"Method development and validation of brexpiprazole by spectroscopy and chromatography."

| Posted in: Science

Journal name: World Journal of Pharmaceutical Research
Original article title: Method development and validation of brexpiprazole by using spectroscopic and chromatographic method
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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Author:

Sanuli V. Poulkar, Sangram U. Deshmukh, Dhanraj N. Wasmate and Shyamalila B. Bavage


World Journal of Pharmaceutical Research:

(An ISO 9001:2015 Certified International Journal)

Full text available for: Method development and validation of brexpiprazole by using spectroscopic and chromatographic method

Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research

Doi: 10.20959/wjpr20233-26872


Download the PDF file of the original publication


Summary of article contents:

Introduction

Brexpiprazole is a significant antipsychotic medication used mainly in the treatment of schizophrenia and as an adjunct for major depressive disorder (MDD) in adults. It functions by modulating the actions of neurotransmitters in the brain, particularly dopamine and serotonin. This drug operates as a serotonin-dopamine activity modulator (SDAM), displaying partial agonism at specific receptors and antagonism at others, which contributes to its therapeutic efficacy. The present study focuses on the method development and validation of brexpiprazole using both spectroscopic and chromatographic techniques, adhering to ICH guidelines.

Method Development and Validation

The study outlines the preparation of standard stock solutions of brexpiprazole, followed by spectrophotometric analysis. The peak absorbance wavelength was determined to be 218 nm, which facilitated its analysis. The method demonstrated linearity over a concentration range from 4 µg/ml to 6 µg/ml with a high correlation coefficient of 0.999. Stability, limit of detection (LOD), and limit of quantification (LOQ) parameters were established, ensuring the method’s reliability and sensitivity for quality control purposes.

Chromatographic Analysis

Chromatographic trials were conducted to optimize the method for brexpiprazole using high-performance liquid chromatography (HPLC). Different mobile phase compositions, including Formic Acid and Acetonitrile in varying ratios, were tested. Peak parameters, such as retention time, asymmetry, and peak purity, were evaluated, yielding promising results with a correlation coefficient of 0.999. Notably, a peak purity analysis indicated consistent separation and specificity for brexpiprazole, underscoring the effectiveness of the validated method.

Accuracy and Precision

The accuracy of the spectrophotometric and chromatographic methods was assessed through recovery experiments across various concentration levels. Brexpiprazole displayed recovery rates around 99-100%, confirming the method's accuracy. Precision tests, both interday and intraday, demonstrated low variability, with relative standard deviations (RSD) below acceptable thresholds. Such precision reinforces the reliability of the analytical methods developed for routine quality assessments in pharmaceutical applications.

Conclusion

In summary, the developed and validated UV spectrophotometric and HPLC methods for brexpiprazole are effective for routine analysis and quality control. The processes are not only simple and rapid but also exhibit high accuracy and precision. The study highlights the relevance of robust analytical methods in ensuring the consistent quality of pharmaceutical products while adhering to environmental and economic considerations. These findings pave the way for further research and application in pharmaceutical sciences, ensuring the safe and effective use of brexpiprazole in clinical settings.

FAQ section (important questions/answers):

What is brexpiprazole and its primary use?

Brexpiprazole is an antipsychotic medication used primarily to treat schizophrenia and is also employed alongside other medications to address major depressive disorder in adults.

How was the brexpiprazole analysis conducted in this study?

The analysis used both spectroscopic and chromatographic methods, including a UV spectrophotometric determination at 218 nm and HPLC with appropriate method development and validation as per ICH guidelines.

What are the main properties of brexpiprazole?

Brexpiprazole is a white-to-off-white, non-hygroscopic crystalline powder with a melting point of 178-181°C and is practically insoluble in water.

What were the accuracy results of the UV method for brexpiprazole?

The UV method demonstrated high accuracy with recovery percentages around 100%, indicating its reliability for quantifying brexpiprazole in bulk drug formulations.

What instruments were used for the method development?

The method development utilized instruments such as HPLC Agilent 1260 Infinity II, UV Labman 1900 for spectrophotometry, and various analytical balances and sonicators.

