RP-HPLC method for estimating omeprazole and piperine.

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Journal name: World Journal of Pharmaceutical Research
Original article title: Development and validation of rp-hplc method for simultaneous estimation of omeprazole and piperine in bulk 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:

Pavani Challamalla, C.Vanitha, Ananthula Swapna, CH.Srinivas Reddy, S.Damayanthi and J. Satya narayana


World Journal of Pharmaceutical Research:

(An ISO 9001:2015 Certified International Journal)

Full text available for: Development and validation of rp-hplc method for simultaneous estimation of omeprazole and piperine in bulk 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 the development and validation of a novel isocratic High Performance Liquid Chromatography (HPLC) method for the simultaneous estimation of Omeprazole and Piperine in their bulk forms. Conducted by Pavani Challamalla et al., the research aimed to create a method that is not only accurate and precise but also rapid and cost-effective. The method utilizes a Waters HPLC system with specific chromatographic conditions, making it suitable for the quantitative analysis of the two compounds.

Methodology and Optimization of Chromatographic Conditions

The optimized chromatographic conditions included the use of an XTerra RP8 Column with a mobile phase composed of acetonitrile and phosphate buffer in a 55:45 ratio. The analysis flow rate was set at 1 ml/min and detection occurred at 240 nm. The retention times for Omeprazole and Piperine were recorded at 2.767 minutes and 4.029 minutes, respectively. The method demonstrated strong linearity within the concentration range of 10-50 µg/ml for both components, solidifying its effectiveness for simultaneous estimation.

Validation and Precision of the Method

The newly developed HPLC method underwent rigorous validation, which included tests for accuracy, precision, linearity, and robustness as per ICH guidelines. Intraday and inter-day precision studies resulted in % Relative Standard Deviations (RSD) of less than 1.00, indicating high precision. Recovery studies showed mean values between 98% and 102%, confirming the method's reliability. The system suitability tests revealed good parameters, such as a Tailing factor of approximately 1.4 and a significant number of theoretical plates for both compounds.

Robustness and Detection Limits

The method's robustness was established by making small changes in factors such as flow rate and mobile phase composition, which did not have a significant impact on retention times or peak areas. Moreover, the limits of detection (LOD) and quantification (LOQ) for Omeprazole and Piperine were determined, with low concentration values indicating the method's sensitivity. This robustness and sensitivity make the method applicable in various pharmaceutical situations.

Conclusion

In conclusion, the RP-HPLC method developed for the simultaneous estimation of Omeprazole and Piperine in bulk form showcases its promise as a simple, precise, and economical tool for pharmaceutical analysis. The successful validation of the method across multiple parameters signifies its applicability in routine quality control of these drugs. The authors express their gratitude to Piramal, Mumbai, for providing the necessary samples, contributing to the advancement of analytical techniques in pharmaceutical research.

FAQ section (important questions/answers):

What is the main purpose of the developed RP-HPLC method?

The RP-HPLC method was developed for the simultaneous estimation of Omeprazole and Piperine in bulk form, ensuring accuracy, precision, and reliability in their analysis.

What are the key components of the mobile phase used in this method?

The mobile phase consisted of Acetonitrile and Phosphate buffer in a 55:45 ratio, allowing efficient separation during high-performance liquid chromatography.

What were the retention times for Omeprazole and Piperine?

The retention time for Omeprazole was 2.767 minutes and for Piperine it was 4.029 minutes, indicating effective separation during the chromatographic analysis.

How was the accuracy of the method validated?

The accuracy was validated through recovery studies at different concentration levels, yielding mean recovery values between 98.0% and 101.9%, confirming the method's reliability.

What did the linearity results indicate in this study?

Linearity results showed a strong correlation coefficient (r = 0.999) between the concentrations of Omeprazole and Piperine and their corresponding peak areas, demonstrating the method's effectiveness.

What are the implications of method robustness in this study?

Method robustness implies that minor changes in flow rate and mobile phase composition do not significantly affect retention time and peak area, ensuring consistency in results.

Glossary definitions and references:

Scientific and Ayurvedic Glossary list for “RP-HPLC method for estimating omeprazole and piperine.”. 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 research articles, a table organizes data in a structured format for easy comparison and analysis. It presents numerical or categorical information clearly, allowing readers to quickly interpret results, such as precision, accuracy, and linearity data in the discussed RP-HPLC method. Tables enhance the understanding of complex data.

