RP-HPLC method for estimating chlorthalidone, amlodipine, and olmesartan.
Journal name: World Journal of Pharmaceutical Research
Original article title: Method development and validation of rp-hplc method for simultaneous estimation of chlorthalidone hydrochloride, amlodipine besylate and olmesartan medoxomil in bulk and combined tablets dosage forms
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.
This page presents a generated summary with additional references; See source (below) for actual content.
Original source:
This page is merely a summary which is automatically generated hence you should visit the source to read the original article which includes the author, publication date, notes and references.
Shweta Hingde and Dr. Snehalatha Boddu
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: Method development and validation of rp-hplc method for simultaneous estimation of chlorthalidone hydrochloride, amlodipine besylate and olmesartan medoxomil in bulk and combined tablets dosage forms
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
Doi: 10.20959/wjpr20176-8533
Download the PDF file of the original publication
Summary of article contents:
Introduction
The article outlines the development and validation of a high-performance liquid chromatography (HPLC) method for the simultaneous estimation of Chlorthalidone Hydrochloride, Amlodipine Besylate, and Olmesartan Medoxomil in bulk and combined tablet dosage forms. This combination of drugs is commonly used in the treatment of hypertension and angina pectoris. The study emphasizes the importance of efficient analytical techniques for the assessment of pharmaceutical formulations, particularly as hypertension continues to be a leading global health issue.
Method Development and Validation
The HPLC method described in the study employs a Prontosil C18 column with a mobile phase consisting of 0.02 M potassium dihydrogen phosphate and acetonitrile (60:40) at a pH of 3.0. The flow rate is maintained at 1 ml/min, and the method demonstrates a retention time of 3.017 mins for Chlorthalidone, 3.313 mins for Amlodipine, and 5.010 mins for Olmesartan. The method showed linearity across specified concentration ranges for each drug, with calibration curves confirming high correlation coefficients, indicating that the method is both precise and reliable.
Accuracy and Precision
The study thoroughly examines the accuracy and precision of the HPLC method through recovery studies and precision assessments. Recovery studies reveal percentages above 98% for all three drugs, suggesting excellent accuracy in quantifying drugs from pharmaceutical preparations. Precision is evaluated through intraday and interday variations, showcasing low relative standard deviation (RSD) values (<2%), indicating high reproducibility of results. Thus, the method can be trusted for consistent and accurate analysis.
Robustness and Detection Limits
The robustness of the method was tested by making slight variations to method parameters such as flow rate, mobile phase composition, and wavelength. Results indicated that such changes did not significantly affect the retention time or the tailing factor, reinforcing the reliability of the method. The limits of detection (LOD) and quantitation (LOQ) were also established, providing quantitative benchmarks for the presence of these drugs in various formulations, thus enhancing the method's applicability in quality control settings.
Conclusion
The developed RP-HPLC method is significant as it represents the first comprehensive approach for the simultaneous estimation of Chlorthalidone Hydrochloride, Amlodipine Besylate, and Olmesartan Medoxomil. It yields results that are accurate, precise, and reproducible, making it an invaluable tool for routine quality assurance in pharmaceutical laboratories. Given the method's demonstrated superiority over existing spectrophotometric techniques, it holds great potential for broad application in clinical and quality control laboratories for hypertension medications.
FAQ section (important questions/answers):
What is the purpose of the developed RP-HPLC method?
The RP-HPLC method was developed for the simultaneous estimation of Chlorthalidone Hydrochloride, Amlodipine Besylate, and Olmesartan Medoxomil in bulk and combined tablet dosage forms.
What are the benefits of using this HPLC method?
This method is accurate, selective, and reproducible, with recovery rates above 98%. It provides a convenient option for analyzing multiple drugs simultaneously in pharmaceuticals.
What were the key findings for retention times in the study?
The retention times were 3.017 mins for Chlorthalidone HCl, 3.313 mins for Amlodipine Besylate, and 5.010 mins for Olmesartan Medoxomil, indicating effective separation.
How was the accuracy of the method assessed?