What does the study conclude about the proposed UV method?

The study concludes that the UV spectrophotometric method is simple, accurate, precise, and environmentally friendly, providing consistent, reliable data and saving time and costs.

Glossary definitions and references:

Scientific and Ayurvedic Glossary list for “"Method development and validation of brexpiprazole by spectroscopy and chromatography."”. 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 research, a table organizes and presents data clearly and concisely, allowing readers to quickly grasp complex information. Tables facilitate comparisons and highlight key findings, making them invaluable for analysis in scientific papers, such as the presented study on brexpiprazole. They structure experimental results systematically.

2) Purity:
Purity refers to the absence of impurities in a substance, particularly in pharmaceuticals where ensuring the effectiveness and safety of drugs is critical. The purity of brexpiprazole, as analyzed in this research, is vital for confirming the drug's identity and quality, ultimately influencing therapeutic outcomes for patients.

3) Water:
Water, often used as a solvent in chemical processes, plays a crucial role in pharmaceutical formulations and analyses. In this study, water is mentioned as part of diluent preparation and mobile phase formulations, underlining its significance in achieving desired concentrations and facilitating proper drug analysis methods.

4) Drug:
A drug is any substance used for medical treatment, prevention, or diagnosis of diseases. Brexpiprazole, referenced extensively in the text, is an antipsychotic drug developed to target specific receptors in the brain. Understanding its properties and methods of analysis is essential for ensuring safe and effective therapy in clinical settings.

5) Maharashtra (Maharastra, Maha-rashtra):
Maharastra is a state in India where the research for the development and validation of brexpiprazole was conducted. The geographical context establishes the origin of the study, indicating local pharmaceutical education and research developments in the region that contribute to advancements in drug formulations and healthcare initiatives.

6) Powder:
Powder is a common physical form of pharmaceutical substances, including brexpiprazole. The text specifies that brexpiprazole appears as a white to off-white powder, highlighting its physical characteristics. The powder form is relevant for stability, solubility, and ease of handling in laboratory analyses and pharmaceutical formulations.

7) India:
India is recognized for its pharmaceutical research and development, housing numerous educational and research institutions. The study conducted at a pharmacy college in India showcases the country's commitment to advancing pharmaceutical sciences and improving medication quality, which impacts health outcomes locally and globally through responsible drug manufacturing.

8) Observation:
Observation, an act of closely monitoring and noting data during research, is essential for scientific inquiry. Each observation contributes to understanding the behavior of brexpiprazole under different conditions, allowing researchers to refine methods and ensure robust conclusions regarding its efficacy, safety, and quality in pharmaceutical applications.

9) Activity:
Activity in a pharmacological context refers to the effectiveness of a drug in its intended therapeutic action. The activity of brexpiprazole as a serotonin-dopamine activity modulator is central to its effectiveness in treating schizophrenia and depression, influencing its clinical use and the importance of evaluating its dosage and effects.

10) Quality:
Quality in pharmaceuticals relates to the consistency, purity, and integrity of drug formulations. The study emphasizes the importance of quality by detailing method validation processes that ensure brexpiprazole meets regulatory standards, as part of responsible pharmaceutical practice aimed at providing safe and effective medication to patients.

11) Money:
Money is a fundamental aspect of research funding and resource allocation in scientific studies. It affects the availability of materials, equipment, and manpower needed for method development and validation. Understanding financial considerations is essential for conducting robust research, especially in fields like pharmaceuticals where cost-effective methods can enhance accessibility.

Other Science Concepts:

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Discover the significance of concepts within the article: ‘"Method development and validation of brexpiprazole by spectroscopy and chromatography."’. Further sources in the context of Science might help you critically compare this page with similair documents:

High performance liquid chromatography, Chemical analysis, Molecular weight, Major depressive disorder, Mobile phase, Limit of detection, Limit of quantification, Method development, Intraday precision, Interday precision, Pharmaceutical Chemistry, HPLC, Analytical Procedure, Specificity, Method validation, Spectrophotometric determination, Chromatographic condition, Statistical parameter, Chromatographic method, Standard preparation, Dopamine D2 receptor.

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