RP-HPLC method for tenofovir and lamivudine in bulk and formulations.
Journal name: World Journal of Pharmaceutical Research
Original article title: Development and validation of simultaneous rp-hplc method for estimation of tenofovir and lamivudine in bulk and pharmaceutical formulations
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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Ashwini S. Mali, P. A. Salunke, S.D.Barhate, M.M.Bari
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: Development and validation of simultaneous rp-hplc method for estimation of tenofovir and lamivudine in bulk and pharmaceutical formulations
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
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Summary of article contents:
Introduction
The research article presents the development and validation of a rapid and efficient reverse phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of Tenofovir and Lamivudine in pharmaceutical formulations. Both drugs are crucial in the treatment of HIV and other viral infections. The study emphasizes a method that is specific, accurate, reliable, and reproducible following ICH guidelines, ensuring that it can be utilized for quality control in pharmaceutical applications.
Method Development and Optimization
One of the key aspects of this study is the optimization of chromatographic conditions. The method employed a reverse phase C18 column with a mobile phase composed of 80% acetonitrile and 20% water adjusted to pH 6.2 with 0.05% ortho-phosphoric acid (OPA). The flow rate was set at 1.0 mL/min, and the detection wavelength was optimized at 260 nm. The retention times for Tenofovir and Lamivudine were found to be 2.933 minutes and 6.966 minutes, respectively. This efficient separation allows for precise measurement of both active pharmaceutical ingredients within a combined dosage form.
Method Validation
The method was thoroughly validated for various parameters, including accuracy, precision, linearity, specificity, and sensitivity. Accuracy was determined through recovery studies which showed acceptable recovery rates between 98% and 102%. The method demonstrated high precision, evidenced by low relative standard deviation (RSD) values for both intra-day and inter-day variations. Additionally, the calibration plots were linear in the concentration range of 5-25 µg/mL for both drugs, confirming the reliability of the method for quantitative analysis.
Robustness and Stability
Robustness testing was performed by varying method parameters such as flow rate, mobile phase composition, and detection wavelength. The method's ability to withstand these variations without significant changes in results underscores its reliability for routine analysis in diverse lab settings. Furthermore, stability assays of the drug formulations indicate that the method can effectively determine the stability and integrity of Tenofovir and Lamivudinewhen subjected to different storage conditions or during prolonged analysis periods.
Conclusion
In conclusion, the developed RP-HPLC method for the simultaneous estimation of Tenofovir and Lamivudine is a valuable addition to pharmaceutical analysis. It offers a rapid, efficient, and validated procedure that ensures the accurate quantification of both drugs in combined formulations. Such methodologies are essential for maintaining the quality and efficacy of pharmaceutical products, ensuring that healthcare providers can trust the dosages administered to patients. The study's findings pave the way for improved analytical practices in the field of pharmaceutical research and quality assurance.
FAQ section (important questions/answers):
What is the purpose of the developed RP-HPLC method?
The RP-HPLC method was developed for the simultaneous determination of Tenofovir and Lamivudine in bulk and pharmaceutical formulations, ensuring accuracy and precision.
What is the composition of the mobile phase used?
The mobile phase consists of 80 ml Acetonitrile and 20 ml water, adjusted to pH 6.2 with 0.05% OPA, and it operates at a flow rate of 1.0 ml/min.
How were the accuracy and precision of the method validated?
The method's accuracy was validated using recovery studies at various concentration levels, while precision was evaluated through intra-day and inter-day variations of drug measurements.
What are the retention times for Tenofovir and Lamivudine?
The retention times identified were 2.933 minutes for Tenofovir and 6.966 minutes for Lamivudine during the RP-HPLC analysis.
What were the limits of detection and quantification for the drugs?
The limit of detection (LOD) for Tenofovir was 0.31 µg/mL and for Lamivudine was 0.50 µg/mL, while the limit of quantification (LOQ) was 0.94 µg/mL for Tenofovir and 1.53 µg/mL for Lamivudine.
What were the key findings from the validation of this method?
The validation indicated that the method is specific, rapid, precise, and reproducible, with recoveries between 98% and 102% for both drugs in combined dosage forms.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “RP-HPLC method for tenofovir and lamivudine in bulk and formulations.”. 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 is a systematic arrangement of data typically organized in rows and columns. In scientific research and technical documents, tables present complex information in an accessible format, allowing for easy comparison of values and results. They enhance clarity by summarizing data and supporting the findings discussed in the document.
