RP-HPLC method for simultaneous analysis of aspirin and omeprazole.

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Journal name: World Journal of Pharmaceutical Research
Original article title: Formation and validation of an analytical method for the simultaneous assessment of aspirin and omeprazole in tablet dosage form by rp-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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Author:

Atif Ali, Asia Kiran, Zahid Mehboob, Dr. Syed Alam Zeb, Sadaf Ismat, Sayed Muzahir Hussain, Zulfiqar Ahmad and Muhammad Mudassar Ali


World Journal of Pharmaceutical Research:

(An ISO 9001:2015 Certified International Journal)

Full text available for: Formation and validation of an analytical method for the simultaneous assessment of aspirin and omeprazole in tablet dosage form by rp-hplc

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

Doi: 10.20959/wjpr20214-20018

Copyright (license): WJPR: All rights reserved


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Summary of article contents:

Introduction

Cardiovascular disease (CVD) remains the leading cause of mortality in the United States, prompting the need for effective treatment options. Aspirin is widely recognized for its role in preventing CVD, but it carries the risk of gastrointestinal (GI) bleeding, particularly in high-risk patients. This risk has led to the exploration of combining aspirin with proton pump inhibitors (PPIs) like Omeprazole, which can mitigate these adverse effects. The USFDA approved Yosprala, a tablet that combines immediate-release Omeprazole and delayed-release Aspirin, to enhance cardiovascular and GI safety.

Development of a Reliable Analytical Method

A significant aim of the study was the development of an efficient and reliable analytical method using reverse phase high-performance liquid chromatography (RP-HPLC) for the simultaneous quantification of Aspirin and Omeprazole in tablet form. The RP-HPLC method utilizes a PHENOMENEX C8 column for separation, with a mobile phase composed of a phosphate buffer and acetonitrile in a 75:25 ratio, adjusted to a pH of 7.5. The method demonstrated consistent retention times for both drugs—2.2 minutes for Aspirin and 8.4 minutes for Omeprazole—indicating effective separation and quantification.

Validation of the Method

Validation of the developed HPLC method included assessments of accuracy, precision, linearity, and robustness adhering to International Council for Harmonisation (ICH) and United States Pharmacopeia (USP) guidelines. The method exhibited a strong linear correlation with coefficients of 0.9996 for both Aspirin and Omeprazole. The relative standard deviation (RSD) was less than 2.0%, establishing the method's precision and reliability. Further, the limits of detection (LOD) and quantification (LOQ) for both drugs were determined, underscoring the method's suitability for quality control in pharmaceutical applications.

Assessment of Drug Efficacy

The study also emphasized the clinical relevance of combining Aspirin and Omeprazole, particularly in patients requiring dual antiplatelet therapy. Omeprazole provides gastric protection that can reduce gastrointestinal complications associated with Aspirin usage. The combination therapy not only helps to maintain antiplatelet effects but also enhances patient adherence by alleviating dyspeptic symptoms. The protective role of PPIs in preventing Aspirin-induced gastric bleeding has been corroborated by various studies, enhancing its importance in clinical practice.

Conclusion

In summary, the research successfully developed and validated an analytical method for quantifying Aspirin and Omeprazole in tablet dosage forms using RP-HPLC, adhering to strict pharmaceutical guidelines. The method proved to be accurate, precise, and capable of addressing the challenges of concurrent medication management in high-risk cardiovascular patients. The study underscores the significance of Yosprala as a therapeutic option that combines the antiplatelet effects of Aspirin with the protective qualities of Omeprazole against gastrointestinal bleeding, thereby promoting safer and more effective patient care strategies in cardiovascular medicine.

FAQ section (important questions/answers):

What is the purpose of the study conducted by Ali et al.?

The study aimed to develop a reliable and sensitive reverse-phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous assessment of Aspirin and Omeprazole in tablet dosage forms.

What is Yosprala and its significance in this research?

Yosprala is a newly developed tablet combining immediate-release Omeprazole and delayed-release Aspirin. It is effective for cardiovascular and gastrointestinal protection, approved by the USFDA in September 2016.

What was the analytical method employed in this study?

The researchers used RP-HPLC with a PHENOMENEX C8 column. The method involved a mobile phase consisting of a 75:25 phosphate buffer and acetonitrile mixture, ensuring effective separation of Aspirin and Omeprazole.

What were the retention times found for Aspirin and Omeprazole?

The retention time for Aspirin was 2.2 minutes, while Omeprazole had a retention time of 8.4 minutes, indicating effective separation between the two compounds during analysis.

How was the validation of the analytical method conducted?

The method was validated for parameters such as accuracy, precision, specificity, and robustness, with less than 2.0% relative standard deviation (RSD) observed for both Aspirin and Omeprazole.

What are the key benefits of the developed analytical method?

The developed RP-HPLC method is simple, cost-effective, and durable, providing reliable results for the simultaneous quantification of Aspirin and Omeprazole in tablet dosage forms.

Glossary definitions and references:

Scientific and Ayurvedic Glossary list for “RP-HPLC method for simultaneous analysis of aspirin and omeprazole.”. 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 are substances used to diagnose, cure, treat, or prevent diseases. This term encompasses a wide range of compounds, including prescription medications, over-the-counter products, and recreational substances. The paper focuses on the mutual interaction between Aspirin and Omeprazole, which are essential for treating cardiovascular issues and preventing gastral lesions.

2) Table:
Table signifies a structured way to display scientific data for clarity and comparison. In this study, 'tablet dosage form' refers to a compact form of medication containing active ingredients like Aspirin and Omeprazole. Tables are common in research to summarize findings, including results from drug analysis and method validations.

