RP-HPLC method for metformin and sitagliptin analysis.
Journal name: World Journal of Pharmaceutical Research
Original article title: Stability-indicating rp-hplc method and its validation for analysis of metformin hydrochloride & sitagliptin phosphate 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 & sitagliptin phosphate 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
This study presents a newly developed and validated reverse phase high-performance liquid chromatography (RP-HPLC) method for the quantitative analysis of Metformin hydrochloride and Sitagliptin Phosphate in pharmaceutical dosage forms. Metformin and Sitagliptin are both critical medications used in the treatment of type 2 diabetes, and their simultaneous analysis is crucial for quality control in pharmaceutical preparations. The method focuses on various aspects such as sensitivity, precision, and reproducibility, ensuring its applicability in a routine laboratory setting.
Method Development and Validation
The RP-HPLC method was optimized using a Zodiac C18 column with a mobile phase comprising a triethylamine (TEA) buffer and methanol in a ratio of 80:20 v/v. The flow rate was set at 1.0 ml/min, with detection occurring at 224 nm. The method exhibited excellent linearity with correlation coefficients of 0.999 for both Metformin (80-730 µg/ml) and Sitagliptin (8-70 µg/ml). ICH guidelines were used to validate the method, confirming it as suitable for measuring these compounds in bulk and dosage forms.
Forced Degradation Studies
To assess the stability of the compounds, forced degradation studies were executed under various stress conditions, such as thermal, photolytic, hydrolytic, acid, alkali, and oxidative stress. The results indicated that both Metformin and Sitagliptin were relatively stable under most conditions, with specific degradation percentages noted. This analysis is vital for understanding the stability of these drugs in pharmaceutical formulations, which assures their efficacy and safety throughout their shelf life.
Precision and Accuracy
The method's precision was determined through intra-day and inter-day testing, where the relative standard deviations (RSD) for both Metformin and Sitagliptin were found to be well within the acceptable limit of 2.0%. Additionally, accuracy was examined through recovery studies, which showed a recovery rate ranging from 99.1% to 100.4% for Metformin and 98.3% to 99.4% for Sitagliptin at varying concentrations. These metrics underscore the reliability of the method in providing precise and accurate measurements essential for quality control processes.
Conclusion
In conclusion, the developed RP-HPLC method provides a simple, sensitive, and reproducible approach for the simultaneous quantification of Metformin hydrochloride and Sitagliptin Phosphate in pharmaceutical preparations. The successful validation confirming its specificity, precision, accuracy, and robustness positions this method as an effective tool for routine analysis in pharmaceutical laboratories. Such methodologies contribute significantly to maintaining the quality and safety of diabetes medications, supporting their effective management in patient care.
FAQ section (important questions/answers):
What is the purpose of the developed RP-HPLC method?
The developed RP-HPLC method aims to quantitatively analyze Metformin hydrochloride and Sitagliptin Phosphate in pharmaceutical dosage forms, providing a simple, rapid, and accurate technique for stability-indicating results.
How were Metformin and Sitagliptin separated chromatographically?
Chromatographic separation of Metformin and Sitagliptin was achieved using a Zodiac C18 column and a mobile phase consisting of TEA buffer and Methanol in an 80:20 v/v ratio.
What were the retention times for Metformin and Sitagliptin?
The retention times observed were 3.6 minutes for Metformin hydrochloride and 5.3 minutes for Sitagliptin Phosphate during the HPLC analysis.
What was the correlation coefficient of the method's linearity?
The correlation coefficient for the method's linearity ranged between 0.9956 to 0.9993 for Sitagliptin Phosphate and Metformin hydrochloride, indicating excellent linearity.
What validation parameters were used for the method?
The method was validated based on accuracy, linearity, precision, robustness, detection limits, quantitation limits, and specificity according to ICH guidelines.
What are the potential applications of this RP-HPLC method?
This RP-HPLC method can be applied for routine analysis and quality control of pharmaceuticals containing Metformin hydrochloride and Sitagliptin Phosphate in combined dosage forms.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “RP-HPLC method for metformin and sitagliptin 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:
Table in this context refers to the structured presentation of data, including assay results and forced degradation studies. Tables organize important results of the study, enabling quick reference and comparison of values such as drug recovery percentages, area counts, and method validation parameters, contributing to the scientific rigor of the research.
2) Drug:
Drug pertains to the pharmacological substances Metformin hydrochloride and Sitagliptin Phosphate discussed in the study. Both drugs are utilized in managing type 2 diabetes. Understanding their chemical analysis is crucial for ensuring efficacy, safety, and stability, which is central to the research objectives of the paper.
3) Water:
Water is used in the preparation of buffers and diluents necessary for the reverse phase high-performance liquid chromatography (RP-HPLC) method. The quality of water can affect the chromatography outcomes. Adequate control over its purity is vital to achieve reproducible and reliable analytical results in pharmaceutical research.
