Stability indicating hplc determination of quetiapine fumarate
Journal name: World Journal of Pharmaceutical Research
Original article title: Stability indicating hplc determination of quetiapine fumarate
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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Zarna Ronak Dedania, Ronak Ratilal Dedania and Navin R. Sheth
World Journal of Pharmaceutical Research:
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Full text available for: Stability indicating hplc determination of quetiapine fumarate
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
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Summary of article contents:
Introduction
Quetiapine fumarate is an atypical antipsychotic medication employed in the treatment of schizophrenia and acute manic episodes associated with bipolar I disorder. The research aimed to establish a validated stability-indicating assay method (SIAM) for quetiapine fumarate by exposing it to various stress conditions, including hydrolysis, oxidation, photolysis, and thermal stress. High-Performance Liquid Chromatography (HPLC) was utilized for the separation of the compound, and the method showed excellent validation results, confirming its effectiveness in determining the stability and concentration of quetiapine fumarate in pharmaceutical formulations.
Method Development and Validation
The HPLC method was developed using a C18 column with a mobile phase composed of methanol, acetonitrile, and water in the ratio of 67:16:17, at a flow rate of 1 ml/min, with a detection wavelength of 220 nm. The linearity of the method was confirmed over a concentration range of 10-50 μg/ml with a correlation coefficient (r²) of 0.998, demonstrating the method's reliability. Additionally, the limit of detection (LOD) and limit of quantitation (LOQ) were established as 3.27 μg/ml and 9.92 μg/ml, respectively. The method also showcased high precision and accuracy, with recovery rates between 99.68% to 100.37%.
Stability Studies
Forced degradation studies were conducted using various stress conditions to assess the stability-indicating capabilities of the HPLC method. The results indicated that quetiapine fumarate exhibited significant degradation under oxidative conditions, with a 61.45% loss observed when exposed to hydrogen peroxide. Under acidic and alkaline conditions, approximately 24.56% and 25.42% degradation were noted, respectively. Thermal degradation studies revealed a modest stability at elevated temperatures, with only 8.42% degradation after 36 hours at 80°C, and photolytic conditions resulted in a 5.45% decrease in the drug content.
Specificity and Robustness
The method demonstrated high specificity, effectively differentiating quetiapine fumarate from its degradation products and any potential excipients present in tablet formulations. Validation of robustness showed that minor modifications to chromatographic conditions did not significantly affect method performance. System suitability tests further confirmed the method's reliability, with good chromatographic conditions reflected in peak resolution, tailing factor, and theoretical plates.
Conclusion
The study successfully established a validated SIAM for quetiapine fumarate using HPLC, capable of separating the drug from its degradation products and ensuring accurate quantification in pharmaceutical formulations. This method not only facilitates routine analysis of quetiapine fumarate in bulk and tablet forms but also provides insight into the drug's stability under various stress conditions. The findings warrant further exploration into the degradation kinetics of quetiapine fumarate and its determination in biological matrices, reinforcing the method's potential application in the pharmaceutical industry.
FAQ section (important questions/answers):
What is the main objective of the study on Quetiapine fumarate?
The study aimed to develop a validated stability-indicating assay method for Quetiapine fumarate after subjecting it to various forced degradation conditions like hydrolysis, oxidation, photolysis, and thermal stress.
Which analytical technique was used for the analysis of Quetiapine?
The research utilized High Performance Liquid Chromatography (HPLC) for the analysis, employing a C18 column and specific mobile phase conditions to separate and assess the compound effectively.
How was the stability of Quetiapine fumarate assessed?
Stability was assessed through forced degradation studies, including acid, alkali, oxidation, thermal stress, and photostability, with HPLC used to analyze the degradation products and recovery rates.
What were the results regarding the linearity of the HPLC method?
The method exhibited linearity in the concentration range of 10-50 μg/ml with a correlation coefficient of 0.998, confirming its reliability in quantifying Quetiapine fumarate.
What was the recovery rate of Quetiapine in tablet analysis?
The recovery of Quetiapine fumarate from tablet formulations ranged from 99.68 ± 1.67% to 100.37 ± 1.34%, indicating high accuracy and precision of the method.
What conclusions were drawn from the study's HPLC method?
The developed HPLC method for Quetiapine fumarate is validated, selective, and stability-indicating, suitable for routine analysis in pharmaceutical formulations, with applications in detecting related impurities and degradation kinetics.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “Stability indicating hplc determination of quetiapine fumarate”. 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 keyword 'Drug' in this context refers to Quetiapine fumarate, an atypical antipsychotic medication used primarily in treating schizophrenia and bipolar disorder. The study focuses on the stability and analytical methods relevant to this drug, highlighting its importance for ensuring safety and efficacy in pharmaceutical applications.
