HPLC method for tolperisone hydrochloride in human plasma.
Journal name: World Journal of Pharmaceutical Research
Original article title: Bioanalytical method development and validation for estimation of tolperisone hydrochloride in human plasma 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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Sonali Mahaparale, Indrajeet Gonjari
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: Bioanalytical method development and validation for estimation of tolperisone hydrochloride in human plasma by hplc
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
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Summary of article contents:
Introduction
Tolperisone hydrochloride is a centrally-acting muscle relaxant employed in treating acute muscle spasms and spasticity associated with neurological diseases. Due to its unique properties, such as inducing muscle relaxation without sedation and not causing weakness or mental confusion, it is preferred over other muscle relaxants. This article discusses the development and validation of a High-Performance Liquid Chromatography (HPLC) method for quantifying Tolperisone hydrochloride in human plasma, which is crucial for pharmacokinetic and bioequivalence studies.
Method Development and Validation
The HPLC method was developed using a Chromasil C18 column, with an acetonitrile-water mobile phase at a 60:40 ratio and an adjusted pH of 3.0. The flow rate was maintained at 1.0 mL/min, and the detection occurred at 260.0 nm. The method involved preparing a standard stock solution of Tolperisone and an internal standard, Eperisone hydrochloride, and utilizing acetonitrile as a precipitating agent for plasma sample processing. The linear range of the assay was established as 50-2000 ng/mL, with a regression coefficient of 0.9990, indicating high linearity and reliability in the quantification of Tolperisone.
Recovery and Precision
The recovery of Tolperisone from plasma samples was assessed for accuracy and precision. The average recovery rate was 74.22%, while intra- and inter-day precision evaluations showed consistent results across different concentrations. Specifically, the coefficients of variation (CV) for low, middle, and high-quality control samples demonstrated the method's reliability. Such precision is pivotal in ensuring that the quantification of Tolperisone in the plasma is consistent and credible, which is essential for subsequent pharmacokinetic analyses.
Stability and Limit of Quantification
The method was validated for various stability aspects, including short-term, long-term, and freeze-thaw stability of Tolperisone hydrochloride in plasma. The limit of quantification (LOQ) was found to be 50 ng/mL, indicating the lowest concentration at which the drug can be reliably quantified while maintaining acceptable accuracy and precision. This sensitivity allows for effective monitoring of drug levels in clinical settings, showcasing the method's practicality for pharmacokinetic studies.
Conclusion
The validated HPLC method for quantifying Tolperisone hydrochloride in human plasma is characterized as simple, rapid, accurate, and precise. This method is a highly valuable tool for conducting bioavailability, bioequivalence, and pharmacokinetics studies involving Tolperisone, offering a practical and economical alternative for researchers in the pharmaceutical field. The authors express gratitude to contributing institutions for providing resources and materials essential for the research.
FAQ section (important questions/answers):
What is Tolperisone hydrochloride and its therapeutic use?
Tolperisone hydrochloride is a centrally-acting muscle relaxant used primarily for treating acute muscle spasms and spasticity associated with neurological conditions.
Which method was developed for analyzing Tolperisone in plasma?
A validated High Performance Liquid Chromatography (HPLC) method with UV detection was developed for the determination of Tolperisone hydrochloride in human plasma.
What is the role of Eperisone hydrochloride in the study?
Eperisone hydrochloride was used as an internal standard in the HPLC method for accurate quantification of Tolperisone hydrochloride in plasma samples.
What were the limits of quantification for the method?
The method demonstrated a limit of quantification of 50 ng/ml for Tolperisone hydrochloride in human plasma, ensuring sensitivity in analysis.
What was the recovery percentage for Tolperisone hydrochloride?
The mean recovery percentage for Tolperisone hydrochloride was found to be 74.22%, indicating the method's efficiency in extracting and quantifying the drug from plasma.
What are the benefits of this HPLC method?
This HPLC method is simple, rapid, accurate, precise, and economical, making it a valuable tool for pharmacokinetic and bioequivalence studies involving Tolperisone hydrochloride.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “HPLC method for tolperisone hydrochloride in human 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) Table:
Tables are essential tools in scientific articles to organize and present data clearly. In this study, various tables summarize results such as intraday and interday precision, accuracy, recovery percentages, and stability of Tolperisone hydrochloride. Properly structured tables enhance comprehension and facilitate comparison of experimental data.
2) Quality:
Quality refers to the degree of excellence or superiority of a method or product. In the context of this research, quality relates to the precision, accuracy, and reliability of the HPLC method used for quantifying Tolperisone hydrochloride in plasma, which is critical for ensuring valid pharmacokinetic studies.