3) Disease:
Diseases are pathological conditions characterized by an abnormal state affecting the body. The article specifically refers to cardiovascular and gastrointestinal diseases, which are essential in understanding patient management strategies. The highlighted drugs, Aspirin and Omeprazole, are utilized for their dual efficacies in treating these prevalent health issues.

4) Water:
Water is a vital solvent in biochemical processes and is commonly used in pharmaceutical formulations. In this context, distilled water is employed in preparing solutions for HPLC analysis, ensuring the purity and efficacy of drug assessments. Its role as a diluent demonstrates its fundamental importance in laboratory settings.

5) Bleeding:
Bleeding refers to the escape of blood from the circulatory system. In the study, the adverse effect of Aspirin, which can increase the risk of gastrointestinal bleeding, is discussed. This highlights the need for careful therapeutic management, especially when combining with protective agents like Omeprazole to mitigate risks.

6) Science (Scientific):
Science encompasses the systematic study of the structure and behavior of the physical and natural world. In this context, it relates to the biomedical and pharmaceutical sciences crucial for developing and validating effective drug therapies. The research exemplifies the application of scientific methods in drug analysis.

7) Lahore:
Lahore is a major city in Pakistan that houses various educational and research institutions. This paper mentions the University of Lahore, signifying its contribution to pharmaceutical research and education. Collaborations within university settings play a crucial role in advancing healthcare and drug development in the region.

8) Ulcer:
Ulcer, singularly, denotes the physical manifestation of a sore that can disrupt normal bodily functions, particularly within gastrointestinal contexts. The study's exploration of the protective role of Omeprazole against ulcers illustrates the need for careful prescribing habits to manage associated risks effectively.

9) Death:
Death represents the end stage of life and can be the ultimate consequence of uncontrollable diseases or adverse drug effects. In the context of this study, the connection between cardiovascular disease and mortality rates emphasizes the importance of effective treatment strategies to reduce risks of death associated with these conditions.

10) Pharmacological:
Pharmacological refers to the study of drug action and how drugs interact within biological systems. This research delves into the pharmacological interactions between Aspirin and Omeprazole, illustrating the significance of understanding drug mechanisms to optimize therapeutic outcomes and minimize adverse effects for patients.

11) Accumulation (Accumulating, Accumulate):
Accumulation highlights the gradual build-up of substances, particularly in biological systems. In pharmacology, it can refer to the retention of a drug or its metabolites within the body. The study considers accumulation's role in drug interactions, particularly focusing on how Aspirin affects patients requiring long-term therapy.

12) Calculation:
Calculation involves the mathematical determination of values, essential for analyzing drug concentrations, dosages, and efficacy. In this study, calculations are applied to validate the HPLC method used for quantifying Aspirin and Omeprazole, ensuring precision in drug measurement critical for therapeutic effectiveness.

13) Performance:
Performance refers to how effectively a drug or treatment achieves its intended outcomes. This study evaluates the performance of an analytical method for quantifying drug concentrations, thereby helping ensure that the active ingredients in Yosprala are present in therapeutic doses to maximize patient safety and efficacy.

14) Discussion:
Discussion usually signifies the analytical dialogue surrounding study findings. This section allows researchers to interpret results, compare with existing literature, and theorize on implications. In this study, discussions would focus on the implications of the findings regarding the efficacy and safety of Aspirin and Omeprazole in clinical practice.

15) Peshawar:
Peshawar is another prominent city in Pakistan, home to various educational and pharmaceutical institutions. Mentioning Peshawar indicates the diversity of research contributions across Pakistan. Universities in these cities play a crucial role in local healthcare advancements and aim to produce relevant pharmaceutical studies and developments.

16) Activity:
Activity often references the effect of a drug, particularly how it interacts with biological targets to produce therapeutic effects. The article discusses the antiplatelet activity of Aspirin and the inhibitory action of Omeprazole, emphasizing their clinical significance in treating cardiovascular and gastrointestinal disorders.

17) Relative:
Relative indicates how one element compares to another within a given context. In pharmacological studies, it often reflects comparative data between drug efficacy or adverse effects. For example, the relative effectiveness of Aspirin in preventing thrombotic events compared to other antiplatelet drugs is essential for treatment decisions.

18) Campu:
Campu likely refers to 'Campus', a term used to denote the grounds of an educational institution. It emphasizes the academic setting in which research is conducted, indicating collaboration and access to resources necessary for developing effective pharmaceutical methodologies and fostering innovative research in healthcare.

19) Rules:
Rules represent the established guidelines that govern scientific research and methodologies. In this context, rules from organizations such as ICH and USP are cited, which guide the standardization and validation of pharmaceutical methods, ensuring data reliability and patient safety in drug development.

20) Study (Studying):
Study denotes the careful examination of scientific concepts through research. In this manuscript, the study investigates the method development and validation for quantifying Aspirin and Omeprazole, contributing valuable insights to pharmaceutical science and improving the understanding of combined drug therapies for enhanced patient care.

21) Alam (Alaṁ):
Alam, referring to a likely key contributor in the study, emphasizes the collaborative nature of scientific research. The mention of various authors underscores the importance of teamwork in bringing together diverse expertise to tackle complex issues in pharmaceutical development and optimize treatment strategies.

Other Science Concepts:

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Discover the significance of concepts within the article: ‘RP-HPLC method for simultaneous analysis of aspirin and omeprazole.’. Further sources in the context of Science might help you critically compare this page with similair documents:

Analytical method, Impact factor, Bioavailability, Cardiovascular disease, Dosage form, Mobile phase, Linearity range, Gastrointestinal bleeding, Proton Pump Inhibitor, Incidence rate, RP-HPLC Method, Method validation, Phosphate buffer, Recovery Rate.

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