Chromatographic development for valganciclovir impurities and stability.
Journal name: World Journal of Pharmaceutical Research
Original article title: Chromatographic method development and validation stability-indicating five impurities and its degradation products in valganciclovir hydrochloride powder for oral solution, 50 mg/ml
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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†Naresh Chandra Reddy Male and ††Kavitha Male
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: Chromatographic method development and validation stability-indicating five impurities and its degradation products in valganciclovir hydrochloride powder for oral solution, 50 mg/ml
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
Doi: 10.20959/wjpr20232-26972
Copyright (license): WJPR: All rights reserved
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Summary of article contents:
Introduction
Valganciclovir hydrochloride is an antiviral medication approved by the FDA for preventing and treating cytomegalovirus (CMV) retinitis in immunocompromised patients, such as those with AIDS or organ transplant recipients. Due to the clinical importance of Valganciclovir, there has been a rising need for effective methods to quantify its purity and identify related impurities. The study by Naresh Chandra Reddy Male and colleagues presents a novel reverse-phase high-performance liquid chromatography (RP-HPLC) method, focusing on the separation and quantification of five known impurities in Valganciclovir hydrochloride powder for oral solution.
Development of the RP-HPLC Method
The RP-HPLC method developed utilizes a Zorbax SB C18 column and employs a gradient mobile phase consisting of Ammonium Phosphate Monobasic buffer and Methanol, with UV detection at 254 nm. The method successfully separates known impurities such as Ganciclovir, Guanine, Bis Valine Ester, Methoxymethylguanine, and Monoacetoxyganciclovir. Comprehensive validation was performed to assess method parameters, including linearity, specificity, precision, accuracy, robustness, and ruggedness, adhering to ICH guidelines. This thorough development highlights the method's suitability for routine analysis of Valganciclovir and its impurities.
System Suitability and Validation
To ensure the reliability of the RP-HPLC method, system suitability tests were conducted by injecting six standard solutions. Key parameters like theoretical plates, asymmetry, and relative standard deviation (RSD) were quantified, yielding results that confirmed the method’s adequacy for impurity estimation. The study also evaluated specificity through placebo interference and concluded that no interference from blank or known impurities affected the method's performance. The limit of quantitation (LOQ) and limit of detection (LOD) were calculated, underpinning the method's effectiveness in identifying impurities at low concentrations.
Forced Degradation Studies
Forced degradation studies were integral to evaluating the stability and degradation pathways of Valganciclovir. Various stress conditions such as acid and base hydrolysis, oxidation, water hydrolysis, heat stress, and photolytic exposure were applied to assess the drug's stability. The findings demonstrated the method's capability to simulate real-life conditions under which the drug might degrade, providing vital information for formulating and storing Valganciclovir HCl effectively. The study detailed recovery rates and impurity formations under these stress tests, reinforcing the robustness of the analytical method.
Conclusion
The proposed RP-HPLC method for quantifying Valganciclovir hydrochloride and its impurities has been validated as accurate, sensitive, and reliable. By satisfying stringent validation parameters outlined by ICH guidelines, this method emerges as a vital tool for pharmaceutical quality control, ensuring the safety and efficacy of Valganciclovir formulations. The study's findings contribute significantly to the understanding of Valganciclovir stability and the management of impurities, highlighting its applicability in regular laboratory analysis.
FAQ section (important questions/answers):
What is the purpose of the developed RP-HPLC method?
The RP-HPLC method was developed for the estimation of Valganciclovir HCl and its known impurities, ensuring accurate separation and quantification in powder formulations used for oral solutions.
What are the main impurities identified in Valganciclovir HCl?
The main impurities identified include Ganciclovir, Guanine, Bis Valine Ester, Methoxymethylguanine, and Monoacetoxyganciclovir, which are crucial for stability-indicating assays.
How was the method validated?
The method was validated according to ICH guidelines, evaluating parameters such as linearity, specificity, accuracy, robustness, and precision to ensure reliable results during analysis.
What are the chromatographic conditions used?
Chromatographic conditions involve using a Zorbax SB C18 column with a gradient mobile phase of ammonium phosphate buffer and methanol, at a flow rate of 1.0 ml/min.
What were the results of the accuracy assessment?
The accuracy assessment indicated that recovery percentages ranged from 90% to 110% across various concentrations, confirming the method's effectiveness for analyzing Valganciclovir HCl impurities.
What stressed conditions were tested for stability?
Stability under harsh conditions included acid and base hydrolysis, oxidation, heat treatment, and exposure to UV light, indicating the method's capability to evaluate degradation products.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “Chromatographic development for valganciclovir impurities and stability.”. 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 in scientific research serves as a structured format to present data clearly, allowing for easier comparison and analysis. Tables can summarize experimental results, numerical values, and statistical analyses, providing a concise reference for readers to understand findings quickly without sifting through extensive text.
2) Water:
Waters refers to the company Waters Corporation, which is well-known for its contributions to analytical chemistry equipment, particularly High-Performance Liquid Chromatography (HPLC) systems. Such technologies are fundamental in pharmaceutical analysis for ensuring the quality and safety of drug products, thereby enhancing healthcare outcomes.
