RP-HPLC method for desvenlafaxine succinate in tablets.
Journal name: World Journal of Pharmaceutical Research
Original article title: Rp-hplc method development and validation of desvenlafaxine succinate monohydrate in 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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Ratna Kailas Pingle, Kishor Salunkhe, Sanjay Chaudhari
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: Rp-hplc method development and validation of desvenlafaxine succinate monohydrate in tablet dosage form
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
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Summary of article contents:
Introduction
Desvenlafaxine succinate is a novel antidepressant drug utilized for treating major depressive disorder (MDD) as a serotonin-norepinephrine reuptake inhibitor (SNRI). Despite its clinical significance, Desvenlafaxine succinate is not officially listed in any pharmacopoeia. The aim of this study was to develop and validate a rapid, accurate, and simple reversed-phase high-performance liquid chromatography (RP-HPLC) method for quantifying Desvenlafaxine succinate in tablet formulations.
Method Development and Validation
The RP-HPLC method was developed using a Kromasil C-18 column, with acetonitrile and ammonium phosphate buffer at pH 3.0 as the mobile phase, optimized for a flow rate of 1 mL/min. The method demonstrated high sensitivity with UV detection at 220 nm and showed a linear response over a concentration range of 20-160 μg/mL. Mean retention time for Desvenlafaxine succinate was recorded at approximately 2.44 minutes, and the assay of the tablet formulations resulted in a percentage label claim close to 100%.
Methods of Analysis
The study included thorough method validation according to ICH guidelines, assessing parameters such as specificity, linearity, accuracy, precision, and robustness. Specificity testing confirmed no interference from excipients. The linearity results exhibited a correlation coefficient of 0.999, indicating excellent linearity. Accuracy was verified through recovery studies, showing mean percentage recoveries around 99.67%. Precision results were all below the acceptable limit (2% RSD), and robustness tests indicated that small variations in method conditions had negligible effect on the chromatographic results.
Significance of the Findings
The development of the RP-HPLC method provides a validated analytical approach that fulfills the requirements for routine quality control of Desvenlafaxine succinate in commercial tablet forms. This method not only supports pharmaceutical quality assurance but also enhances the efficiency of regulatory compliance related to medication formulation.
Conclusion
The successful development and validation of the RP-HPLC method for determining Desvenlafaxine succinate demonstrate its reliability for routine analysis in pharmaceutical laboratories. The method's simplicity, accuracy, precision, and robustness position it as an effective tool for quality control of medications containing this important antidepressant. This advancement contributes to ensuring the safety and efficacy of pharmaceutical products in the market.
FAQ section (important questions/answers):
What was the purpose of the RP-HPLC method developed?
The RP-HPLC method aimed to accurately determine Desvenlafaxine succinate in tablet dosage forms, ensuring rapid and simple analysis.
What are the key components of the mobile phase used?
The mobile phase consisted of Acetonitrile and Dibasic ammonium phosphate buffer, mixed in a ratio of 70:30 v/v.
At what wavelength was UV detection performed during analysis?
UV detection for the quantification of Desvenlafaxine succinate was carried out at a wavelength of 220 nm.
How was the method validated according to ICH guidelines?
The method was validated based on specificity, linearity, accuracy, precision, and robustness, demonstrating reliable analytical performance.
What was the average assay percentage found for Desvenlafaxine?
The average assay percentage for Desvenlafaxine succinate in tablet formulations was computed as 99.77%, indicating high accuracy.
What institutions provided support during the research study?
Religare Pharma, Nasik provided the Desvenlafaxine sample, while Amrutvahini College of Pharmacy supported the necessary research facilities.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “RP-HPLC method for desvenlafaxine succinate in 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) Table:
In the context of scientific research, 'Table' refers to a structured arrangement of data, often summarizing results or characteristics of studies conducted. It presents statistical information concisely, aiding readers in interpreting findings more effectively. In the provided document, tables summarize chromatographic conditions, assay results, and validation parameters.
2) Drug:
The term 'Drug' refers to a substance used for medical purposes, including treatment, diagnosis, or prevention of diseases. In this study, Desvenlafaxine Succinate is the primary drug investigated, which is used as an antidepressant. Understanding its chemical properties and how to quantify it accurately is crucial for therapeutic effectiveness.
