RP-HPLC method for metformin and saxagliptin: validation and analysis.
Journal name: World Journal of Pharmaceutical Research
Original article title: Stability-indicating rp-hplc method and its validation for analysis of metformin hydrochloride & saxagliptin in bulk and pharmaceutical 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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Naidu Srinivasa Rao, Dr. K. Venkataramana, and P.Anitha
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: Stability-indicating rp-hplc method and its validation for analysis of metformin hydrochloride & saxagliptin in bulk and pharmaceutical dosage form
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
Copyright (license): WJPR: All rights reserved
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Summary of article contents:
Introduction
A reverse phase high performance liquid chromatography (RP-HPLC) method has been developed and validated for the analysis of Metformin hydrochloride and Saxagliptin in pharmaceutical dosage forms. Researchers Naidu Srinivasa Rao and colleagues from Acharya Nagarjuna University aimed to create a rapid, precise, and sensitive analytical method for these two drugs, which are commonly used in the treatment of type 2 diabetes. The methodology includes chromatographic separation using specialized equipment and various stress tests to evaluate the stability of the compounds.
Method Development and Validation
The RP-HPLC method employed an Inertsil C8 column with a specific mobile phase composed of pH 2.5 buffer and acetonitrile in a 70:30 v/v ratio. The flow rate was set at 1.0 mL/min with a detection wavelength of 229 nm. The retention times for Metformin and Saxagliptin were determined to be 2.8 and 5.2 minutes, respectively. The method demonstrated excellent linearity for both compounds, with correlation coefficients of 0.999 for Metformin and 0.999 for Saxagliptin over their respective concentration ranges. Validation was conducted in accordance with ICH guidelines, confirming the method’s accuracy, precision, and reproducibility.
Forced Degradation Studies
To assess the stability and robustness of the developed method, forced degradation studies were performed under various stress conditions, including thermal, photolytic, hydrolytic, acid, alkali, and oxidative stress. The results indicated that both Metformin and Saxagliptin maintained stability under the different conditions tested. For instance, Metformin showed varying degradation percentages under different stress tests, with the most significant degradation observed in acidic and alkali conditions. This comprehensive analysis showcased the method's capacity to detect degradation products effectively, thereby confirming its suitability for stability-indicating purposes.
Accuracy and Precision
The accuracy of the method was evaluated through recovery studies at various concentration levels (50%, 100%, and 150%), yielding recovery rates between 99% and 102% for both drugs. Additionally, the precision was assessed using intra-day and inter-day variations, with results indicating a relative standard deviation (RSD) of less than 2.0%, highlighting the method’s reliability. By testing multiple replicate injections and comparing results from different days, the researchers affirmed that the method produces consistent results across various conditions.
Conclusion
The validated RP-HPLC method developed for the simultaneous quantification of Metformin hydrochloride and Saxagliptin has demonstrated significant advantages, including specificity, sensitivity, and speed. It is effective for routine analysis and quality control of pharmaceutical preparations containing these drugs. The study provides a robust framework for future research and application in pharmaceutical analytics, ensuring accurate assessment of drug stability and content in combined formulations. The authors express gratitude towards Acharya Nagarjuna University for facilitating the research endeavors.
FAQ section (important questions/answers):
What is the purpose of the developed RP-HPLC method?
The RP-HPLC method is designed for the quantitative analysis of Metformin hydrochloride and Saxagliptin in pharmaceutical dosage forms, providing a simple, rapid, precise, and reproducible analytical technique.
What are the key components of the mobile phase used?
The mobile phase consists of a pH 2.5 buffer and Acetonitrile mixed in a ratio of 70:30 v/v, facilitating effective separation of the drugs during chromatographic analysis.
How is the accuracy of the HPLC method validated?
Accuracy is validated through recovery experiments at 50%, 100%, and 150% concentrations. The recovery rates for the drugs should range between 99% to 102%.
What are the retention times for Metformin and Saxagliptin?
The retention times are approximately 2.8 minutes for Metformin hydrochloride and 5.2 minutes for Saxagliptin, ensuring effective separation during the HPLC analysis.
What does the forced degradation study evaluate?
The forced degradation study assesses the stability of Metformin hydrochloride and Saxagliptin under various stress conditions such as thermal, photolytic, hydrolytic, and oxidative conditions.
What are the key findings from the method validation?
The methods showed excellent linearity, precision, accuracy, and robustness, making it suitable for routine pharmaceutical quality control for the combined dosage forms of Saxagliptin and Metformin hydrochloride.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “RP-HPLC method for metformin and saxagliptin: validation and analysis.”. 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 the paper, 'Table' refers to structured data representations that summarize experimental results, results of assays, and system suitability parameters of Metformin Hydrochloride and Saxagliptin. These tables help in conveying results clearly and facilitate the comparison of the outcomes of various experiments conducted during the study.
2) Drug:
'Drug' is a central term in this research, representing the pharmaceutical agents under investigation: Metformin Hydrochloride and Saxagliptin. Both drugs are employed in treating type 2 diabetes, and their analysis highlights the importance of monitoring stability and effectiveness through precise and validated analytical methodologies.
