Validated RP-HPLC method for sofosbuvir and ledipasvir in tablets.
Journal name: World Journal of Pharmaceutical Research
Original article title: A new validated stability indicating rp-hplc method for simutaneous estimation of sofosbuvir and ledipasvir in tablet dosage forms
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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D. Vinay Kumar and JVLN Seshagiri Rao
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World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: A new validated stability indicating rp-hplc method for simutaneous estimation of sofosbuvir and ledipasvir in tablet dosage forms
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
Doi: 10.20959/wjpr201817-13124
Copyright (license): WJPR: All rights reserved
Summary of article contents:
1) Introduction
Hepatitis C virus (HCV) infection has emerged as a major global public health challenge, affecting approximately 130-150 million individuals and resulting in nearly 400,000 deaths annually due to related conditions like cirrhosis and hepatocellular carcinoma. The combination of Sofosbuvir, a direct-acting antiviral agent, and Ledipasvir, an HCV NS5A inhibitor, is commonly used in treating chronic hepatitis C infection. In this study, a new validated stability-indicating reversed-phase high-performance liquid chromatography (RP-HPLC) method was developed for the simultaneous estimation of Sofosbuvir and Ledipasvir in tablet dosage forms, adhering to International Conference on Harmonization (ICH) guidelines.
2) Development and Validation of RP-HPLC Method
The newly developed RP-HPLC method utilized a Kromosil C18 column and a mobile phase comprised of Acetonitrile and 0.1% orthophosphoric acid in a 35:65 volume ratio. The method demonstrated notable precision and accuracy, as evidenced by retention times of 2.516 minutes and 3.743 minutes for Sofosbuvir and Ledipasvir, respectively. Linearity was established in the concentration ranges of 100-600 µg/ml for Sofosbuvir and 22.5-135 µg/ml for Ledipasvir, with high regression coefficients of 0.999. System suitability parameters, such as plate counts and tailing factors, were validated, confirming the method's effectiveness for routine analysis.
3) Stability and Forced Degradation Studies
Forced degradation studies were conducted to assess the stability-indicating nature of the developed method under various stress conditions, including oxidation, acid, alkaline, thermal, and neutral degradation. The results showed that both drugs maintained a high percentage of retention in these conditions, indicating the robustness of the method. Specifically, the degradation under forced conditions provided insights into the chemical behavior of Sofosbuvir and Ledipasvir, and the stability assessment was in accordance with ICH guidelines—highlighting the method's suitability for evaluating drug stability and quality.
4) Accuracy and Precision Analysis
Accuracy of the RP-HPLC method was evaluated using recovery studies, which indicated mean recoveries of 100.16% for Sofosbuvir and 99.78% for Ledipasvir across different concentration levels (50%, 100%, and 150%). The method's precision was confirmed through intra-day and inter-day studies, with %RSD values below 2%, indicating a high degree of reproducibility. These assessments reinforced the method's reliability and demonstrated its potential for quantifying both drugs in pharmaceutical formulations effectively.
5) Conclusion
The developed RP-HPLC method is a simple, precise, and reliable approach for the simultaneous estimation of Sofosbuvir and Ledipasvir in combined tablet dosage forms. Its high accuracy, linearity, and robustness, alongside successful forced degradation studies, affirm its applicability for routine laboratory analysis. This method not only enhances analytical capabilities in pharmaceutical settings but also adheres to ICH guidelines, making it a valuable tool for monitoring the stability and integrity of these critical antiviral compounds.
FAQ section (important questions/answers):
What is the purpose of the developed RP-HPLC method?
The developed RP-HPLC method is designed for the simultaneous estimation of Sofosbuvir and Ledipasvir in combined tablet dosage forms while validating its stability and accuracy as per ICH guidelines.
What are the retention times for Sofosbuvir and Ledipasvir?
The retention times obtained for Sofosbuvir and Ledipasvir were 2.516 minutes and 3.743 minutes, respectively, during the HPLC analysis.
What was the recovery rate for the drugs in the study?
The mean recovery rates were noted as 100.16% for Sofosbuvir and 99.78% for Ledipasvir, indicating good accuracy of the proposed method.
How was the method validated for precision?
The method's precision was established through reproducibility studies, achieving %RSD values of less than 2%, demonstrating consistent results across multiple samplings.
What types of degradation were studied for the drugs?
Forced degradation studies included conditions of oxidation, acid, alkaline, thermal, photo stability, and neutral degradation to assess the stability of Sofosbuvir and Ledipasvir.
What are the LOD and LOQ for the drugs?
The limit of detection (LOD) was 1.22 µg/mL for Sofosbuvir and 0.184 µg/mL for Ledipasvir; the limit of quantification (LOQ) was 3.70 µg/mL and 0.557 µg/mL, respectively.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “Validated RP-HPLC method for sofosbuvir and ledipasvir in tablets.”. 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 keyword 'Drug' refers to the chemical substances used in the treatment or prevention of diseases, including antiviral agents like Sofosbuvir and Ledipasvir. The text discusses the development and analysis of these drugs to treat Hepatitis C, highlighting the importance of understanding their stability and efficacy in pharmaceutical formulations.