3) Quality:
'Quality' in pharmaceutical research pertains to the standards and characteristics that a drug must meet to ensure safety and efficacy. This study emphasizes the importance of quality control methods in ensuring that medications like Desvenlafaxine Succinate adhere to regulatory standards for patient safety and treatment effectiveness.
4) Powder:
In pharmaceutical formulations, 'Powder' refers to a finely ground substance used for making tablets or capsules. The process of crushing tablets into powder for analysis is essential in this study, as it allows for accurate measurement and quantification of the active drug substance before chromatographic examination.
5) Study (Studying):
'Study' signifies an organized investigation aimed at understanding a particular phenomenon or testing a hypothesis. This document details a study focused on developing and validating a chromatographic method to quantify Desvenlafaxine Succinate in tablet form, demonstrating systematic and rigorous research methodology.
6) Performance:
'Performance' in this context relates to how well a developed analytical method functions, including its accuracy, precision, and reproducibility. The performance of the RP-HPLC method is crucial for ensuring reliable results in quantifying Desvenlafaxine Succinate, impacting its application in quality control.
7) Discussion:
'Discussion' is a critical section in scientific papers where results are interpreted, and their implications are explored. In this study, the discussion reflects on the findings from the HPLC method validation, emphasizing the method’s reliability and its potential impact on pharmaceutical quality control.
8) Relative:
'Relative' typically describes the relationship or comparison between two or more entities. In this research, it may pertain to metrics such as the relative standard deviation (%RSD) that assess the consistency and reliability of the analytical results obtained from the developed method.
9) Ratna (Ratnā):
'Ratna' is part of the name of one of the authors associated with this research. Author names in academic papers are significant as they provide credit for the work and establish the contributions of individual researchers to the study, which is crucial for scientific acknowledgment.
10) Kaila (Kāīla, Kailā):
'Kaila' is another component of the author's name featured in this study. Researchers’ names represent their contributions to the body of knowledge in their field. The association of names with specific studies is important for academic integrity and gives insight into the expertise behind the research.
11) Nasik (Nāsik):
'Nasik' is the location of Religare Pharma, the company that provided the sample used in the research. The geographical context can influence research due to the proximity to pharmaceutical manufacturers and resources, which can impact the availability and quality of materials for studies.
12) Water:
'Water' is often used as a solvent in pharmaceutical research. In this study, it is crucial for preparing buffer solutions and diluents in HPLC, highlighting its importance in chromatography. The purity and quality of water directly affect the accuracy of analytical results.
13) Line:
'Line' indicates a linear relationship, often pertinent in discussing calibration curves or the linearity of a method. In this study, establishing a linear correlation between concentration and response is critical for quantifying Desvenlafaxine Succinate accurately, influencing measurements across the concentration range.
14) Observation:
'Observation' refers to the process of noting or recording findings during an experiment. In this research, careful observation of chromatographic results is vital for assessing method performance, identifying any deviations, and ensuring the validity of the data collected during the HPLC analysis.
15) Medicine:
'Medicine' refers to the field encompassing pharmaceuticals, therapeutics, and medical treatments. This study is situated within the broader discipline of medicine, as it aims at enhancing the understanding and accurate quantification of drugs like Desvenlafaxine Succinate for therapeutic applications.
16) Company:
'Company' refers to a business entity such as Religare Pharma that engages in pharmaceutical development and production. Companies play a significant role in research by providing samples, funding, and expertise, and their collaboration is crucial for advancing pharmaceutical science and research.
17) Anxiety:
'Anxiety' is a mental health condition that Desvenlafaxine is used to treat in addition to major depressive disorder (MDD). Understanding the therapeutic applications of the studied drug emphasizes its significance in healthcare and the importance of reliable methods for analyzing its formulation.
18) Pur (Pūr):
'Poor' typically refers to a suboptimal condition or state. In this study, it may relate to various analyses that can lead to poor resolution or performance in methods of separating compounds or obtaining clear results, which the research aims to improve through method validation.