HPLC method for ketoprofen in bulk and gel with preservative.

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Journal name: World Journal of Pharmaceutical Research
Original article title: A validated stability–indicating hplc method estimation of ketoprofen in the presence of preservative in the bulk drug and formulated gel
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:

Pallavi P. Sadanshio, Sagar B Wankhede, Praveen D Chaudhari


World Journal of Pharmaceutical Research:

(An ISO 9001:2015 Certified International Journal)

Full text available for: A validated stability–indicating hplc method estimation of ketoprofen in the presence of preservative in the bulk drug and formulated gel

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

The research article presents a validated high-performance liquid chromatography (HPLC) method for the simultaneous analysis of Ketoprofen, Methyl paraben, and Propyl paraben in both bulk drug and formulated gel forms. Ketoprofen is a widely used non-steroidal anti-inflammatory drug (NSAID) known for its analgesic properties, while methyl and propyl paraben serve as preservatives in pharmaceutical formulations. The need for an efficient analytical method arises from the growing demand for precise quality control measures to ensure the stability and efficacy of drug formulations.

Development of the HPLC Method

The study focuses on developing a stability-indicating HPLC method that employs a C18 column and a methanol-water mobile phase at a 50:50 v/v ratio. The optimized conditions involved a flow rate of 1.0 ml/min and a detection wavelength of 233 nm. The retention times for Ketoprofen, Methyl paraben, and Propyl paraben were recorded at 4.95 min, 6.25 min, and 9.70 min, respectively. The method demonstrated excellent linearity across the respective concentration ranges for each component, with squared correlation coefficients exceeding 0.998. The precision of the method was confirmed by low relative standard deviation (RSD) values, indicating robustness and repeatability.

Stability and Forced Degradation Studies

Stability studies highlighted the importance of analyzing the samples under various stress conditions, such as acid and oxidative environments, following international guidelines. The drug demonstrated instability under acidic and oxidative conditions but remained stable in alkaline conditions. This aspect of the research underscores the importance of stability-indicating assays, which provide valuable insights into the expected shelf life and storage conditions of pharmaceutical products.

Validation and Robustness of the Method

The method underwent rigorous validation to ensure specificity, accuracy, and precision as per International Council for Harmonisation (ICH) guidelines. Results showed no interference from formulation excipients or degradation products during the quantitative analysis of the active ingredients. Recovery studies indicated that the method consistently achieved a recovery rate within the acceptable range of 98–102% for all three components, thus confirming its applicability in real-world quality control scenarios.

Conclusion

The findings of this research conclude that the developed HPLC method for the simultaneous determination of Ketoprofen, Methyl paraben, and Propyl paraben is efficient, precise, and cost-effective. The method not only meets the analytical demands of quality control laboratories but also possesses significant stability-indicating capability in the presence of degradation products. This innovative approach can serve as a viable alternative to existing methods, contributing to enhanced regulatory compliance and better management of pharmaceutical formulations. The successful implementation of such techniques is critical for ensuring product safety, efficacy, and reliability in the pharmaceutical industry.

FAQ section (important questions/answers):

What is the main purpose of the HPLC method developed in the study?

The HPLC method was developed for the simultaneous analysis of Ketoprofen, Methyl paraben, and Propyl paraben in bulk and formulated gel, ensuring accurate quantification in stability-indicating assays.

What were the detection wavelengths used in the HPLC method?

The HPLC method utilized a detection wavelength of 233 nm for Ketoprofen, Methyl paraben, and Propyl paraben to ensure optimal identification and quantification of the components in the samples.

What were the stability conditions tested in the study?

The drug stability was assessed under forced degradation conditions including hydrolysis, oxidation, photolysis, and thermal stress according to ICH guidelines, revealing specific instability in acidic and oxidative conditions.

What was the range of linearity for the compounds measured?

The linearity of the method was confirmed with concentration ranges: 5 to 25 μg/mL for Ketoprofen, 4 to 20 μg/mL for Methyl paraben, and 2.5 to 12.5 μg/mL for Propyl paraben.

How were the accuracy and precision of the method validated?

The method's accuracy was validated through recovery studies, showing a recovery rate of 98-102%. Precision was confirmed with intra-day and inter-day studies having RSDs below 2%, demonstrating the method's reliability.

What advantages does the developed HPLC method offer?

This HPLC method is simple, rapid, economical, and proven to be reliable, making it suitable for routine quality control in laboratories as well as for regulatory post-marketing surveillance programs.

