HPLC method for simultaneous miconazole and ornidazole estimation.

| Posted in: Science

Journal name: World Journal of Pharmaceutical Research
Original article title: Stability indicating chrometographic method development and validation for the simultaneous estimation of miconazole and ornidazole in its pharmaceutical dosage form by 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:

Gameti Nilam Ramanlal and Darpini Patel


World Journal of Pharmaceutical Research:

(An ISO 9001:2015 Certified International Journal)

Full text available for: Stability indicating chrometographic method development and validation for the simultaneous estimation of miconazole and ornidazole in its pharmaceutical dosage form by hplc

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

Doi: 10.20959/wjpr201717-10418

Copyright (license): WJPR: All rights reserved


Download the PDF file of the original publication


Summary of article contents:

Introduction

The study focuses on the development and validation of a stability-indicating chromatographic method using High-Performance Liquid Chromatography (HPLC) for the simultaneous estimation of two medicinal compounds, Miconazole and Ornidazole, in their pharmaceutical dosage forms. Miconazole is primarily used as an antifungal agent, while Ornidazole serves to treat protozoan infections. The method developed is characterized as accurate, precise, and simple, making it suitable for routine quality control in pharmaceutical settings.

Method Development and Validation

The chromatographic method utilized a C18 reversed-phase column with a mobile phase composed of water, acetonitrile, and acetic acid in a specific ratio. An injection volume of 20 μL was evaluated at a flow rate of 1 ml/min and detected at a wavelength of 224 nm. The method demonstrated linearity for both Miconazole and Ornidazole, with correlation coefficients of 0.999. The limits of detection were found to be 0.089 μg/ml for Miconazole and 0.457 μg/ml for Ornidazole, establishing a foundation for accurate quantification in various formulations.

Stability Studies and Forced Degradation

Stability studies were conducted following ICH guidelines, which included assessments of acid, base, oxidative, thermal, and photodegradation. Each degradation study was meticulously designed to ascertain the stability of the active pharmaceutical ingredients under different stress conditions. The results revealed that both Miconazole and Ornidazole retained a significant degree of their integrity, with specific degradation percentages documented under each condition. This underscores the robustness of the developed HPLC method in analyzing the stability of these compounds.

Specificity and Robustness of the Method

The validation of the HPLC method included specificity assessments to ensure no interferences were present from blank samples. The results confirmed the lack of significant interference, validating the specificity of the method for simultaneous estimation of both drugs. Furthermore, robustness testing involved slight alterations to the flow rate, pH, and mobile phase composition, demonstrating that the method maintained its integrity under varying conditions, with relative standard deviations within acceptable limits.

Conclusion

The developed RP-HPLC method for the simultaneous estimation of Miconazole and Ornidazole is affirmed to be precise, accurate, and reliable for routine analysis in pharmaceutical formulations. The research highlights the importance of stability studies, validation parameters, and the method's capability to withstand various analytical challenges. With its successful implementation, this chromatographic technique can facilitate enhanced quality assurance processes within the pharmaceutical industry, ensuring that formulations meet prescribed standards of efficacy and safety.

FAQ section (important questions/answers):

What is the purpose of the developed HPLC method?

The developed HPLC method is designed for the simultaneous estimation of Miconazole and Ornidazole in pharmaceutical dosage forms, ensuring accuracy, precision, and rapid analysis.

What mobile phase was used for the HPLC method?

The mobile phase used in the HPLC method was a mixture of Water, Acetonitrile, and Acetic acid in a ratio of 30:70:0.1, which optimized separation and resolution.

What are the limits of detection for the drugs?

The limits of detection for Miconazole and Ornidazole were found to be 0.089 µg/ml and 0.457 µg/ml, respectively, showcasing the method's sensitivity.

How was the precision of the HPLC method validated?

The precision was validated through repeatability, intraday, and interday testing, with relative standard deviation (RSD) values confirming the method's reliability.

