A review on lc-ms/ms in bioanalytical studies
Journal name: World Journal of Pharmaceutical Research
Original article title: A review on lc-ms/ms in bioanalytical studies
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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Maheswari .G, Shantha kumari .K, Abdul Rahaman .S, Revathi .S, Neeharika .M
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Full text available for: A review on lc-ms/ms in bioanalytical studies
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
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Summary of article contents:
Introduction
The article from the World Journal of Pharmaceutical Research discusses the significance of liquid chromatography-mass spectrometry (LC-MS), emphasizing its role in bioanalytical studies due to its high sensitivity, accuracy, and ability to analyze a wide range of biological molecules. The review outlines the importance of bioanalytical method development and validation in drug discovery and development.
Bioanalytical Method Development
Bioanalytical method development is crucial for the quantitative determination of drugs and their metabolites in biological fluids. LC-MS is preferred for its high sensitivity and specificity. The method development involves several steps, including considering the physicochemical properties of the analyte, determining its solubility, optimizing MS/MS conditions, and developing the liquid chromatography (LC) method. Sample preparation is a critical step, employing techniques like solid-phase extraction (SPE), liquid-liquid extraction (LLE), and protein precipitation to obtain homogenous solutions suitable for reliable MS detection.
Method Validation
Bioanalytical method validation ensures that the method is reliable and reproducible for its intended application. It involves validating parameters such as selectivity, sensitivity, accuracy, precision, recovery, stability, and ruggedness. Full, partial, and cross-validation are different types, with full validation necessary when developing a bioanalytical method for the first time. Validation parameters are evaluated based on guidelines published by regulatory agencies like the USFDA.
Stability Testing
Stability testing evaluates the stability of analytes during sample handling, storage, and the analytical process. It includes testing the stability of stock solutions, working solutions, and analytes in biological matrices under various conditions such as freeze-thaw cycles, bench-top stability, and long-term storage. The stability of the analyte and internal standard is assessed to ensure that the analytical method remains reliable over the course of the study.
Conclusion
LC-MS, especially when combined with tandem MS, is a valuable analytical tool in bioanalysis due to its high sensitivity and specificity. The development of robust bioanalytical methods, proper sample preparation, and thorough validation are essential for ensuring accurate and reproducible results. LC-MS/MS is particularly beneficial for clinical laboratories, offering high-throughput and precise quantification of analytes. The review emphasizes that quality in method development, sample preparation, and understanding of the instrumentation all contribute significantly to a high-quality analytical method.
FAQ section (important questions/answers):
What is LC-MS/MS?
LC-MS/MS refers to Liquid Chromatography-Mass Spectrometry/Mass Spectrometry, a technique that combines liquid chromatography separation with mass spectrometry for the analysis of complex biological samples.
Why is method validation important in bioanalysis?
Method validation ensures the bioanalytical method is accurate, precise, and suitable for its intended purpose, helping to reliably quantify drugs and metabolites in biological samples.
What are common sample preparation methods for LC-MS/MS?
Common sample preparation methods include solid-phase extraction (SPE), liquid-liquid extraction (LLE), protein precipitation (PP), and filtration, ensuring the analyte is isolated from the biological matrix for accurate analysis.
What factors are considered in LC-MS method development?
Factors include the analyte's physicochemical properties, solubility, MS/MS scanning and optimization, selecting the best chromatography method, mobile phase optimization, and sample preparation techniques to ensure homogenous solutions.
How is stability assessed in bioanalytical methods?
Stability is evaluated through various experiments, including assessing the analyte's stability during sample collection, long-term and short-term storage, freeze-thaw cycles, and during the analytical process.
What are matrix effects in bioanalysis?
Matrix effects refer to ion suppression or enhancement caused by co-eluting matrix components, impacting an analyte's ionization. Evaluating matrix effects ensures accurate quantification of the analyte in the biological matrix.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “A review on lc-ms/ms in bioanalytical studies”. 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) Quality:
In bioanalytical methods, quality pertains to the precision, accuracy, selectivity, and reproducibility of the method. It ensures that the method delivers reliable data for pharmacokinetic, bioavailability, and toxicokinetic studies, essential for drug development and regulatory compliance.
