Harmonization of EU and US methods for glimepiride by HPLC
Journal name: World Journal of Pharmaceutical Research
Original article title: Harmonization of european pharmacopeial and us pharmacopeial methods of glimepiride by hplc
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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Dr. Amit Gosar and Sagar Gaikwad
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: Harmonization of european pharmacopeial and us pharmacopeial methods of glimepiride by hplc
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
Doi: 10.20959/wjpr20173-7937
Download the PDF file of the original publication
Summary of article contents:
Introduction
Glimepiride is a sulphonylurea medication used primarily for the management of type 2 diabetes by stimulating insulin release from pancreatic β-cells. It is recognized as an official compound in both the European Pharmacopoeia (EP) and the United States Pharmacopoeia (USP). This research paper, conducted by Dr. Amit Gosar and Sagar Gaikwad, details the harmonization of analytical methods for Glimepiride using High-Performance Liquid Chromatography (HPLC). The main objectives were to streamline the analysis between EP and USP specifications, thus enhancing efficiency and reducing costs.
Harmonization of Analytical Methods
One of the significant outcomes of this research is the development of harmonized analytical methods for Glimepiride. The study successfully integrated the Assay, Related Substances analysis, and chiral impurity assessments from both EP and USP. Prior to harmonization, separate methods required distinct analytical setups, which increased operational time and resource allocation. The harmonization not only facilitates a single robust testing process for Glimepiride but has also been validated according to the International Conference on Harmonization (ICH) guidelines, ensuring reliability and standardization.
Validation Procedures and Results
The validation of the harmonized methods covered several key parameters such as specificity, limit of detection (LOD), limit of quantitation (LOQ), linearity, accuracy, and precision. These parameters confirmed that the harmonized methods effectively meet the necessary analytical requirements and produce consistent results across both EP and USP methods. The methods were shown to have high specificity, with no interference from impurities, and demonstrated robust performance in terms of LOD and LOQ, ensuring accurate quantification of Glimepiride and its impurities.
Cost and Time Efficiency
The study highlights a substantial reduction in time and costs attributed to the harmonization of methods. By consolidating the analysis process, the time required for testing Glimepiride can be reduced by up to 50%, along with halving the number of required HPLC instruments and chemists. The financial benefits are significant, with potential savings of ₹26,000 per batch when utilizing the harmonized method compared to separate analyses according to EP and USP. This economic advantage makes the harmonized method a favorable choice for pharmaceutical manufacturers.
Conclusion
In conclusion, the harmonization of HPLC methods for Glimepiride presents an efficient approach to analytical testing in pharmaceuticals. By aligning the EP and USP specifications, the research not only streamlines the analytical process but also substantiates the accuracy and reliability of the results obtained. The substantial cost and time savings further enhance the practicality of implementing these harmonized methods in routine laboratory settings, providing a compelling case for their adoption in the pharmaceutical industry. The authors express gratitude towards Indoco Remedies Ltd. for their support in this research, indicating the collaborative efforts essential for advancing pharmaceutical analysis.
FAQ section (important questions/answers):
What is the main purpose of harmonizing Glimepiride analysis methods?
The main purpose is to create a common analysis method for Glimepiride that meets both EP and USP standards, saving up to 50% in time and costs.
What are the key parameters analyzed for Glimepiride?
Key parameters include assay, related substances, and analysis of impurities, which are crucial for regulatory compliance and product quality.
What type of chromatography is used for Glimepiride analysis?
High-performance liquid chromatography (HPLC) is employed for analyzing Glimepiride and its related substances.
What is the result of harmonizing methods with respect to analysis cost?
Harmonization reduces the analysis cost per batch of Glimepiride from 54,000 to 28,000, leading to significant savings.
Which reagents were used in the Glimepiride analysis?
Reagents included sodium dihydrogen phosphate, acetonitrile, ortho-phosphoric acid, and several solvents for mobile phase preparation.
How was method validation conducted for the Glimepiride analysis?
Validation followed ICH guidelines, focusing on parameters like specificity, accuracy, precision, and limits of detection and quantitation.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “Harmonization of EU and US methods for glimepiride by HPLC”. 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) Substance:
The term 'Substance' refers to a specific chemical compound or formulation being studied or analyzed. In this context, Glimepiride is the focal substance, which is crucial for the analysis of its related impurities. Understanding the characteristics and behavior of the substance is essential for effective quality control and assurance in pharmaceutical research.
2) Study (Studying):
The word 'Study' indicates the systematic investigation undertaken to explore the harmonization of pharmacopoeial methods for Glimepiride analysis. It involves the application of scientific methods to validate the efficacy, reliability, and cost-saving benefits of using a standardized procedure, which is essential for regulatory compliance and enhanced analytical efficiency.
3) Performance:
In this context, 'Performance' relates to the effectiveness of the harmonized High Performance Liquid Chromatography (HPLC) methods in analyzing Glimepiride and its impurities. It encompasses how accurately, precisely, and quickly the methods meet the specified parameters and objectives set by both EP and USP guidelines.
4) Water:
The word 'Water' is significant as it is often used as a solvent in the preparation of mobile phases for HPLC analysis. In the study, a mixture of water and acetonitrile is employed to create the solvent environment necessary for the separation and quantification of Glimepiride and its related substances.
5) India:
The mention of 'India' highlights the geographical context of the research, specifically pointing to the Indoco Research Center where the study was conducted. It underscores the country's growing role in pharmaceutical research and development, particularly in harmonizing international standards of drug analysis and quality control.
6) Relative:
'Relative' in this paper pertains to the analysis of substances that are structurally or chemically associated with the main compound, Glimepiride. The study emphasizes the importance of identifying and quantifying these related substances to ensure the safety, efficacy, and quality of the pharmaceutical product being tested.
7) Sagar (Sagár):
'Sagar' refers to one of the authors of the research study, indicating his contribution to the harmonization of the analytical methods. His role signifies collaboration in scientific research, where multiple experts work together to achieve common objectives in improving the quality and efficiency of pharmaceutical analysis.
8) Table:
'Table' pertains to the structured presentation of data, specifically results from the study. Tables are crucial in scientific documentation as they provide a clear, concise summary of experimental parameters, outcomes, and findings, making it easier for readers to comprehend complex data at a glance.
9) House:
'House' in this context usually refers to 'in-house,' indicating that the harmonization of methods was performed within the organization conducting the research. This signifies the capacity of the organization to develop and validate methods without external reliance, fostering innovation and self-sufficiency in pharmaceutical practices.
10) Calculation:
'Calculation' denotes the analytical computation involved in determining the costs, concentrations, or efficiencies presented in the study. It emphasizes the quantitative aspect of the research, allowing for budget assessments and financial projections regarding the savings achieved by implementing harmonized methods in drug analysis.
11) Discussion:
'Discussion' encompasses the section where results are interpreted and contextualized. It involves critical analysis and synthesis of findings, connecting them to existing literature, implications for practice, and future research directions. It is vital for deriving insights and drawing conclusions based on the empirical data obtained.
12) Purity:
'Purity' signifies the measure of how free a substance is from contaminants or impurities. In pharmaceutical analysis, particularly for Glimepiride, ensuring high purity is crucial for regulatory compliance, safety considerations, and therapeutic effectiveness, directly influencing the quality of the final product being manufactured.
13) Rupee:
'Rupee' serves as the currency reference in the cost analysis of the harmonized method for Glimepiride. It highlights the economic aspect of pharmaceutical testing, demonstrating how harmonization can lead to significant cost savings, thus impacting financial decision-making and resource allocation within the organization.