the solid state of Azelnidipine used in the study. It undergoes dissolution during the preparation of solutions for liquid chromatography. Understanding the physical form of the drug is vital for accurate dosing, analysis, and ensuring the efficacy of formulations in pharmaceutical applications.
6) Drug:
Drugs in this study specifically refer to pharmaceutical compounds, including Azelnidipine, that are subjected to analysis. The research aims to develop methods for accurately measuring drug stability and purity, thereby ensuring that drugs administered to patients are effective and free from harmful degradation products.
7) Channel:
Channel is related to calcium channel blockers like Azelnidipine, which inhibit the flow of calcium ions through cell membranes, thereby affecting muscle contraction and blood pressure. The effective functioning of these drugs in medical applications depends on understanding their mechanism of action on ion channels.
8) Science (Scientific):
Scientific refers to the rigorous methodologies and principles underpinning the study. The use of LC-MS/MS technology to analyze Azelnidipine’s stability exemplifies scientific inquiry, where systematic experimentation leads to knowledge accumulation that is essential for effective drug development and regulatory compliance.
9) Sah:
Shah is a reference to the principal of K K Shah Jarodwala Maninagar Science College, who played a supportive role in the research. The mention highlights the importance of institutional leadership in fostering academic research and encouraging students and staff to engage in meaningful scientific endeavors.
10) Blood:
Blood is relevant in the context of Azelnidipine, as the drug's primary function is to lower blood pressure. Understanding its pharmacokinetics, including its effects on the cardiovascular system, is essential for evaluating its therapeutic efficacy and safety for patients with hypertension.
11) Discussion:
Discussion sections in research papers synthesize findings and analyze their implications. Here, it includes interpretations of how Azelnidipine behaves under various degradation conditions, emphasizing the impact of pH, heat, and light. This analysis helps contribute to the broader knowledge in pharmaceutical sciences.
12) Substance:
Substance here refers to Azelnidipine or any compound studied regarding its chemical properties and behavior during the analyses. Identifying and understanding substances is crucial in pharmaceutical sciences for determining their efficacy, potential degradation, and compatibility with various formulations and conditions.
13) Relative:
Relative in this context pertains to comparisons made between different data points or drug stability conditions. For instance, evaluating how Azelnidipine's degradation varies under acidic versus alkaline conditions provides insights necessary for formulating stable pharmaceutical products that perform consistently.
14) Pouring:
Pouring is part of the laboratory protocols for preparing solutions, crucial for obtaining accurate concentrations of Azelnidipine in the study. Proper pouring techniques ensure consistency in sample preparation, which is critical for obtaining reliable results in analytical methods.
15) Filling (Filled):
Filling refers to the process of adding solvent to volumetric flasks to achieve desired concentrations. This step is integral in the preparation of stock solutions for Azelnidipine, ensuring accurate dosing that is essential for valid experimental results and effective drug formulation.
16) Animal:
Animal refers to preclinical studies that may involve testing drugs like Azelnidipine for safety and efficacy before human trials. Understanding drug effects in animal models provides insight into potential outcomes and helps to predict human responses to medication, ensuring safety in clinical use.
17) Kesar:
Kesar may refer to an instrumental or lab equipment provider or a colleague associated with the research team. Indicating collaborators or sponsors highlights the importance of teamwork and support in scientific research, which often requires diverse expertise and resources to advance knowledge.
Other Science Concepts:
Discover the significance of concepts within the article: ‘LC-MS/MS method for azelnidipine: development, validation, degradation.’. Further sources in the context of Science might help you critically compare this page with similair documents:
Liquid chromatography mass spectrometry, Liquid chromatography-tandem mass spectrometry, Multiple reaction monitoring, Intraday precision, Interday precision, Method validation, Relative standard deviation.