UPLC-DAD for sensitive quantitation of haloperidol in plasma.
Journal name: World Journal of Pharmaceutical Research
Original article title: Fast and sensitive validated method for quantitation of haloperidol in human plasma using ultra performance liquid chromatography (uplc) with diode array detection
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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M. Siva Selva Kumar and M. Ramanathan
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Full text available for: Fast and sensitive validated method for quantitation of haloperidol in human plasma using ultra performance liquid chromatography (uplc) with diode array detection
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
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Summary of article contents:
Introduction
This study presents a validated ultra-performance liquid chromatography (UPLC) method for the quantification of haloperidol (HAL) in human plasma. HAL is an antipsychotic medication widely used in the treatment of psychosis, particularly schizophrenia. Given the drug's low concentration in biological samples, sensitive and specific analytical methods are essential for effective therapeutic drug monitoring. Traditional analytical techniques such as high-performance liquid chromatography (HPLC) often have disadvantages, including high costs and lengthy sample processing times; thus, the development of an efficient UPLC method is highly relevant.
Method Development
The UPLC method developed for the detection of HAL utilizes a simple liquid-liquid extraction technique for sample preparation, employing an Acquity UPLC BEH C18 column at a temperature of 35ºC. The mobile phase consists of a 12 mM ammonium acetate buffer at pH 3.5 with acetic acid and acetonitrile, flowing at 0.4 mL/min. The method allows for a total run time of only 2.5 minutes. The detection is achieved with a photodiode array detector set to 240 nm, allowing for the rapid and effective separation of HAL and an internal standard (clozapine) within the plasma samples.
Method Validation
Validation of the UPLC method adhered to FDA guidelines, assessing various parameters including specificity, accuracy, precision, recovery, and stability. Specificity was confirmed with no interference from endogenous compounds in blank plasma samples. The method demonstrated excellent linearity within a concentration range of 1 to 100 ng/mL, with a regression coefficient greater than 0.991. Intra- and inter-day precision and accuracy were found to be within acceptable limits, with recoveries of HAL from plasma showing promising results. Moreover, the stability assessments indicated that HAL remained stable under various storage and handling conditions, further validating the reliability of the method.
Advantages Over Traditional Methods
The UPLC-DAD method provides several advantages compared to traditional HPLC and LC-MS/MS techniques. It offers a shorter chromatographic run time, leading to more efficient processing of samples. The methodology also enables a higher recovery rate of the analyte, yielding sharper peaks for improved quantification. Notably, the sensitivity achieved with the UPLC method is comparable to that of LC-MS/MS while being significantly more cost-effective, making it a viable alternative for routine therapeutic drug monitoring and clinical toxicology studies.
Conclusion
In conclusion, the UPLC-DAD method developed for the quantification of haloperidol in human plasma has demonstrated reliability and efficiency, making it suitable for therapeutic drug monitoring and clinical applications. Its rapid processing time, significant sensitivity, and ease of use, along with its validation against established guidelines, highlight its potential to replace more complex and expensive analytical methods. This innovative approach to measuring HAL in biological samples represents a valuable advancement in the field of pharmaceutical analysis.
FAQ section (important questions/answers):
What is the primary objective of the study on haloperidol?
The study aims to establish a simple, sensitive, and accurate UPLC method for detecting and quantifying haloperidol in human plasma, with potential applications in therapeutic drug monitoring and clinical toxicological studies.
What extraction method was used for haloperidol in plasma?
A simple liquid-liquid extraction method was used to extract haloperidol from human plasma. The process involved vortex mixing and centrifugation, followed by evaporation of the organic layer and reconstitution in the mobile phase for analysis.
What range of concentrations was used for the calibration curve?
The calibration curve for haloperidol was plotted across a concentration range of 1 to 100 ng/mL in human plasma, demonstrating excellent linearity with a regression coefficient greater than 0.991.
How was the specificity of the assay determined?
Specificity was assessed by analyzing six replicates of blank plasma from different donors, ensuring no interfering peaks appeared at the retention times of haloperidol or the internal standard.
What were the findings regarding the stability of haloperidol?
Haloperidol demonstrated stability under various conditions, including bench-top stability at room temperature for 8 hours and long-term storage at -80ºC for 30 days, with measurements remaining within ±15% of nominal concentrations.
What advantages does the UPLC-DAD method offer over other techniques?
The UPLC-DAD method provides advantages such as shorter chromatographic run times, higher extraction recovery, and cost-effectiveness, while offering sensitivity similar to that of LC-MS/MS methods.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “UPLC-DAD for sensitive quantitation of haloperidol in plasma.”. 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:
The term 'Drug' is central to the research presented, as the study focuses on haloperidol, an antipsychotic medication used to manage psychotic symptoms in patients. Understanding the pharmacokinetics and dynamics of drugs like haloperidol is vital for therapeutic monitoring, formulation, and ensuring patient compliance in psychiatric treatments.