3) Water:
'Water' serves as a fundamental solvent in pharmaceutical preparations, including the buffers used in the HPLC method. It highlights the need for high purity because impurities in water can affect chromatography results, leading to inaccurate determinations of drug concentrations and stability evaluations in the analysis.
4) Performance:
'Performance' pertains to the efficiency and effectiveness of the RP-HPLC method developed for analyzing the drugs. In this context, performance is assessed based on parameters like precision, accuracy, linearity, and robustness, indicating how well the method can produce reliable and repeatable results for the compounds being studied.
5) Nagarjuna:
'Nagarjuna' refers to the Acharya Nagarjuna University in Andhra Pradesh, India, where the research study was conducted. This connection signifies the academic institution's role and contribution to advancing pharmaceutical research and education, highlighting the collaborative effort of the faculty and students involved in the study.
6) India:
'India' is the geographical and cultural context in which the research was carried out. This highlights the significance of local pharmaceutical research in addressing national health issues, particularly diabetes management, and underscores the need for effective quality control methods for pharmaceuticals in the Indian healthcare sector.
7) Study (Studying):
'Study' denotes the systematic investigation conducted to develop and validate the RP-HPLC method for analyzing Metformin Hydrochloride and Saxagliptin. It represents the rigorous scientific process aimed at understanding drug stability and ensuring accurate quantification in pharmaceutical dosage forms, contributing to the broader field of pharmaceutical analysis.
8) Shrinivasa (Shri-nivasa, Srinivasa):
'Srinivasa' refers to Naidu Srinivasa Rao, the primary author of the study. His contributions highlight individual expertise and dedication to improving pharmaceutical practices and ensuring high-quality standards in drug analysis, supporting the pursuit of knowledge in the field of pharmacy and impacting public health positively.
9) Andhra (Amdhra):
'Andhra' designates the specific region in India, Andhra Pradesh, where the research took place. This regional aspect points to the local pharmaceutical industry's significance, particularly in the development and validation of analytical methods vital for drug quality assurance, informing future research directions and local healthcare improvements.
10) Purity:
'Purity' is a critical concept in pharmaceuticals, referring to the absence of contaminants that could affect the quality of drug substances. In this study, purity impacts the accuracy of the HPLC method and is essential for ensuring that the therapeutic agents Metformin and Saxagliptin meet safety and effectiveness standards.
11) Sita (Shita):
'Sita' may refer to the broader context or components related to the research, potentially alluding to related pharmacological studies or findings tied to Saxagliptin, reinforcing the importance of combinational therapies and interdisciplinary approaches in diabetes treatment, drawing from historical or mythological significance in the narrative.
12) Measurement:
'Measurement' revolves around the quantification of drug concentration and assessment of analytical performance in the study. It underlines the precision required in the analytical methods employed, emphasizing the importance of robust and validated techniques to ensure accurate results that can be trusted for clinical applications.
13) Discussion:
'Discussion' addresses the interpretation and implications of the study's results, analyzing the efficacy of the RP-HPLC method and its potential applications. This reflects on the importance of scientific discourse in understanding research outcomes and fostering further advancements in pharmaceutical analysis and clinical practices.
14) Relative:
'Relative' refers to the context of comparing values, such as assessing the efficacy or recovery rates of drugs concerning expected outcomes. This comparative analysis helps quantify performance metrics and establish benchmarks that contribute to understanding stability, quality control, and analytical accuracy crucial for pharmaceuticals.
15) Quality:
'Quality' encapsulates the standard and effectiveness of the pharmaceutical products analyzed in this study. As a constant focus in drug development and manufacturing, maintaining high quality is essential for ensuring the efficacy and safety of medical therapies provided to patients, especially those with chronic conditions like diabetes.
16) Powder:
'Powder' pertains to the state of the pharmaceutical formulations, specifically the crushed tablets containing Metformin and Saxagliptin. The powder form is essential for sample preparation in HPLC analysis, representing a practical aspect of formulating medications to facilitate accurate dosing for therapeutic interventions.
17) Blood:
'Blood' is indirectly referenced as it relates to the therapeutic effects of the studied drugs on blood glucose levels among diabetic patients. Monitoring glucose levels is crucial in diabetes management, and the study's findings aim to inform methods that would ensure effective control of blood sugar levels.
18) Line:
'Line' relates to the linearity of response in the quantitative analysis performed in the study. It indicates the correlation between drug concentration and response on the chromatogram, assuring that the method can accurately reflect varying amounts of the drugs, which is essential for effective pharmaceutical quality assessment.
Other Science Concepts:
Discover the significance of concepts within the article: ‘RP-HPLC method for metformin and saxagliptin: validation and analysis.’. Further sources in the context of Science might help you critically compare this page with similair documents:
High performance liquid chromatography, Quantitative analysis, Retention time, Chromatographic separation, Method validation, Pharmaceutical dosage form, Detection limit, ICH Guideline.