What forced degradation studies were conducted?

Forced degradation studies included acid, base, oxidative, thermal, and photo degradation to assess the stability of Miconazole and Ornidazole under various conditions.

What were the recovery rates for the drugs during validation?

The recovery rates for Miconazole and Ornidazole ranged between 100.365% and 101.458%, indicating the accuracy of the developed HPLC method in quantifying the drugs.

Glossary definitions and references:

Scientific and Ayurvedic Glossary list for “HPLC method for simultaneous miconazole and ornidazole estimation.”. 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) Water:
Water is crucial in pharmaceutical research and HPLC analysis. It serves as a solvent in preparing mobile phases and standard solutions, impacting the solubility and stability of drugs. In the study, water is combined with acetonitrile and acetic acid as part of the mobile phase, indicating its importance in the chromatographic separation process.

2) Table:
Tables are used in research for presenting data concisely, allowing for quick reference and analysis. For instance, in the study, tables summarize experimental results, including solubility, degradation percentages, and drug concentrations. They enhance clarity and assist in comparing findings systematically, streamlining the interpretation of complex information.

3) Drug:
Drugs such as Miconazole and Ornidazole are the primary focus of the research. Understanding their chemical properties, efficacy, and stability is essential in pharmaceutical applications. The study develops and validates an HPLC method for their simultaneous estimation, highlighting the importance of accurate drug measurements in dosage forms for therapeutic use.

4) Powder:
The term powder in this context refers to the physical state of the drugs during analysis. Both Miconazole and Ornidazole are prepared in powdered form for various experimental procedures, including solubility tests and degradation studies. Working with powdered drugs facilitates uniformity and correct dosing in analytical experiments.

5) Dish (Dis):
A dish is often used in laboratory settings for preparing and exposing pharmaceutical compounds during experiments, such as thermal and photodegradation studies. In the research, powders of Miconazole and Ornidazole are kept in dishes for controlled exposure to temperature and light, ensuring precise conditions for studying drug stability.

6) Study (Studying):
The entire process described in the text refers to a study aimed at developing and validating a stability indicating HPLC method. This study encompasses the methodology, analysis, and results, contributing significantly to the field of pharmaceutical sciences. It highlights the systematic approach needed for effective drug evaluation.

7) Quality:
Quality is a critical concept in pharmaceuticals, referring to the consistency, safety, and efficacy of drugs. The research emphasizes method validation parameters like precision, accuracy, and robustness, ensuring that the developed HPLC methods meet high-quality standards for routine analysis in pharmaceutical formulations.

8) Patel:
Patel refers to Darpini Patel, a co-author and associate professor involved in guiding and supervising the research work. Her expertise is essential for ensuring methodological rigor and academic integrity in the study. The acknowledgment of her contributions reflects collaborative efforts in scientific endeavors within academic settings.

9) Measurement:
Measurement is a fundamental aspect of pharmacological research, encompassing various quantitative techniques to ascertain drug concentrations. The study includes precise calculations of areas under peaks in chromatograms, crucial for determining the amount of active ingredients in formulations, contributing to accurate dosing and quality control.

10) Disease:
Diseases such as those treated by Ornidazole, often linked to protozoal infections, are central to the rationale behind drug research. Understanding disease mechanisms drives the development of effective treatments, motivating studies like the one on drug stability. The role of drugs in combating diseases underpins their significance in healthcare.

11) Raval:
Raval pertains to K.B. Raval College of Pharmacy, the institution where the study was conducted. This affiliation underscores the academic and research environment that fosters pharmaceutical innovation. The college's resources and faculty expertise facilitate research endeavors, contributing to advancements in pharmaceutical sciences through student and faculty collaboration.

12) Nilam:
Nilam refers to Gameti Nilam Ramanlal, the primary researcher and author of the study. Her contributions are pivotal in developing the HPLC method and validating its effectiveness. Acknowledging her role highlights the importance of individual researchers in advancing scientific knowledge and supporting collaborative research efforts in academia.