Accuracy was evaluated through recovery studies at different levels, yielding recovery rates of 99% for Chlorthalidone, 100.20% for Amlodipine, and 98.97% for Olmesartan.
What were the linearity range results in this study?
The linearity ranges were 26.75-38 µg/ml for Chlorthalidone, 7.5-20 µg/ml for Amlodipine, and 30-80 µg/ml for Olmesartan, with high correlation coefficients.
What is the significance of the recovery studies conducted?
Recovery studies showed excellent accuracy and precision, demonstrating that the developed HPLC method is reliable for quality control in pharmaceutical analysis.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “RP-HPLC method for estimating chlorthalidone, amlodipine, and olmesartan.”. 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 refers to a structured arrangement of data presented in rows and columns, often used in research papers to summarize important findings, experiment results, or comparisons. In this context, tables showcase various analytical results such as system suitability parameters, linearity data, and accuracy studies, enabling readers to easily comprehend the information and draw conclusions.
2) Drug:
Drug signifies any substance used to diagnose, treat, or prevent a disease or medical condition. In this research, drugs like Chlorthalidone Hydrochloride, Amlodipine Besylate, and Olmesartan Medoxomil are studied for their effectiveness in managing hypertension. Understanding drug properties and interactions is crucial for developing effective treatment protocols.
3) Quality:
Quality refers to the standard of something measured against other things of a similar kind. In pharmaceutical research, quality is essential to ensure that drugs meet safety, efficacy, and regulatory standards. The method validation in this study emphasizes the need for high-quality analytical techniques to ensure reliable results in drug analysis.
4) Study (Studying):
Study entails the process of examining, researching, or analyzing a subject or phenomenon. This research study focuses on method development and validation for analyzing multiple drugs simultaneously. Understanding the study design and methodology is crucial for evaluating the reliability of the results and their applicability in real-world situations.
5) Relative:
Relative refers to the relationship between different entities, often concerning measurements or comparisons. In the context of the study, relative standard deviation (RSD) is used as a statistical measure to calculate the precision of the analytical method. It helps in assessing the reproducibility of results, providing confidence in the methodological approach.
6) Disease:
Disease refers to an abnormal condition affecting the bodily functions, often associated with specific symptoms and signs. In this research, the diseases under consideration are hypertension and angina pectoris. Understanding these diseases aids in the development of effective treatments, supporting the rationale for analyzing the studied drugs' efficacy.
7) Water:
Water, in the context of this study, refers to the solvent used in preparing solutions for high-performance liquid chromatography (HPLC). The quality and purity of water are significant, as it can impact the results of the chromatography process. It is essential to use HPLC-grade water to ensure accurate and reproducible analytical outcomes.
8) Performance:
Performance signifies how well a method or instrument functions in achieving desired results. In this study, the performance of the developed RP-HPLC method is critical for assessing its effectiveness in analyzing the specified drugs. Key performance indicators include accuracy, precision, and robustness, determining the method’s suitability for routine analysis.
9) Discussion:
Discussion involves evaluating and interpreting research findings in the context of existing literature. In this article, the discussion section highlights the significance of the developed method, compares it to previous works, and underscores its practical applications in pharmaceutical analysis. This critical assessment aids in understanding the study’s impact on the field.
10) Channel:
Channel can refer to a pathway for fluids or communications. In HPLC, the channel relates to the flow of the mobile phase through the chromatographic column. Understanding the channel dynamics is vital for optimizing separation processes and achieving efficient resolution of the analytes being studied.
11) Thomas:
Thomas refers to a brand name, likely indicating the supplier of certain reagents or materials used in the study. In research, sourcing from reputable brands ensures the quality and consistency of reagents like solvents. The choice of suppliers like Thomas Baker indicates a commitment to high standards in the experimental process.
12) Powder:
Powder in the context of pharmaceutical analysis refers to the finely ground substance derived from solid drugs, such as tablets that are being analyzed. The powder must be accurately measured for preparing sample solutions. Proper powder preparation is crucial for ensuring that the analytical method accurately reflects the drug's concentration.