3) Study (Studying):
Study refers to a systematic examination or investigation of a particular subject or phenomenon. In this context, a study outlines the research methodologies, experiments, and analyses conducted to explore the properties of Valganciclovir HCl and its impurities, ensuring reliable and reproducible results in pharmaceutical science.
4) Powder:
Powder describes a solid substance composed of finely dispersed particles. In pharmaceuticals, drug powders form the basis for oral solutions, tablets, or other formulations. Understanding the properties, stability, and degradation of drug powders, like Valganciclovir HCl, is vital to assure efficacy and safety in medical applications.
5) India:
India is a country known for its vast pharmaceutical industry, which plays a significant role in global drug manufacturing and research. The presence of reputable educational institutions and research centers, such as Jawaharlal Nehru Technological University, contributes to advancements in drug analysis, quality control, and method development.
6) Purity:
Purity represents the absence of contaminants and impurities in a substance, critical for pharmaceuticals. High purity levels ensure the safety and efficacy of drugs, such as Valganciclovir HCl. Analytical techniques validate purity through predefined specifications to meet regulatory requirements, helping protect patient health.
7) Drug:
A drug is a biologically active compound that alters physiological functions in the body. Valganciclovir HCl is an antiviral drug used for treating cytomegalovirus infections. Understanding its chemical properties, impurities, and interactions through method development is essential for ensuring safe and effective patient care.
8) Substance:
A substance is a specific form of matter with uniform properties. In the context of a pharmaceutical analysis, this may refer to active pharmaceutical ingredients or their related impurities. Analyzing these substances helps manufacturers ensure the safety, efficacy, and quality of the drug product.
9) Disease:
Diseases encompass various pathological conditions that cause health complications. Understanding diseases, particularly viral infections targeted by specific drugs like Valganciclovir HCl, informs clinical treatment and preventive strategies, emphasizing the importance of robust pharmaceutical analyses in developing effective therapies for those conditions.
10) Noise:
Noise refers to extraneous signals that can obscure the desired information in analytical methods. In chromatography, high levels of noise reduce the clarity and detection of peaks in chromatograms, making it challenging to accurately quantify substances like impurities. Maintaining low noise levels is crucial for reliable results.
11) Male:
Male refers to the gender identities of individuals. In the context of this research, Naresh Chandra Reddy Male and Kavitha Male are mentioned as authors. Their contributions to the scientific study underscore the importance of diverse perspectives and expertise in pharmaceutical research and method development.
12) Collecting:
Collecting in a research context refers to the systematic gathering of data samples, experimental results, or analytical observations. Collecting information accurately and thoroughly is crucial in validating scientific methodologies, ensuring repeatability, and assembling robust evidence for evaluating the properties and impurities of drugs like Valganciclovir HCl.
13) Chandra:
Chandra likely refers to Naresh Chandra Reddy Male, one of the authors of the research paper. The contributions and expertise of researchers like Chandra are invaluable in advancing pharmaceutical sciences and developing reliable analytical methods to ensure the safety and efficacy of medications.
14) Calculation:
Calculation refers to the systematic mathematical evaluation of data to derive quantitative results. In pharmaceutical analysis, calculations involve quantifying impurities, assessing recovery rates, and determining analytical parameters such as limits of detection (LOD) and quantitation (LOQ) to ensure accurate drug characterization and compliance.
15) Discussion:
Discussion in scientific literature provides a detailed interpretation of experimental results. It allows researchers to explain their findings, compare them to existing literature, and address the implications for regulatory compliance, patient safety, and future research directions focusing on the assessed pharmaceutical products.
16) Similarity:
Similarity, in analytical contexts, often refers to the close match in behavior or characteristics between compounds. Establishing the similarity of impurities to the main therapeutic compound in pharmaceuticals is essential in ensuring the specificity of analytical methods and preventing potential adverse effects in formulated products.
17) Medicine:
Medicine is the science and practice of diagnosing, treating, and preventing diseases. In this context, Valganciclovir HCl exemplifies a medicinal product aimed at combating specific viral infections. Understanding drug properties, stability, and analytical methods is paramount for the efficacy of treatments in medical settings.
18) Nakar:
Nagar typically refers to an urban area or neighborhood in India. In scientific contexts, such regions may host various pharmaceutical companies, research institutions, and universities where significant advancements in drug development and analysis occur, contributing to India's role as a global leader in pharmaceuticals.
19) Food:
Food encompasses substances consumed for nutritional value and energy. Understanding pharmaceutical compounds' interactions with food is essential as dietary components may influence drug absorption and metabolism, affecting efficacy and safety. Research in this area underscores the importance of patient management during medication use.
20) Dish (Dis):
A dish, in scientific terms, often refers to a laboratory container used in experiments. In this context, it may denote the quartz culture dishes used for photolytic stress studies of medicines. Proper dish selection ensures effective interaction with light and facilitates accurate analytical assessments.
Other Science Concepts:
Discover the significance of concepts within the article: ‘Chromatographic development for valganciclovir impurities and stability.’. Further sources in the context of Science might help you critically compare this page with similair documents:
Tablet formulation, Limit of detection, Sample preparation, Limit of Detection (LOD), Limit of quantitation, Chromatographic condition, Liquid chromatography, Chromatographic method.