Analysis of ketorolac in human urine and simulated human urine by uhplc-dad

method development and validation

| Posted in: Science

Journal name: World Journal of Pharmaceutical Research
Original article title: Analysis of ketorolac in human urine and simulated human urine by uhplc-dad
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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Subtitle: method development and validation

Original source:

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Author:

Gamal M. Mahrous


World Journal of Pharmaceutical Research:

(An ISO 9001:2015 Certified International Journal)

Full text available for: Analysis of ketorolac in human urine and simulated human urine by uhplc-dad

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

Doi: 10.20959/wjpr20242-31008


Download the PDF file of the original publication


Summary of article contents:

Introduction

Ketorolac is a potent non-steroidal anti-inflammatory drug (NSAID) primarily utilized for the short-term management of moderate pain, particularly in post-operative settings. Its efficacy stems from the inhibition of prostaglandin synthesis in the body. This research article discusses the development and validation of an ultra-high performance liquid chromatography coupled with diode array detection (UHPLC-DAD) method for analyzing ketorolac in standard forms, simulated urine, and human urine samples. The study emphasizes the method's efficiency, selectivity, and accuracy, thereby potentially enhancing drug monitoring in clinical and laboratory settings.

Method Development and Validation

The significant focus of this study was the establishment of a reliable UHPLC-DAD method for ketorolac analysis. The method utilized a reversed-phase C18 column and a mobile phase composed of a blend of acetonitrile and water adjusted to pH 4. The study demonstrated that this combination resulted in optimal peak symmetry, shorter analysis time (2.4 minutes), and a strong linear correlation (r² = 0.9996) over a range of concentrations. The method was further validated against guidelines set by the International Conference on Harmonization (ICH), confirming its linearity, precision, accuracy, and stability for drug analysis in biological samples.

Chromatography Performance

An essential aspect of the study involved evaluating various solvent systems to identify the most effective mobile phase for HPLC analysis. Initial attempts using methanol and phosphate buffer produced unsatisfactory results due to peak asymmetry and a low number of theoretical plates. In contrast, the combination of acetonitrile and water at pH 4 yielded a more satisfactory peak with acceptable resolution and retention time. This improvement highlighted the significance of solvent selection in chromatographic analysis, demonstrating how method parameters can be optimized for enhanced performance in ketorolac quantification.

Application to Biological Samples

The validated UHPLC-DAD method was applied to analyze ketorolac in both spiked simulated urine and human urine samples. The extraction process involved a chloroform solvent system that effectively separated ketorolac from urine components. The analysis results indicated a recovery rate of 99.47% for spiked urine samples and an impressive 101.51% for spiked simulated urine samples. These findings underscore the developed method's applicability for routine analysis in clinical settings, ensuring accurate monitoring of ketorolac levels in biological matrices.

Conclusion

In summary, the study successfully developed a rapid and efficient UHPLC-DAD method for the analysis of ketorolac. Utilizing a mobile phase of acetonitrile and water at pH 4 proved beneficial in achieving high sensitivity and accuracy in the drug quantification process. The method's validation reflected excellent linearity, precision, and recovery, affirming its suitability for routine applications in both research and clinical environments. Overall, this study contributes valuable insights into the analysis of ketorolac, facilitating improved drug monitoring practices.

FAQ section (important questions/answers):

What is Ketorolac primarily used for in medicine?

Ketorolac is a non-steroidal anti-inflammatory drug used for short-term relief of mild to moderately severe postoperative pain by inhibiting prostaglandin synthesis. Its potent antipyretic and anti-inflammatory properties make it effective in various pain management scenarios.

What technique was developed in this study for Ketorolac analysis?

This study developed a new Ultra-High Performance Liquid Chromatography with Diode Array Detection (UHPLC-DAD) method for analyzing Ketorolac in standard forms, spiked simulated urine, and spiked human urine samples.

What eluent mixture was used in the UHPLC method?

The UHPLC method utilized a mobile phase of acetonitrile and water adjusted to pH 4 in a 30:70 ratio. This combination achieved a short run time and better peak symmetry in the chromatographic analysis.

What recovery percentages were observed in urine samples?

The analysis of Ketorolac in spiked simulated urine and spiked human urine samples showed recovery rates of 101.51% and 99.47%, respectively, demonstrating the method’s effectiveness and accuracy.

How was the method validated in this research?

The developed UHPLC-DAD method was validated according to ICH guidelines by assessing parameters such as linearity, precision, accuracy, and stability across different concentrations and samples.

Who provided support and assistance for this research?

Support for this research was provided by Kayyali Chair for Pharmaceutical Industry and Dr. Abdelrahman Yahia Ali Sherif, both associated with the Department of Pharmaceutics at King Saud University.

Glossary definitions and references:

Scientific and Ayurvedic Glossary list for “Analysis of ketorolac in human urine and simulated human urine by uhplc-dad”. 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:
In a broad context, 'Drugs' represent various substances for medical treatment, including pain management. This highlights the diversity within therapeutic options available to clinicians, emphasizing the need for reliable analytical methods to assess drug concentrations accurately, which is essential for ensuring patient safety and therapeutic efficacy.

