AUC method for UV-Vis estimation of amlodipine and telmisartan.

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Journal name: World Journal of Pharmaceutical Research
Original article title: Uv-visible spectrophotometric estimationofamlodipine besylate and telmisartan by auc method in bulk drug and tablet 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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Original source:

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Author:

M. T. Mohite, R. A. Bhalchakra and K. V. Chandgude


World Journal of Pharmaceutical Research:

(An ISO 9001:2015 Certified International Journal)

Full text available for: Uv-visible spectrophotometric estimationofamlodipine besylate and telmisartan by auc method in bulk drug and tablet dosage form

Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research

Doi: 10.20959/wjpr20197-15020


Download the PDF file of the original publication


Summary of article contents:

Introduction

Hypertension is a critical global health issue, contributing to millions of deaths and significant disability-adjusted life years each year. Effective management often requires the use of antihypertensive agents, including Amlodipine besylate and Telmisartan, which are essential components in combating high blood pressure. Amlodipine, a calcium channel blocker, and Telmisartan, an angiotensin II receptor antagonist, have been widely used to treat hypertension. The development of reliable analytical methods for simultaneously estimating these drugs in bulk and formulations is vital for ensuring proper medication and treatment effectiveness.

AUC Method for Drug Estimation

A simple and reproducible UV spectrophotometric method utilizing the Area Under Curve (AUC) technique has been developed for the simultaneous estimation of Amlodipine besylate and Telmisartan in both bulk drug and tablet dosage forms. This method was validated following ICH guidelines and demonstrated high reliability with mean recoveries exceeding 98%. The method involved recording absorbance at specific wavelengths, with Amlodipine besylate exhibiting a maximum absorption at 360 nm while Telmisartan was measured at 298 nm. The ranges for calibration were established at 5-30 µg/ml for Amlodipine and 1-15 µg/ml for Telmisartan, demonstrating the effectiveness of the AUC method in quantifying both pharmaceuticals in complex matrices.

Method Validation

Precision and accuracy studies were conducted to validate the developed analytical method further. The precision of the method was assessed through intraday and interday studies, yielding low relative standard deviations (% RSD). High coefficients of correlation (0.999 for Amlodipine and 0.998 for Telmisartan) were observed, indicating excellent linearity over the tested concentration ranges. The accuracy was determined by recovery studies at different levels (80%, 100%, and 120%), confirming that the method not only provides precise measurements but is also accurate in quantifying both drugs when mixed or tested separately.

Application to Pharmaceutical Formulations

The newly developed method was successfully applied to commercial tablet formulations, revealing that the drug contents of Amlodipine besylate and Telmisartan were within acceptable limits. The study utilized the pharmaceutical product Amlopres-TL, which contains 5 mg of Amlodipine besylate and 40 mg of Telmisartan. The method's ability to quickly and accurately estimate drug concentrations supports its potential for routine quality control in pharmaceutical laboratories, ensuring that medications meet labeling claims and efficacy standards.

Conclusion

In conclusion, the study presents a novel and efficient UV spectrophotometric AUC method capable of simultaneously estimating Amlodipine besylate and Telmisartan in bulk and tablet forms. The method's validation confirms its simplicity, accuracy, and precision, making it suitable for routine pharmaceutical analysis. With its potential for application in quality control settings, this analytical approach represents a valuable tool in the management of hypertension therapies and supports ongoing efforts to improve patient health outcomes.

FAQ section (important questions/answers):

What is the purpose of this study on Amlodipine besylate and Telmisartan?

The study aims to develop a simple, rapid, and accurate UV-spectrophotometric method for the simultaneous estimation of Amlodipine besylate and Telmisartan in bulk drug form and tablet dosage forms.

What are the methods used for estimating the drugs in this research?

The research utilizes a UV spectrophotometric method, specifically the Simultaneous and Area Under Curve (AUC) methods, to evaluate the concentrations of Amlodipine besylate and Telmisartan.

What solvents were used in this study for drug analysis?

Methanol and distilled water were employed as solvents for the UV spectrophotometric analysis based on the solubility profiles of Amlodipine besylate and Telmisartan.

What concentration ranges were tested for Amlodipine and Telmisartan?

Amlodipine besylate was tested in the range of 5-30 µg/ml, while Telmisartan was assessed in the concentration range of 1-15 µg/ml during the study.

How was the accuracy of the method determined in this study?

The accuracy was evaluated by calculating the recoveries of Amlodipine besylate and Telmisartan after adding known amounts of the drugs, and results were compared to the calibration curve.

What are the conclusions drawn from this research?

The study concludes that the developed UV-spectrophotometric method is simple, precise, rapid, and accurate for the routine estimation of Amlodipine besylate and Telmisartan in both bulk and tablet forms.

Glossary definitions and references:

Scientific and Ayurvedic Glossary list for “AUC method for UV-Vis estimation of amlodipine and telmisartan.”. 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:
'Drugs' is a broader term encompassing pharmaceutical substances like Amlodipine besylate and Telmisartan utilized for therapeutic purposes. The study focuses on these specific drugs, emphasizing the need for precise measurement techniques in the field of pharmacy, thereby ensuring proper dosage and effectiveness for patient treatment.