Glossary definitions and references:

Scientific and Ayurvedic Glossary list for “HPLC method for ketoprofen in bulk and gel with preservative.”. 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:
A table in the context of this study refers to a systematically organized collection of data, which provides an easy reference for comparing results and statistics related to the tested compounds—Ketoprofen, Methyl paraben, and Propyl paraben. The tables often summarize key findings that support the research results, enhancing clarity and facilitating understanding of the significance of the research data.

2) Drug:
The term drug encompasses any chemical substance that, when introduced to a living organism, can cause a physiological change. In this study, Ketoprofen is a key drug investigated for its properties as a non-steroidal anti-inflammatory agent. Understanding its stability and interactions with preservatives is critical for assessing its effectiveness in pharmaceutical formulations.

3) Study (Studying):
Study refers to the comprehensive process of inquiry conducted to obtain new knowledge or validate existing knowledge regarding the stability of Ketoprofen and its preservatives. It involves systematic experimentation, measurement, and validation based on principles of scientific research, adhering to guidelines set by entities such as ICH to ensure the reliability of findings.

4) Quality:
Quality denotes the standard of a pharmaceutical product, which is determined by its efficacy, safety, and consistency. In this context, quality control measures for Ketoprofen gel formulations assess the concentration and stability of active substances, ensuring compliance with pharmacological standards, and guaranteeing that the product meets therapeutic expectations and regulatory requirements.

5) India:
India is the country where the research was conducted, reflecting its growing pharmaceutical industry and contributions to global healthcare solutions. The context chronicles the efforts of Indian universities and laboratories to innovate in drug formulation and quality assurance, making a significant impact on both local and international markets.

6) Maharashtra (Maharastra, Maha-rashtra):
Maharashtra is a state in India that serves as a hub for pharmaceutical research and development. The pharmaceutical institutions mentioned in the study, such as Padm. Dr. D.Y. Patil Institute, are based here, showcasing the state's pivotal role in advancing pharmaceutical technology and contributing significantly to ongoing research in drug stability and efficacy.

7) Water:
Water is used as a solvent in the formulation and analysis of the gel, playing a crucial role as it often forms the basis of mobile phases in liquid chromatography. Its purity and quality directly affect the outcomes of the chromatographic analyses, influencing the reliability of results when separating the components of interest.

8) Pune:
Pune is a major city in Maharashtra and a key educational and industrial center, especially for pharmaceutical sciences. The presence of multiple research institutions and laboratories in Pune signifies its importance in fostering pharmaceutical innovation and research, allowing collaboration among educators and scientists to advance drug development effectively.

9) Rheumatoid arthritis:
Rheumatoid arthritis is an autoimmune disease that is often treated with non-steroidal anti-inflammatory drugs like Ketoprofen. Its mention emphasizes the medical relevance of the study, underscoring how research on the stability of such drugs can lead to better treatment options for chronic inflammatory diseases affecting millions worldwide.

10) Performance:
Performance refers to how effectively the developed HPLC method measures and analyzes the concentrations of Ketoprofen and its preservatives. This aspect is vital for the validation of analytical procedures to ensure they meet regulatory standards while providing accurate and reproducible results for quality control in pharmaceutical practices.

11) Tamilnadu (Tamil-nadu):
Tamil Nadu is another state in India, highlighting the geographic diversity of the research locations mentioned in the study. The involvement of institutions from Tamil Nadu contributes to the collaborative effort within the Indian pharmaceutical sector to advance methodologies that ensure drug safety and efficacy in formulations.

12) Vallam:
Vallam is a locality in Tamil Nadu, specifically where Prist University, associated with the research, is located. Its inclusion emphasizes local education and research environments that promote advancements in pharmaceutical sciences, affecting drug formulation and stability research closely related to the study's objectives.

13) Nagapura (Naga-pura):
Nagpur is a city in Maharashtra, known for its academic contributions and is the location where reference standards for the study were procured. The mention of Nagpur underlines the collaborative nature of pharmaceutical research in India, involving multiple cities and institutions contributing to the field.

14) Tamil:
Tamil refers to the language and culture of the state Tamil Nadu. It symbolizes the local heritage and tradition of education in southern India, including the pharmaceutical research landscape. The region's linguistic and cultural identity is an integral part of the scholarly community engaged in drug development.

15) Nadu:
Nadu represents part of the name of Tamil Nadu and highlights the regional nomenclature in India. Its significance indicates the cultural and linguistic diversity within India, which influences academic disciplines, research methodologies, and collaborations across pharmaceutical and chemical research sectors in the area.