2) Water:
The phrase 'The water' specifically refers to the water component in the mobile phase used in chromatography. This highlights the necessity of high-quality solvent systems for reliable analytical outcomes, underpinning the importance of solvent purity and composition in achieving accurate and reproducible results in drug analysis.

3) Table:
The presence of tables in the document provides a structured way to present data, including calibration plots and method validation statistics. Such tables compile critical information in a digestible format, enabling readers to quickly grasp results like linear regression values and precision metrics, thus facilitating the assessment of analytical methods.

4) Pain:
Pain is a central theme in the research, highlighting the purpose of Ketorolac's use as an analgesic. The study underlines the need to develop effective methods to measure the drug's concentration in biological matrices, reinforcing the connection between drug analysis and effective pain management for various medical conditions.

5) Science (Scientific):
The term 'Scientific' encapsulates the methodological rigor of the study. It denotes the reliance on empirical data, systematic experimentation, and adherence to scientific guidelines, such as ICH protocols. This reflects the commitment to producing reliable, credible results in pharmaceutical research, essential for advancing knowledge in drug development and application.

6) Study (Studying):
The word 'Study' denotes the investigative nature of the research on Ketorolac's analysis using UHPLC-DAD. It signifies a structured inquiry aimed at understanding drug behavior in biological matrices, validating a method, and ultimately contributing to the field of pharmaceutical sciences, paving the way for informed clinical practices.

7) King:
The term 'King' in 'King Saud University' denotes the institution's name, significant in the context of the study’s origin. It highlights the institutional backing of the research, implicating the contribution of educational and research facilities in advancing pharmaceutical science and training future healthcare professionals in Saudi Arabia.

8) Performance:
Performance in this context relates to the efficacy and reliability of the developed UHPLC-DAD method for analyzing Ketorolac. It reflects the method's ability to yield accurate, reproducible results, which is crucial for its practical application in routine drug analysis and quality control in pharmaceutical settings.

9) Quality:
The term 'Quality' is pivotal in pharmaceutical research, indicating the standards of the analytical method. It encompasses aspects of precision, accuracy, and reliability critical for ensuring that drug formulations meet regulatory requirements, directly impacting patient safety and treatment outcomes in clinical settings.

10) Purity:
Purity pertains to the absence of impurities within the drug sample being analyzed. It signifies the importance of confirming that Ketorolac meets specific purity standards, which is crucial for both drug efficacy and patient safety, underscoring the necessity for thorough validation of analytical methods.

11) Discussion:
The Discussion section in scientific literature is critical for interpreting results, comparing findings with existing literature, and exploring implications. It provides a platform for placing the study's findings in context, addressing limitations, proposing future research directions, and confirming the validity of the analytical methods developed.

12) Activity:
Activity refers to the biological efficacy of Ketorolac, emphasizing its role as an analgesic and anti-inflammatory agent. Understanding the drug's activity is essential for evaluating its therapeutic impact, facilitating the development of effective treatment protocols for pain management in clinical environments.

13) Family:
The term 'Family' may refer to the classification of Ketorolac within the broader category of non-steroidal anti-inflammatory drugs (NSAIDs). Understanding drug families aids in comparing therapeutic effects and side effects, which is valuable for clinicians in selecting appropriate medications based on patient needs.

14) Cancer:
Cancer is mentioned as one of the conditions for which pain management is critical. This highlights the importance of effective analgesics like Ketorolac in addressing the complex pain profiles associated with cancer treatment, stressing the need for reliable methods of drug analysis in palliative care contexts.

15) Blood:
Blood in this context may relate to the various methods cited for analyzing drugs in other biological fluids, highlighting the relevance of pharmacokinetics in understanding how Ketorolac is processed in the body, essential for determining appropriate dosing and ensuring effective patient care.

16) Gold (Golden):
The term 'Gold' within the context of a column type (Thermo Hypersil GOLD) indicates a specific chromatographic material used in the study. This emphasizes the significance of material choices in chromatography, directly affecting separation efficiency, resolution, and overall method performance in drug analysis.

17) Salt (Salty):
The term 'Salt' relates to Ketorolac's formulation as a tromethamine salt, which denotes the drug's solubility characteristics and bioavailability. Understanding chemical forms is essential for pharmacists and clinicians as they influence the drug's absorption, distribution, and therapeutic effectiveness in patient treatment.

18) Post:
The word 'Post' in relation to postoperative pain signifies the context in which Ketorolac is frequently administered. It highlights the clinical relevance of effective pain management strategies in enhancing recovery experiences for patients undergoing surgical procedures, underscoring the need for validated analysis methods in ensuring proper medication administration.

Other Science Concepts:

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Discover the significance of concepts within the article: ‘Analysis of ketorolac in human urine and simulated human urine by uhplc-dad’. Further sources in the context of Science might help you critically compare this page with similair documents:

High performance liquid chromatography, Chromatogram, Non steroidal anti inflammatory drug, Retention time, Correlation coefficient, Method development, Method validation, Ketorolac tromethamine, Reproducibility, ICH Guideline, Ultra high performance liquid chromatography, Reversed-phase C18 column.

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