2) Kumar:
Kumar refers to M. Siva Selva Kumar, one of the authors of the study. His expertise in pharmaceutical analysis underpins the research methodology and impact of the presented work. His contributions highlight the importance of academia in developing analytical methods to improve clinical practices in pharmacology.
3) India:
India is the geographical context of the research, indicating the location where the study was conducted. The country's diverse healthcare needs and pharmaceutical industry present unique challenges and opportunities, underlining the relevance of developing efficient analytical methods like UPLC for drug monitoring in clinical settings within India.
4) Water:
Water is a crucial component in chromatography and sample preparation. It is used in the aqueous buffer solutions and as a diluent for stock solutions. The purity of water, as well as its role as a solvent in reactions, affects the reliability and accuracy of quantitative analysis in pharmacological studies.
5) Performance:
Performance in this context refers to the effectiveness and efficiency of the developed UPLC method. This includes aspects like sensitivity, specificity, and speed of analysis, demonstrating that a high-performing method can significantly enhance drug quantitation in clinical and therapeutic settings, improving patient monitoring and care.
6) Table:
Tables in the research context provide organized data summaries, such as measurement results and validation metrics. They facilitate easy comparison and interpretation of results, including precision and accuracy metrics for haloperidol quantification in plasma, which is essential for validating the effectiveness of the UPLC method.
7) Tamilnadu (Tamil-nadu):
Tamilnadu is the state in India where the research was conducted, specifically at PSG College of Pharmacy in Coimbatore. The local academic and healthcare environment provides a backdrop for addressing regional pharmacological needs and testing methods that could enhance drug monitoring and clinical practices within the state.
8) Study (Studying):
The term 'Study' denotes a systematic investigation aimed at developing and validating a UPLC method for measuring haloperidol in plasma. It encompasses both experimental techniques and analysis, contributing to the broader field of pharmaceutical sciences and aiding in improved clinical monitoring practices for psychiatric patients.
9) Pharmacology:
Pharmacology is the study of how drugs interact with biological systems. It forms the scientific foundation for the research being presented, focusing on how haloperidol functions as an antipsychotic agent. Accurate measurement methods in pharmacology are essential for understanding drug effects, optimizing treatment regimens, and ensuring patient safety.
10) Measurement:
Measurement in this study refers to the quantification of haloperidol concentrations in plasma using the UPLC method. Accurate measurements are critical for ensuring effective therapeutic drug monitoring, allowing healthcare professionals to adjust dosages based on plasma levels, which enhances treatment outcomes and patient safety.
11) Discussion:
Discussion serves as an analytical section where findings are interpreted and contextualized within the existing body of knowledge. This part of the research offers insights into the method's implications for clinical practice, comparing it to other analytical methods and emphasizing its relevance in therapeutic monitoring.
12) Psychosis:
Psychosis refers to conditions where an individual experiences delusions or hallucinations. The study is directly relevant to psychotic disorders as it focuses on haloperidol, a medication commonly used to treat such conditions. Effective monitoring of drug levels can lead to improved management of these serious mental health issues.
13) Quality:
Quality pertains to the reliability and accuracy of the developed UPLC method for measuring haloperidol in plasma. High-quality analytical methods ensure precise dosing and effective patient monitoring, ultimately contributing to better clinical outcomes and minimizing the risk of side effects or treatment failures.
14) Blood:
Blood plays a vital role as the medium from which plasma samples are derived for drug quantification. In pharmacology, analyzing blood plasma levels of drugs like haloperidol provides crucial information on therapeutic efficacy, safety, and patient compliance, reinforcing the need for accurate blood-based measurement techniques.
15) Shiva (Siva):
Siva refers to M. Siva Selva Kumar, signifying his role as a lead researcher in the study. His expertise contributes to advancing analytical techniques in pharmacology, emphasizing the importance of qualified researchers in developing methodologies that enhance drug monitoring and therapeutic practices in medicine.
16) Food:
Food regulations and guidelines influence the integrity of pharmaceutical testing, particularly in the context of bioanalytical methods for drugs in plasma. Ensuring that bioanalytical methods adhere to quality standards, often outlined by food and drug regulatory authorities, is crucial for validating the safety and efficacy of drugs.
17) Pur:
Poor compliance in patients can significantly affect treatment outcomes, particularly in chronic conditions like mental illness. The study addresses this issue by developing a method to effectively monitor plasma levels of haloperidol, aiding healthcare professionals in identifying and managing cases of non-compliance more effectively.
Other Science Concepts:
Discover the significance of concepts within the article: ‘UPLC-DAD for sensitive quantitation of haloperidol in plasma.’. Further sources in the context of Science might help you critically compare this page with similair documents:
Quality control standards, Mobile phase, Chromatographic separation, Calibration curve, Method validation, FDA guidelines, Linear regression analysis, Specificity of the method, Inter-day precision, Ultra performance liquid chromatography, Acceptance criteria, Therapeutic drug monitoring, Stability assessment, Photodiode array detector, Liquid-liquid extraction technique, Chromatographic run time.