New UV method for simultaneous estimation of lamivudine and tenofovir.

| Posted in: Science

Journal name: World Journal of Pharmaceutical Research
Original article title: Development and validation of new analytical method for the simultaneous estimation of lamivudine and tenofovir disoproxil fumarate by uv-spectrophotometer
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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Original source:

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Author:

Barri Swathi, B. Subramanyam, C. Lakshmi Prasanna, U. Keerthi, P. Sathwika, A. Samanvi


World Journal of Pharmaceutical Research:

(An ISO 9001:2015 Certified International Journal)

Full text available for: Development and validation of new analytical method for the simultaneous estimation of lamivudine and tenofovir disoproxil fumarate by uv-spectrophotometer

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

Doi: 10.20959/wjpr20235-27669

Copyright (license): WJPR: All rights reserved


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Summary of article contents:

Introduction

The research presented in the article focuses on the development and validation of a UV-spectrophotometric method for the simultaneous estimation of two antiviral drugs, Lamivudine and Tenofovir disoproxil fumarate, in combined pharmaceutical dosage forms. The study aims to create an efficient analytical technique to determine these drugs' concentrations in fixed-dose combinations (FDCs) without interference, thereby complying with the International Conference on Harmonisation (ICH) guidelines for method validation. This method is particularly relevant as both drugs are used in treating hepatitis B virus (HBV) infections and have significant roles in modern therapeutic regimens.

Method Development and Validation

The method developed is based on the simultaneous equation method for UV-spectrophotometric determination. Lamivudine and Tenofovir were measured at their respective wavelengths of 290 nm and 287 nm in a buffer solution mixed with acetonitrile (60:40 v/v). The linearity for the calibration ranges was established from 1-50 µg/ml for both drugs, yielding high regression coefficients (0.995 for Lamivudine and 0.997 for Tenofovir). The method's accuracy was affirmed with recoveries ranging from 99% to 103%, signifying its potential for reliable use in pharmaceutical analyses.

Analytical Performance

The study demonstrated high precision, as reflected by the relative standard deviation (RSD) values being less than 2%. The method's limit of detection (LOD) and limit of quantification (LOQ) were calculated using standard deviations based on calibration curves, resulting in a LOD of 0.264 µg/ml for Lamivudine and 0.331 µg/ml for Tenofovir, with corresponding LOQ values of 0.816 µg/ml and 1 µg/ml, respectively. The analytical performance indicates that this method is suitable for routine quality control (QC) assessments in pharmaceutical formulations containing these active ingredients.

Recovery and Precision Studies

Recovery studies were conducted to validate the method's accuracy further, where standard reference substances were added to the formulations at varying concentrations (80%, 100%, and 120%). The percentage recoveries for Lamivudine and Tenofovir were between 98.56% to 101.7% and 99.23% to 100.3%, respectively. Additionally, the intraday and interday precision studies focused on consistency over time, reinforcing that the proposed method offers reliable and reproducible results for both compounds across multiple measurements.

Conclusion

In conclusion, the UV-spectrophotometric method developed for the simultaneous estimation of Lamivudine and Tenofovir disoproxil fumarate is deemed effective, simple, and cost-efficient. It meets all necessary validation criteria according to ICH guidelines, allowing for routine analysis in pharmaceutical settings. The reliability and precision of this method suggest it can significantly contribute to the quality control processes in pharmaceutical manufacturing and research, thereby supporting ongoing efforts in managing viral infections.

FAQ section (important questions/answers):

What is the aim of the research on Lamivudine and Tenofovir?

The study aimed to develop a UV-Spectrophotometric method for the simultaneous estimation of Lamivudine and Tenofovir disoproxil fumarate in bulk and pharmaceutical dosage forms, validating it according to ICH guidelines.

What techniques were used for the simultaneous estimation of drugs?

The research utilized UV-Spectrophotometric determination, specifically the simultaneous equation method, measuring absorbance at wavelengths 290 nm for Lamivudine and 287 nm for Tenofovir.

What were the linearity ranges for measuring the drugs?

Linearity was established for both Lamivudine and Tenofovir in the concentration range of 1-50 µg/ml, with high regression coefficients of 0.995 and 0.997, respectively.

How accurate is the UV-Spectrophotometric method developed?

The accuracy of the method was confirmed through recovery studies, showing recovery rates between 99-103% for both drugs, ensuring high precision as per ICH guidelines.

What were the limits of detection and quantification for the drugs?

The limits of detection (LOD) were 0.264 µg/ml for Lamivudine and 0.331 µg/ml for Tenofovir, while the limits of quantification (LOQ) were 0.816 µg/ml and 1 µg/ml, respectively.

What acknowledgments were made in the research paper?

Acknowledgments were given to the chairman and principal of Gokula Krishna College of Pharmacy for support, as well as Aurobindo Pharmaceuticals for providing drug samples for the research.