16) Post:
Post typically refers to the period following a specific occurrence or condition, influencing the development of regulations and standards in pharmacology. In the context of this study, it may relate to post-marketing surveillance which assesses long-term safety and efficacy of pharmaceutical products beyond initial approval for public use.

17) Discussion:
Discussion encapsulates the analytical portion of a paper, where results are interpreted and contextualized. It allows for evaluation of findings in relation to existing literature, enabling researchers to highlight implications of their studies on current practices in pharmaceutical development and potential areas for future research.

18) Substance:
Substance refers to the active ingredients being studied, notably Ketoprofen, Methyl paraben, and Propyl paraben. In pharmaceuticals, understanding the behavior and interaction of active substances is fundamental to developing effective formulations and ensuring safety and compliance with pharmaceutical regulations.

19) Resolving:
Resolving is an important term in chromatography that describes the method's ability to distinguish and separate different compounds in a mixture. High resolution in HPLC means clear separation of peaks, which is essential for accurate quantification of active ingredients and impurities in pharmaceutical products.

20) Thanjavur:
Thanjavur is a city in Tamil Nadu associated with the research institution involved in the study. Its mention indicates the reach of the study across different educational institutions, emphasizing the collaborative efforts within India's pharmaceutical research community and its geographical impact.

21) Activity:
Activity signifies the biological effect that a drug, such as Ketoprofen, has on the body. This concept is crucial in pharmaceutical research as it underlines the importance of investigating not just chemical stability but also therapeutic efficacy and safety of medicines leading to better treatment alternatives.

22) Relative:
Relative refers to comparing variables to assess their relationships, such as the concentrations of active ingredients concerning each other during testing. Such comparative studies are essential in pharmaceutical research to ensure consistency and reliability of formulations by maintaining appropriate proportions of drugs and excipients.

23) Heating:
Heating is a process that involves applying thermal energy and was used during the forced degradation studies to analyze the stability of Ketoprofen and its preservatives under stress conditions. Observing how compounds respond to heat helps to understand degradation mechanisms and improve product formulation.

24) Disease:
Disease encompasses medical conditions that may require pharmacological intervention, such as arthritis, where Ketoprofen is utilized for treatment. The study enhances understanding of how effective pharmaceutical formulations can manage such diseases, making research into drug stability and quality critical for patient care.

25) Science (Scientific):
Science represents the systematic approach to knowledge that drives research in pharmaceuticals, integrating methodologies to test hypotheses, analyze data, and derive conclusions. The rigorous scientific principles applied in this study ensure reliable results that can contribute to advancements in drug formulation and quality assurance.

26) Purity:
Purity is a measure of the absence of contaminants in a substance. In pharmaceuticals, ensuring the purity of active ingredients is vital for achieving consistent therapeutic efficacy and safety. Assessments of stability and the effects of preservatives directly relate to the purity of the formulated drugs.

27) Powder:
Powder denotes the physical form in which pharmaceutical compounds, including drug ingredients and excipients, are often processed and formulated. In developing gel products, the behavior of powdered drug ingredients under various conditions affects the formulation's stability and purity, crucial for therapeutic effectiveness.

28) Sagar (Sagár):
Sagar is a given name, possibly referring to Sagar B. Wankhede, one of the co-authors involved in the study. Collaboration among researchers signifies the collective effort in advancing scientific knowledge and methodologies within pharmaceutical research, highlighting teamwork in drug development and validation processes.

29) Patil:
Patil is a surname that might refer to Dr. D. Y. Patil Institute, a key contributor to the pharmaceutical study. The naming emphasizes the role of academic institutions and their contributions to research, education and quality assurance in the pharmaceutical sector, fostering scientific innovation.

30) Lamp:
Lamp refers to the light source (typically a D2 lamp) used in UV detection, a critical component in HPLC systems. The proper functioning of the lamp is essential to maintain accurate detection of analytes, highlighting the technical aspects of chromatography that play a role in method validation.

Other Science Concepts:

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Discover the significance of concepts within the article: ‘HPLC method for ketoprofen in bulk and gel with preservative.’. Further sources in the context of Science might help you critically compare this page with similair documents:

Accuracy, Quality Control, High performance liquid chromatography, Sample analysis, Quality control laboratories, Pharmaceutical analysis, Chromatographic separation, Whatman filter paper, Limit of detection, Limit of quantification, HPLC Method, Cost-effective method, Pharmaceutical Research, Analytical Procedure, Statistical validation, Specificity, Recovery studies, Method validation, Quality control purpose, Relative standard deviation, Standard calibration curve, Routine Analysis, Chromatographic condition, Environmental samples.

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