2) Table:
In the context of the text, 'Table' refers to the dosage form of the drugs. Specifically, it discusses tablet formulations containing Sofosbuvir and Ledipasvir. The stability studies and quantitative analyses mentioned relate to these tablet forms, emphasizing the need for reliable methods for drug content analysis in solid dosage forms.
3) Kumar:
'Kumar' is mentioned as an author of the research article. It symbolizes the contribution of researchers in the pharmaceutical field, indicating the importance of collaboration and knowledge generation. The work attributed to Kumar and colleagues focuses on validating a new RP-HPLC method for drug analysis, showcasing the significance of authorship in scientific discourse.
4) Water:
'Water' is a critical component in the preparation of buffers and diluents for the analysis processes mentioned in the text. Its use is essential for achieving the right chemical environment necessary for High-Performance Liquid Chromatography (HPLC). Water quality directly impacts the outcome of the analytical procedures and, consequently, the validity of the results.
5) Purity:
'Purity' refers to the measurement of the amount of an active pharmaceutical ingredient present without contamination from impurities or degradation products. The text discusses forced degradation studies, which help assess the purity of Sofosbuvir and Ledipasvir. High purity is essential for ensuring the efficacy and safety of drugs administered to patients.
6) Viru:
'Viru' is an incomplete reference likely intended to refer to 'virus', specifically the Hepatitis C virus (HCV) discussed in the context of the diseases treated by drugs such as Sofosbuvir and Ledipasvir. Understanding viruses is crucial in pharmaceutical research, as it aids in the development of targeted therapies against viral infections.
7) Science (Scientific):
'Science' in this context refers to the systematic study of the natural world, particularly in pharmaceutical research. The article embodies scientific rigor, highlighting empirical experimentation, method validation, and stability studies that are foundational to drug development. The use of scientific methodology in analyzing drug interactions is paramount for future clinical applications.
8) Substance:
'Substance' denotes the active ingredients, specifically Sofosbuvir and Ledipasvir, examined in the study. It emphasizes the chemical composition of the drugs and their interaction with biological systems. Understanding the properties and behaviors of these substances is vital for developing effective treatments for Hepatitis C infections.
9) Blood:
'Blood' is highlighted as a medium of transmission for the Hepatitis C virus (HCV). The text outlines the relevance of understanding viral infections, which are often bloodborne. Studying the interaction of drugs with the disease caused by viruses like HCV is crucial for developing effective therapeutic strategies.
10) Study (Studying):
'Studying' highlights the ongoing efforts to understand the properties and behaviors of Sofosbuvir and Ledipasvir in pharmaceutical contexts. This continuous learning process is vital for improving drug formulations and therapeutic strategies. Studying these compounds contributes to the advancement of medical science and effective disease management.
11) Transformation (Transform, Transforming):
'Transformation' refers to changes that the drugs undergo during their degradation under various conditions. The article discusses forced degradation studies, highlighting how understanding these transformations is essential for characterizing the stability and efficacy of the drugs. Analyzing these changes provides insights into drug shelf-life and safety.
12) Performance:
'Performance' reflects how well the developed RP-HPLC method operates in terms of accuracy, precision, and reliability in drug analysis. Evaluating method performance through validation parameters ensures that it meets the required standards for pharmaceutical applications, ensuring patient safety and compliance with regulatory guidelines.
13) Discussion:
'Discussion' encompasses the analysis and interpretation of results provided in the study. In academic texts, discussion sections elaborate on findings, relate them to existing literature, and suggest implications for future research. This segment of scientific writing is crucial for contextualizing results within the wider field of pharmaceutical sciences.
14) Quality:
'Quality' pertains to ensuring that pharmaceutical products are safe, effective, and meet the specified standards. The text discusses the assessment and validation of the developed method, underscoring the necessity of maintaining high-quality standards in drug production to ensure patient safety and therapeutic efficacy.
15) Disease:
'Disease' refers to the medical conditions being treated or prevented through pharmaceutical intervention. In this context, Hepatitis C is the focal disease, and the document discusses how specific drugs target this virus. Understanding disease mechanisms is crucial for developing effective treatment options and improving public health outcomes.
16) Andhra (Amdhra):
'Andhra' refers to the state in India, which is home to Andhra University, where part of the research was conducted. This geographic identifier establishes the context of the study and highlights the contributions of various institutions in advancing pharmaceutical sciences and research initiatives in specific regions.
17) Powder:
'Powder' typically refers to a form in which pharmaceutical compounds can be processed before being formulated into tablets or other dosage forms. The research discusses the grinding of tablets into powder for analysis. The powdered state is essential for accurate dosage measurements and subsequent qualitative and quantitative analysis in pharmaceuticals.
18) Food:
'Food' is not directly referenced in the text; however, it evokes considerations about drug interactions with nutritional substances. Understanding how drugs like Sofosbuvir and Ledipasvir interact with food is essential in creating guidelines for patient care, ensuring safe and effective administration of medications in conjunction with dietary habits.
Other Science Concepts:
Discover the significance of concepts within the article: ‘Validated RP-HPLC method for sofosbuvir and ledipasvir in tablets.’. Further sources in the context of Science might help you critically compare this page with similair documents:
Retention time, Linearity range, Limit of Detection (LOD), Limit of Quantification (LOQ), System Suitability, RP-HPLC Method, Forced degradation studies, Method validation, Tablet dosage form, Detection wavelength, Hepatitis C virus, Quantitative analyses.