2) Drug:
Focuses on the pharmacokinetics and bioavailability of drugs within biological matrices. The methods developed aim to quantify drugs and their metabolites with high specificity and sensitivity, vital during the drug discovery and development processes.
3) Substance:
Substance: Refers to the analytes, which may be drugs, metabolites, or biological molecules measured in bioanalytical studies. Proper identification and quantification of these substances are crucial for understanding a drug's action and efficacy.
4) Salt (Salty):
Used in various aspects of sample preparation, such as in protein precipitation and buffer formation. The choice of salt can influence ionization efficiency and stability of the analyte, impacting the overall accuracy and precision of the bioanalytical method.
5) Water:
A common solvent in mobile phases for LC-MS. Its proportion in the mix affects ionization and separation of analytes. Ensuring the right water composition can optimize peak shapes and detection limits.
6) Toxicology:
The field that benefits from bioanalytical methods for assessing drug safety. By evaluating drug concentrations in biological matrices, toxicology studies help in understanding the potential toxic effects of new compounds.
7) Science (Scientific):
Pertains to the empirical basis and rigorous methodology followed in bioanalytical method development and validation. Ensuring the scientific integrity of methods is crucial for producing reliable pharmacokinetic and bioequivalence data.
8) Nagarjuna (Nāgārjuna):
Refers to Acharya Nagarjuna University, one of the affiliations of the authors. The institution supports research in pharmaceutical analysis, contributing to the development of advanced bioanalytical methodologies.
9) Medicine:
Represents the broader context for bioanalytical studies. Accurate quantification of drugs and metabolites in medicine ensures that therapeutic levels are achieved, enhancing treatment efficacy and patient safety.
10) Nirmala (Nirmalā):
Refers to Nirmala College, the affiliated institution of the authors. It supports the Department of Pharmaceutical Analysis, contributing to research and advancements in bioanalytical methodologies.
11) Kumari (Kumārī, Kumāri):
Likely refers to Shantha Kumari, one of the co-authors. Her contributions to research and manuscript preparation help in advancing the understanding of bioanalytical methods in the pharmaceutical field.
12) Blood:
One of the primary biological matrices analyzed in bioanalytical studies. Accurate measurement of drug concentrations in blood is crucial for pharmacokinetic and toxicokinetic analysis to ensure drug efficacy and safety.
13) Pharmacology:
The study of drug actions and interactions essential to bioanalytical studies. Understanding pharmacology helps researchers interpret data from pharmacokinetic and bioequivalence studies, vital for drug development.
14) Discussion:
Discussion: Refers to the collaborative exchange among researchers while preparing the manuscript. It's essential for refining methodologies, validating results, and ensuring the reliability of bioanalytical methods discussed in the paper.
15) Desire:
Desire: Highlights the motivation for developing more specific and sensitive bioanalytical assays, initially driven by the rise of pharmacokinetics. The need for accurate drug quantification has propelled technological and methodological advancements.
16) Glass:
Utilized in various lab equipment and containers for preparing and analyzing samples. Proper use of glass materials ensures the integrity of samples and accuracy of bioanalytical results.
17) Anda (Aṇḍa, Amda, Aṇḍā, Anḍā):
Anda: Refers to Abbreviated New Drug Application, requiring full validation of bioanalytical methods. Ensures generic drugs meet the same high standards of quality, efficacy, and safety as original drugs.
Other Science Concepts:
Discover the significance of concepts within the article: ‘A review on lc-ms/ms in bioanalytical studies’. Further sources in the context of Science might help you critically compare this page with similair documents:
Analytical method, Numerical value, Cross validation, Bioavailability, Long term stability, Liquid chromatography mass spectrometry, Sample analysis, Mobile phase, Internal standard, Multiple reaction monitoring, Solid-phase extraction, Electrospray ionization, Method development, Sample preparation, Sensitivity, Calibration curve, Stability Studies, Method validation, Instrumentation, Mass spectrum, Mean concentration, Stationary phase, Stock Solution, Quantitative determination, Selectivity, Carry over effect, Extraction efficiency, Solvent composition, Clinical laboratories, Standard curve, LC-MS, Pharmacokinetic, Correction factor, Immunoassay.