13) Calculation:
Calculation is essential for processing data obtained from experiments, such as determining concentration levels and evaluating method performance metrics. The study involves various calculations, including limits of detection and quantification. Accurate calculations are critical in ensuring reliable results, which can impact therapeutic decisions in clinical settings.

14) Discussion:
Discussion serves as a section in research articles where findings are interpreted in the context of existing literature. In this study, the discussion likely addresses the implications of the HPLC method results, comparing them with prior studies, and elaborating on the significance of the findings for pharmaceutical analysis.

15) Narendra (Nara-indra):
Narendra is mentioned as a family member of the author, Gameti Nilam Ramanlal. Personal acknowledgments reflect the supportive network that contributes to researchers’ success. Emphasizing the role of family in academic achievements highlights the often-overlooked personal sacrifices and encouragement that facilitate scholarly pursuits.

16) Teaching:
Teaching pertains to the educational aspect of pharmacy and research, focusing on imparting knowledge and skills. The study, supervised by academic professionals, contributes to the teaching framework by providing empirical data that can be used for instructive purposes, enhancing the learning experience for students in pharmacy programs.

17) Relative:
Relative may refer to the relative measurements and comparisons calculated throughout the research, such as relative standard deviation (RSD). These statistical measures provide insights into data consistency and variability, illustrating the reliability of the methods employed and their applicability in quality control within pharmaceutical sciences.

18) Sheetal:
Sheetal is recognized as a supportive individual in the research project. The acknowledgment of friends and colleagues emphasizes the collaborative nature of research work in academia, illustrating how teamwork and mutual support are vital components in overcoming challenges and achieving research objectives.

19) Pankti (Pamkti):
Pankti, similar to Sheetal, is acknowledged for her support in the research project. Recognizing the contributions of friends highlights the collaborative spirit within academic environments, fostering a sense of community among researchers. Such acknowledgments reinforce the importance of peer relationships in achieving scientific success.

20) Family:
Family represents the foundational support system that accompanies an individual's journey through academic and professional challenges. In research, family can influence a researcher's motivation, perseverance, and overall well-being, fostering an environment conducive to intellectual growth, as seen in the acknowledgements section.

21) Vidhi:
Vidhi is mentioned as another individual who contributed support in the research process. Acknowledging peers reinforces the collaborative efforts inherent in research projects. Their collective contributions may include brainstorming, data analysis, and emotional support, all of which are essential for a successful research experience.

22) Jaya:
Jaya’s mention in the acknowledgments reflects the importance of teamwork in research settings. Support from colleagues can help navigate the complexities of scientific work. Recognizing contributions from various individuals highlights the collaborative nature of academia and the significance of networking in professional growth.

23) Arya:
Arya is acknowledged as the author's child, signifying the personal sacrifices and time management required when balancing research with family life. This inclusion highlights the often-overlooked challenges faced by researchers, particularly those who are managing familial responsibilities alongside academic or professional pursuits.

24) Line:
Line could refer to the regression lines used in analytical data modeling, crucial in determining linear relationships in data analysis. In this context, the line represents the mathematical relationships established during the study, essential for assessing the accuracy and reliability of the quantitative measurements obtained through HPLC.

25) Life:
Life encompasses the personal and professional journey of researchers, highlighting the interconnectedness of their academic pursuits with their experiences outside of the lab. It includes challenges, support systems, and motivations that shape their work and contributions to the scientific community, enriching the discourse in pharmaceutical research.

Other Science Concepts:

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Discover the significance of concepts within the article: ‘HPLC method for simultaneous miconazole and ornidazole estimation.’. Further sources in the context of Science might help you critically compare this page with similair documents:

Accuracy, Chromatogram, Retention time, Mobile phase, Limit of detection, Limit of quantification, Method development, Sample preparation, Pharmaceutical dosage form, Precision, Chromatographic condition.

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