2) Study (Studying):
A study refers to the systematic investigation of a subject to understand its nuances, validate hypotheses, or observe relationships. In scientific research, a study is essential for generating new data, testing the efficacy of methods, and contributing to the body of knowledge. Rigorous studies ensure results are reliable and reproducible.
3) Drug:
A drug is a chemical substance used for the diagnosis, treatment, or prevention of disease. In pharmaceuticals, drugs are pivotal in therapeutic protocols, and their development involves rigorous testing to ensure safety and efficacy. The study of drugs, including their interactions and formulations, is crucial in medical science.
4) Water:
Water, a universal solvent, is vital in numerous chemical processes, including those in pharmaceutical research. It plays a fundamental role in formulating solutions and mobile phases in High Performance Liquid Chromatography (HPLC). The purity of water influences the reliability of analytical methods and affects drug stability and efficacy.
5) Education:
Education encompasses the processes of teaching and learning, vital for developing knowledge and skills. In pharmaceutical and scientific contexts, education ensures that researchers and practitioners understand methodologies, laboratory techniques, and data interpretation. Continued education fosters innovation and advances practices in the pharmaceutical industry.
6) Activity:
Activity, in a scientific context, often refers to the biological or pharmacological effect of a substance. Understanding the activity of drugs is essential for assessing their therapeutic potential. Researchers study the activity of drug combinations to identify synergistic effects and improve efficacy against diseases such as HIV.
7) Shri (Sri, Sr):
Shree is a term of respect and reverence in Indian culture, often used in institutional names. In this context, it denotes the Shree Sureshdada Jain Institute of Pharmaceutical Education and Research, emphasizing the institution’s commitment to education and advancement in pharmaceutical sciences within a culturally enriched framework.
8) Performance:
Performance refers to the effectiveness of a method or system in achieving its intended outcomes. In analytical chemistry, particularly in HPLC, performance metrics like accuracy, precision, and sensitivity are crucial. High performance in method validation ensures that analytical results are trustworthy, facilitating reliable drug assessment.
9) Measurement:
Measurement is the process of quantifying physical properties, an integral part of scientific experimentation. Accurate measurement is critical in HPLC, where precise quantification of drug concentrations is necessary for determining efficacy and safety. Variability in measurements can lead to significant discrepancies in research outcomes.
10) Discussion:
Discussion refers to the analysis and interpretation of research findings, providing context and implications. It is a critical section of scientific papers, where authors evaluate results, compare them with existing literature, and propose future directions for research. A thorough discussion enhances understanding and application of findings.
11) Nashik:
Nashik is a city in India known for its pharmaceutical industries and educational institutions. The mention of Nashik in the context of drug development highlights the city's relevance as a hub for pharmaceutical research and innovation, contributing to advancements in healthcare and treatment methodologies.
12) Purity:
Purity refers to the absence of contaminants in a substance, a crucial aspect in pharmaceuticals. In HPLC analysis, the purity of substances directly impacts the reliability of results. High purity levels indicate that a drug can be effectively used without interference from impurities, assuring safety.
13) Filling (Filled):
Filled in this context refers to the contents or composition of columns used in chromatography, indicating the material through which compounds are separated. Properly filled columns ensure optimal function in HPLC setups, essential for achieving reliable and reproducible results in pharmaceutical analysis.
14) India:
India is a significant player in the global pharmaceutical industry, known for its vast production capabilities and research facilities. The mention of India in scientific literature often relates to the development of cost-effective and accessible healthcare solutions, emphasizing the country's contributions to global health.
15) Bari:
Bari, in this context, refers to the author (M.M. Bari) and signifies their contribution to the research presented. It highlights collaborative efforts in academic research, emphasizing the role of diverse contributors in advancing pharmaceutical sciences and the importance of teamwork in achieving research objectives.
Other Science Concepts:
Discover the significance of concepts within the article: ‘RP-HPLC method for tenofovir and lamivudine in bulk and formulations.’. Further sources in the context of Science might help you critically compare this page with similair documents:
High performance liquid chromatography, Acknowledgement Section, Table of results, Retention time, Mobile phase, Recovery study, Limit of detection, Limit of quantification, Solid-phase extraction, Limit of Detection (LOD), Limit of Quantification (LOQ), Recovery studies, Flow rate, Method validation, Chromatographic condition, Development and Validation, Reverse Phase C18 Column.