2) Study (Studying):
The 'study' denotes the systematic investigation conducted to develop a reliable method for estimating two specific drugs using UV-visible spectrophotometry. The methodology, results, and validation are presented rigorously, ensuring that the findings contribute meaningful knowledge to pharmaceutical sciences, particularly in drug analysis and quality control.

3) Water:
In the context of this research, 'water' is crucial as a solvent used in the preparation of solutions for UV spectroscopy. Distilled water's purity ensures that the measurements are not affected by contaminants. This choice reflects best practices in analytical chemistry, impacting the accuracy and reproducibility of results.

4) India:
'India' signifies the geographical and cultural context of the study, where both the research team and the pharmaceutical industry are located. The pharmaceutical market in India is significant for drug development, especially generics, which is crucial for addressing health issues like hypertension prevalent in the population.

5) Table:
'Table' refers to the tabulated results that present findings from the study, including optical characteristics and recovery rates for Amlodipine besylate and Telmisartan. Tables are essential for summarizing data clearly, facilitating comparison and analysis, and making it easier for researchers to interpret the outcomes of the experiments.

6) Maharashtra (Maharastra, Maha-rashtra):
'Maharashtra' is the Indian state where the research was conducted, indicating the regional influence on healthcare practices and pharmaceutical education. The state is home to several educational and pharmaceutical institutions, which contribute to drug research and development, making it a critical area for advancements in health sciences.

7) Calculation:
'Calculation' pertains to the mathematical processes involved in analyzing the data obtained from spectroscopy. This includes determining concentration levels, recovery percentages, and integrating area under the curve (AUC). Accurate calculations are foundational to deriving meaningful conclusions from experimental data, influencing the validity of the study's results.

8) Discussion:
'Discussion' is a critical section where the authors interpret their findings in the context of existing literature and clinical significance. It allows the research to be framed within the broader scope of pharmaceutical sciences, helping to understand how the findings impact clinical practices and further research directions.

9) Disease:
'Disease' refers to hypertension, the medical condition addressed in the study. Hypertension is a significant public health issue globally, contributing to mortality and morbidity. Understanding the effective management of hypertension through proper pharmaceutical techniques is vital for improving patient care and reducing healthcare burdens related to cardiovascular diseases.

10) Powder:
'Powder' relates to the form of the drug samples used in the study. The drugs Amlodipine besylate and Telmisartan were prepared in powdered form for analysis, facilitating accurate measurement and dissolution for UV spectroscopy. This aspect is essential for ensuring consistent drug performance across various formulations.

11) Patil:
'Patil' refers to Dr. D.Y. Patil College of Pharmacy, where the research team is based. The institution plays a significant role in pharmaceutical education and research in India, highlighting the academic foundation necessary for conducting high-quality, impactful research that contributes to the field of pharmacy.

12) Death:
'Death' underscores the serious consequences associated with untreated hypertension, which can lead to cardiovascular events and mortality. This highlights the urgency of effective drug management strategies and the importance of developing reliable methods for drug estimation, as this can directly impact patient outcomes and survival rates.

13) Blood:
'Blood' is central to the context of hypertension, as blood pressure is a critical indicator of health. The study of blood pressure management through specific drugs such as Amlodipine besylate and Telmisartan emphasizes the need for effective treatments to prevent adverse cardiovascular events and ensure overall health.

14) Pune:
'Pune' is the city in Maharashtra where the research was conducted and where Dr. D.Y. Patil College of Pharmacy is located. The city's growth in the pharmaceutical industry and education contributes to significant advancements in drug research, aiming to improve healthcare outcomes both locally and globally.

15) Relative:
'Relative' usually pertains to comparisons made in the analysis, such as relative standard deviation (RSD), which measures precision in the study. Understanding relative relationships in data helps to ascertain the reliability and reproducibility of the analytical technique, which is critical for method validation in pharmaceutical analysis.

16) Channel:
'Channel' refers to the specific pathways that pharmacological agents like Amlodipine, a calcium channel blocker, utilize to exert their therapeutic effects. Understanding these biological mechanisms aids in drug development and helps refine treatment strategies for conditions like hypertension, emphasizing the importance of such knowledge in pharmacy.

17) Life:
'Life' relates to the broader implications of hypertension management through effective pharmaceutical interventions. Improving life quality through effective treatment strategies underscores the importance of pharmaceutical research, showcasing how advancements in drug estimation can enhance patient care and address vital health challenges in society.

Other Science Concepts:

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Discover the significance of concepts within the article: ‘AUC method for UV-Vis estimation of amlodipine and telmisartan.’. Further sources in the context of Science might help you critically compare this page with similair documents:

Experimental method, Research article, Recovery study, Calibration curve, Statistical validation, Pharmaceutical dosage form, Telmisartan, Experimental Condition.

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