2) Pavani:
Pavani refers to the lead author of the study. In academic research, the author’s name is significant as it lends credibility to the research findings. The contributions of Pavani and co-authors in developing and validating the RP-HPLC method for drug estimation highlight their expertise and dedication to pharmaceutical research.

3) Drug:
Drugs are substances used for medical treatment to prevent, cure, or alleviate symptoms of diseases. In this study, Omeprazole and Piperine are specifically evaluated. The development of a reliable analytical method for such drugs is critical for ensuring their correct dosage, effectiveness, and safety in pharmaceutical applications.

4) India:
India is the geographical context in which this research was conducted. The significance of the study arises from the country's growing pharmaceutical industry. Understanding local drug formulations and enhancing analytical methods like RP-HPLC can improve healthcare outcomes and regulatory practices within India’s diverse population and healthcare system.

5) Study (Studying):
The study represents a systematic investigation of a specific research question, in this case, the development and validation of an RP-HPLC method. It involves methodologies, experiments, and analyses that contribute to scientific knowledge, particularly within the realm of pharmaceutical sciences and drug quality assurance.

6) Noise:
In the context of chromatography, noise refers to the random fluctuations in the baseline signal that can interfere with the accuracy of detection. By establishing limits of detection and quantification, the study emphasizes the importance of minimizing noise for reliable quantitative analysis of Omeprazole and Piperine.

7) Performance:
Performance in this study relates to the efficiency and effectiveness of the developed HPLC method in analyzing Omeprazole and Piperine. Parameters like precision, linearity, and recovery rates assess the method's performance, indicating its reliability and usefulness in both laboratory and pharmaceutical settings.

8) Nalanda (Nalamda):
Nalanda refers to Nalanda College of Pharmacy, where the research was conducted. The institution plays a crucial role in pharmaceutical education and research in India. Its affiliation with Osmania University strengthens the relevance of the study, promoting academic collaboration and contributing to the pharmaceutical field.

9) Quality:
Quality in pharmaceutical research pertains to the accuracy, validity, and reliability of analytical methods. The study aims to develop a robust RP-HPLC method that ensures the quality of Omeprazole and Piperine formulations. High-quality standards are essential for safety and efficacy in drug development and manufacturing.

10) Andhra (Amdhra):
Andhra refers to Andhra Pradesh, the Indian state where the research was conducted. The regional context is important as it influences local pharmaceutical practices, regulations, and access to medicines. Understanding regional health needs can inform better drug formulation and analytical methodologies in the state.

11) Water:
Water, particularly double-distilled water, plays a vital role in laboratory experiments as a solvent and diluent. Its purity is essential for the reproducibility of results in the HPLC method. Using high-quality water minimizes contamination risks, ensuring accurate measurements during the drug analysis.

12) Pharmacological:
Pharmacological pertains to the study of drugs and their effects on biological systems. The paper discusses the pharmacological properties of Omeprazole and Piperine, focusing on their roles in enhancing drug bioavailability. Understanding pharmacological aspects is critical for researchers in pharmaceutical development and therapy.

13) Discussion:
The discussion section of a research study provides an interpretation of results, their implications, and how they compare to existing literature. It is where the authors articulate the significance of their findings, state limitations, and suggest future directions for research, making it crucial for advancing knowledge.

14) Narayana (Nara-ayana, Nara-yana):
Narayana refers to one of the co-authors of the study whose contributions add credibility to the work. The involvement of multiple researchers enhances the depth of expertise in the project. Each author’s expertise helps strengthen the findings and impacts the overall quality of the research.

15) Satya (Shatya):
Satya is likely another co-author, contributing to the research's collaborative nature. The diversity of authorship can lead to a well-rounded analysis of the research problem, enhancing the study’s validity and bridging various areas of expertise in pharmaceutical sciences.

16) Pur:
In the context of this study, 'poor' refers to the inadequate bioavailability of Omeprazole when exposed to gastric acid, creating a need for effective analytical methods. Addressing such challenges is crucial in pharmaceutical development to improve drug formulations and ensure patient safety and therapeutic success.

Other Science Concepts:

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

Resolution, Quality assurance, High performance liquid chromatography, Bioavailability enhancement, Retention time, Method development, Coefficient of Variation, Calibration curve, Analytical method validation, Precision, Linear Relationship, Chromatographic condition, Detection limit, Analytical grade reagent.

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