3) Drug:
A drug is a substance used to treat, cure, prevent, or diagnose disease; in this work, Tolperisone hydrochloride is the specific drug being analyzed. It is a muscle relaxant indicated for treating acute muscle spasms, making its accurate quantification in plasma essential for therapeutic monitoring and clinical studies.
4) Pune:
Pune is a city in Maharashtra, India, where significant institutions such as colleges of pharmacy and pharmaceutical companies are located. The research conducted at Padmashree Dr. D. Y. Patil College of Pharmacy and collaborations with local pharmaceutical firms like Emcure exemplify Pune's role in advancing pharmaceutical research and development.
5) Maharashtra (Maharastra, Maha-rashtra):
Maharashtra is a state in India known for its economic and educational significance. It houses numerous pharmaceutical firms and research institutions. The research on Tolperisone hydrochloride represents the innovative contributions emerging from Maharashtra's academic and industrial sectors, aimed at improving healthcare and drug development.
6) India:
India serves as a key player in global pharmaceuticals, contributing to drug development and research. The studies conducted in India, like the one on Tolperisone hydrochloride, highlight the country's growing capabilities in biotechnology and pharmaceuticals, addressing both local health needs and international markets.
7) Patil:
Patil refers to Padmashree Dr. D. Y. Patil College of Pharmacy, an institution prominent in pharmaceutical education and research. This college plays a vital role in preparing skilled professionals in pharmacy, conducting research like the validation of analytical methods for drugs, thereby enhancing healthcare education in India.
8) Water:
Water serves as a mobile phase component in the HPLC method described in the study. It is crucial for dissolving substances, facilitating the separation of Tolperisone hydrochloride from the plasma matrix, and ensuring reliable chromatographic results. The effectiveness of the mobile phase influences the precision of the measurements.
9) Measurement:
Measurement pertains to the process of quantitatively determining the characteristics of a substance, such as concentration levels in this study of Tolperisone hydrochloride. Accurate and repeatable measurements are fundamental for validating analytical methods, ensuring that the results are reliable and consistent within pharmacological applications.
10) Study (Studying):
A study refers to scientific research aimed at understanding, analyzing, or validating hypotheses, such as the pharmacokinetics of a drug. This research on Tolperisone hydrochloride evaluates an HPLC method for estimating drug levels in plasma, contributing significant insights into its therapeutic use and effectiveness.
11) Noise:
Noise in analytical chemistry refers to any unwanted disturbance in the measurement process that can interfere with the detection of a signal. In this study, controlling noise is critical to ensure that the quantification of Tolperisone hydrochloride is accurate and that the results reflect true drug concentrations in plasma.
12) Pain:
Pain is a critical condition often treated with muscle relaxants like Tolperisone hydrochloride. The significance of the drug's quantification in plasma relates directly to its efficacy in managing muscle-related pain, making pharmacokinetic studies essential for validating therapeutic dosages and optimizing patient care.
13) Performance:
Performance generally refers to the effectiveness and efficiency of a method or process. In this study, the performance of the HPLC method is evaluated through parameters such as precision, accuracy, and recovery, which are crucial for ensuring that the method is suitable for pharmacokinetic and bioequivalence studies.
14) Discussion:
The discussion section of a research paper interprets findings, explores implications, and relates them to existing knowledge in the field. Here, it may analyze how the developed HPLC method for Tolperisone hydrochloride compares to others, its potential impact on clinical practices, and future research avenues.
15) Relative:
Relative refers to a comparative measure of one entity to another. In this context, it is essential for discussing the performance metrics of the analytical method and comparing them with established methods or standards, helping to demonstrate the robustness and advantages of the developed HPLC technique.
16) Disease:
Disease refers to pathological conditions that affect bodily functions, often requiring medical treatment. The study focuses on Tolperisone hydrochloride, which is applied in treating muscle spasms related to various diseases, highlighting the importance of accurate drug quantification for effective medicinal use.
17) Medium:
Medium indicates the environment or substance through which drugs are administered or measured. In this study, the medium is human plasma, which is critical for assessing the pharmacokinetics of Tolperisone hydrochloride, ensuring that the drug's effects can be accurately evaluated in a biological context.
18) Glass:
Glass is a material used in laboratory settings, particularly for sample containment and processing. In this study, glass tubes are utilized for sample preparation, ensuring that the interaction between the plasma samples and the measurement methods are unhindered, thereby facilitating precise quantification of the drug.
Other Science Concepts:
Discover the significance of concepts within the article: ‘HPLC method for tolperisone hydrochloride in human plasma.’. Further sources in the context of Science might help you critically compare this page with similair documents:
High performance liquid chromatography, Long term stability, Stability study, Recovery study, Limit of detection, Limit of quantification, Internal standard, HPLC Method, Calibration curve, Intraday precision, Interday precision, Percentage recovery, Method validation, Pharmacokinetic studies, Signal to noise ratio.