2) Table:
In the manuscript, 'Table' is used to present data regarding the assay method's precision, accuracy, and recovery rates. Tables are essential in scientific literature for summarizing results in an organized manner, making it easier for readers to interpret quantitative data and compare different experimental outcomes.
3) Powder:
The term 'Powder' relates to the form of Quetiapine fumarate used in the experiments. Powders are common formulations for pharmaceutical compounds, and their physical characteristics can influence stability, solubility, and bioavailability, all critical factors in drug formulation and testing.
4) Water:
'Water' is a component of the mobile phase used in High-Performance Liquid Chromatography (HPLC). Given its importance as a solvent, it helps in the dissolution and separation of Quetiapine fumarate during analysis. The purity and composition of water directly affect the reliability of analytical results.
5) Purity:
'Purity' is a crucial concept in pharmaceutical analysis, referring to the absence of impurities in a drug substance. The study emphasizes the importance of establishing the purity of Quetiapine fumarate through stability-indicating methods, ensuring the safety and effectiveness of the drug in medical use.
6) India:
The keyword 'India' highlights the geographical context of the study, with the research conducted in institutions located in India. This is significant as it may influence the availability, production, and quality control processes of Quetiapine fumarate within the Indian pharmaceutical market.
7) Study (Studying):
'Study' refers to the systematic investigation conducted to develop and validate the HPLC method for analyzing Quetiapine fumarate. It encompasses all experimental conditions, methodologies, and findings aimed at ensuring the reliability and effectiveness of the proposed analytical techniques.
8) Activity:
'Activity' in this context is related to the pharmacological effects of Quetiapine fumarate as an antipsychotic. Understanding the activity involves exploring how the drug interacts with receptors in the brain to exert its therapeutic effects, critical for evaluating its clinical efficacy.
9) Saurashtra (Saurastra):
'Saurashtra' refers to a region in Gujarat, India, where one of the research institutions involved in the study is located. The regional context may affect local pharmaceutical regulations, the development of drugs, and partnerships with local industry, impacting overall research outcomes.
10) Tripada (Tri-pada):
'Tripada' is relevant as it is the name of the pharmaceutical company that provided the Quetiapine fumarate standard used in the study. Partnerships with companies are vital for ensuring access to high-quality materials necessary for pharmaceutical research and development.
11) Surata (Surat, Su-rata, Shurata):
'Surat' is the city where Bhagwan Mahavir College of Pharmacy is situated, indicating the local educational and research environment. The location often plays a role in the infrastructure available for pharmaceutical research, including equipment and academic resources.
12) Noise:
'Noise' in this context refers to background signals in HPLC analysis that can interfere with the detection of the drug. Measurement precision demands minimizing noise to enhance the accuracy of quantitation, crucial for reliable analytical methodology in pharmaceutical research.
13) Performance:
'Performance' relates to the efficacy of the proposed HPLC method, measuring its ability to achieve consistent and reliable results under specified conditions. Good performance ensures that the methodology can be used effectively for routine quality control of pharmaceutical products.
14) Discussion:
'Discussion' is a critical part of the manuscript where authors interpret results, compare findings with existing literature, and explain the implications of their work. It provides context for the significance of the study, offering insights into the robustness and applicability of the new method.
15) Drowsiness:
'Drowsiness' is an adverse effect associated with the use of Quetiapine fumarate, highlighting the importance of monitoring side effects as part of pharmacological activity. Understanding such side effects is key for patient safety and guiding healthcare providers in prescribing practices.
16) Resolving:
'Resolving' refers to the separation of Quetiapine fumarate from other components during HPLC analysis. Effective resolving power is essential for accurately quantifying the drug in the presence of impurities or degradation products, ensuring reliable analytical results.
17) Gujarat:
'Gujarat' is the state in India where this research was conducted. The state's pharmaceutical industry landscape and regulatory environment can influence drug production quality and innovation, making it a significant context for the research findings and their implications.
18) Science (Scientific):
'Science' encompasses the systematic study of the natural world through observation and experimentation. This research exemplifies the application of scientific methods to pharmaceutical analytics, contributing to the body of knowledge that ensures drug safety and efficacy in healthcare.
19) Reason:
'Reason' may refer to the rationale behind choosing specific methods and techniques in the study. Articulating reasons for experimental design choices is crucial for justifying the research approach and outcomes, facilitating understanding and replication in future studies.
Other Science Concepts:
Discover the significance of concepts within the article: ‘Stability indicating hplc determination of quetiapine fumarate’. Further sources in the context of Science might help you critically compare this page with similair documents:
Analytical method, High performance liquid chromatography, Quantitative analysis, Analytical grade, Retention time, Sample analysis, Pharmaceutical analysis, Recovery study, Graphical representation, Tablet formulation, Limit of detection, Solid-phase extraction, Calibration curve, Stability Studies, Specificity, Chemical reagents, Method validation, Limit of quantitation, Precision study, Standard solution, Oxidation, Biological fluid.