4) Sita (Shita):
Sita likely references Sitagliptin Phosphate, one of the two primary drugs studied. It serves as a DPP-4 inhibitor to manage glucose levels in diabetes patients. The study focuses on its analytical validation, ensuring accurate quantification and stability, making it relevant in both pharmacological and analytical chemistry domains.
5) Performance:
Performance in this context refers to the effectiveness of the developed RP-HPLC method in quantifying the drugs accurately and consistently. Key performance indicators include sensitivity, precision, and recovery rates, all of which ensure that the method meets required standards for routine quality control in pharmaceutical testing.
6) Nagarjuna:
Nagarjuna references Acharya Nagarjuna University, an educational institution in Andhra Pradesh, India. The university provided resources and facilities for the research conducted by the authors. It signifies the academic foundation and collaborative efforts that contributed to the successful development and validation of the analytical method discussed.
7) Zodiac:
Zodiac refers to the specific C18 column used in the RP-HPLC method which is essential for achieving separation between Metformin hydrochloride and Sitagliptin Phosphate. The choice of column affects resolution and efficiency, making it a critical component in analytical procedures, contributing to the quality of the research findings.
8) India:
India is the geographical context where the research was conducted, particularly at Acharya Nagarjuna University. The significance lies in the need for effective diabetes management solutions in India’s healthcare landscape, reflecting local health issues that the investigation aims to address through advanced analytical methodologies for drug stability.
9) Study (Studying):
Study pertains to the research conducted to develop and validate an RP-HPLC method for analyzing the two drugs. It highlights the systematic investigation, including methodology, results, and discussions around drug stability and quantification. The rigor of the study is vital for establishing scientific credibility and practical applications.
10) Shrinivasa (Shri-nivasa, Srinivasa):
Srinivasa refers to the lead author Naidu Srinivasa Rao, who contributed significantly to the research. The mention of authorship attributes expertise and responsibility for the validity of the findings. It also underscores academic collaboration and the importance of scholarly contributions in advancing pharmaceutical research methodologies.
11) Andhra (Amdhra):
Andhra refers to Andhra Pradesh, the Indian state housing Acharya Nagarjuna University and the research conducted there. The mention draws attention to the region’s role in the healthcare sector, specifically diabetes management, highlighting the local relevance of the research outcomes on pharmaceutical practices in the state.
12) Purity:
Purity relates to the assessment of drug samples and the solvents used in the RP-HPLC analysis. High purity is essential in chemical analysis to avoid interference with chromatography results, ensuring that the peaks in chromatograms accurately reflect the pharmacological substances' concentrations, which is fundamental for validation.
13) Measurement:
Measurement pertains to the quantification of drug concentrations through the RP-HPLC method. Accurate measurement is crucial for ensuring proper dosing and effectiveness of the drugs analyzed. This implies the importance of analytical precision in pharmaceutical studies, influencing treatment outcomes and ensuring regulatory compliance in drug quality.
14) Discussion:
Discussion refers to the section of the paper where findings are interpreted and contextualized within existing literature. It evaluates the significance of the study results, limitations, and practical applications. The discussion provides insights into the implications of the research for future studies and the pharmaceutical industry.
15) Relative:
Relative in this context usually describes the comparison of results such as recovery rates or standards measured against control values. It emphasizes the importance of evaluating results against set benchmarks to determine method efficacy and reliability, ensuring that conclusions drawn are meaningful in the context of the study.
16) Quality:
Quality refers to the standard of the RP-HPLC method developed and the drug products analyzed. Quality checks in pharmaceutical analysis ensure that products meet safety and efficacy requirements, which is critical for patient care and regulatory approvals, emphasizing the integrity of pharmaceutical practices and research outcomes.
17) Powder:
Powder typically refers to the form of Metformin hydrochloride and Sitagliptin Phosphate used in the assays. Preparation of the powdered form for analysis is a critical step in the methodology that ensures consistent dosing and accurate quantification, reflecting the importance of proper sample preparation in analytical chemistry.
18) Blood:
Blood relates to the clinical relevance of both drugs, Metformin and Sitagliptin, used for controlling glucose levels in diabetic patients. Although blood testing is not the focus of the study, the effective monitoring and control of blood glucose are the ultimate goals of employing these pharmaceuticals, linking research to patient health.
19) Line:
Line in this context refers to the calibration curves used in the method validation, illustrating the relationship between drug concentration and chromatographic response. Establishing a reliable linearity is pivotal for quantitative analysis, ensuring that the method can accurately determine concentrations across specified ranges, which is essential in pharmaceuticals.
Other Science Concepts:
Discover the significance of concepts within the article: ‘RP-HPLC method for metformin and sitagliptin analysis.’. Further sources in the context of Science might help you critically compare this page with similair documents:
Quality Control, High performance liquid chromatography, Quantitative analysis, Chromatogram, Analytical grade, Retention time, Mobile phase, Correlation coefficient, Ambient temperature, Chromatographic separation, Limit of detection, Pharmaceutical formulation, Method validation, Pharmaceutical dosage form, Limit of quantitation, Stock Solution, Recovery experiment, Chromatographic condition, Sodium bicarbonate, Detection limit.