Glossary definitions and references:

Scientific and Ayurvedic Glossary list for “New UV method for simultaneous estimation of lamivudine and tenofovir.”. 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 structured arrangement of information or data typically organized in rows and columns. In the context of the research article, tables are used to present numerical results of experiments, validating the accuracy, precision, and linearity of the UV-Spectrophotometric method for drug estimation, enhancing readability and analysis.

2) Drug:
Drugs are chemical compounds used therapeutically to diagnose, treat, or prevent diseases. The article discusses the simultaneous estimation of multiple drugs, emphasizing the need for accurate analytical methods in quality control and formulation development in the pharmaceutical industry, particularly for combined treatments.

3) Tirupati (Thirupati, Tiruppati):
Tirupati is a city in India known for its historical and cultural significance, especially the Tirumala Venkateswara Temple. In this context, it is relevant as the location of Gokula Krishna College of Pharmacy, where the research was conducted, showcasing the contribution of local institutions to pharmaceutical development.

4) Krishna (Krsna):
Krishna refers to a major Hindu deity, symbolizing knowledge and learning. In this article's context, it highlights Gokula Krishna College of Pharmacy, indicating the institution's foundational values in educating pharmaceutical analysts and fostering research in drug development, tying spirituality and education in this cultural backdrop.

5) Gokula (Go-kula):
Gokula often denotes a significant place associated with Lord Krishna's childhood. In the research, it represents Gokula Krishna College of Pharmacy, suggesting an environment rooted in tradition while advancing modern pharmaceutical studies, integrating cultural heritage with scientific achievements within the institution's framework.

6) India:
India is a diverse nation in South Asia with a rich history and a prominent role in global pharmaceuticals. The article situates its research within Indian pharmaceutical education, emphasizing India's contributions to drug development, research, and the importance of local institutions in enhancing healthcare solutions and analytical methodologies.

7) Powder:
In the pharmaceutical context, powder refers to a solid substance composed of fine particles, commonly used as a form for drug administration. This study involves the powdered tablets containing Lamivudine and Tenofovir, showcasing the method of preparation in analyzing drug formulations and their accurate quantification.

8) Transmission:
Transmission refers to the act of transferring a disease from one individual to another, notably in the context of infectious diseases. In this research, it highlights the role of Tenofovir in preventing mother-to-child transmission of hepatitis B, showcasing the drug's vital importance in public health and therapeutic strategies.

9) Subramanyam:
Subramanyam is a common Indian surname. In the paper, it identifies one of the co-authors of the study, emphasizing collaborative efforts in pharmaceutical research and highlighting the contributions of particular individuals in developing analytical methods, reflecting teamwork's importance in academic pursuits.

10) Measurement:
Measurement refers to determining the dimensions, quantity, or capacity of a substance. In this study, it focuses on the precise absorbance measurements obtained from UV-Spectrophotometry for accurate analysis of drug concentrations, underscoring the importance of measurements in validating analytical methods and quality control in pharmaceuticals.

11) Discussion:
Discussion in research denotes analyzing and interpreting the results. It serves as a critical component in the article, providing a platform for the authors to elucidate their findings, compare data with existing literature, and affirm the significance of their method in pharmaceutical analysis, reflecting on implications for future research.

12) Prasanna:
Prasanna is a common Indian first name and is one of the co-authors of the research. Including Prasanna in the article highlights collaborative efforts in academia, emphasizing the diverse expertise contributing to the study’s design, execution, and analysis, and showcasing the strength of teamwork in scientific inquiry.

13) Relative:
Relative refers to something that is considered in relation to something else. In the article, it pertains to analytical parameters such as the % Relative Standard Deviation (%RSD), which assesses the precision of the method based on the variability of results, illustrating important statistical concepts in research accuracy.

14) Lakshmi (Laksmi):
Lakshmi is a popular Indian name, often associated with the goddess of wealth and prosperity. The inclusion of Lakshmi as a co-author in the study signifies the diverse representation in pharmaceutical research, reinforcing the collaboration of varied backgrounds in contributing to innovative methods in drug analysis.

15) Kirti (Kirtti):
Keerthi is a common name in India. In the context of this article, it refers to one of the authors who contributed to the research. This highlights the collaborative nature of scientific studies, wherein diverse contributors come together to enhance the quality and depth of pharmaceutical research.

16) Viru:
Viru, although not specifically referenced in the article, is a term that can refer to viruses, especially in medical contexts. In this study, it subtly relates to the focus on antiviral medications, as the drugs studied are used in the treatment of viral infections like HIV and HBV, showcasing their clinical relevance.

Other Science Concepts:

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Discover the significance of concepts within the article: ‘New UV method for simultaneous estimation of lamivudine and tenofovir.’. Further sources in the context of Science might help you critically compare this page with similair documents:

Quantitative analysis, Mobile phase, Standard deviation, Recovery percentage, Calibration curve, Pharmaceutical formulation, Recovery studies, Method validation, Absorbance measurement, UV Spectrophotometer, Quantitative determination, Fixed Dose Combination, ICH Guideline.

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