New spectroscopic method for estimating valgancyclovir HCl.
Journal name: World Journal of Pharmaceutical Research
Original article title: Development and validation of new spectroscopic method for the estimation of valgancyclovir hcl in bulk and pharmaceutic dosage form
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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Sathish Kumar Konidala, N Yamini Sai Silpa, K Samrajyam, O Tulasi Durga Deviand Dr R Srinivasan
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: Development and validation of new spectroscopic method for the estimation of valgancyclovir hcl in bulk and pharmaceutic dosage form
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
Copyright (license): WJPR: All rights reserved
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Summary of article contents:
Introduction
The study conducted by Sathish et al. aimed to develop a simple, accurate, and cost-effective UV-spectrophotometric method for the estimation of Valganciclovir HCl, an anti-HIV drug, in bulk and pharmaceutical dosage forms. The research highlights the importance of developing analytical methods that can facilitate the determination of drug concentration for quality control in pharmaceutical formulations. By employing a UV-spectrophotometer, the researchers determined the absorption maximum (λmax) of Valganciclovir to be 250 nm, demonstrating a linear response between 4-20 µg/mL with a regression coefficient of 0.999, adhering to the guidelines set forth by the International Conference for Harmonization (ICH).
Solubility and Method Development
The solubility of Valganciclovir was tested across various solvents, showcasing that 0.1N HCl was optimal for the method development. The preparation of stock and working solutions was conducted meticulously to ensure accurate concentrations. As a foundational step, absorbance measurements were taken at the determined λmax. The calibration curve established from various dilutions confirmed that the chosen wavelength and solvent effectively support the reliable quantification of Valganciclovir, thereby setting the stage for the analytical assessments to follow.
Method Validation
To establish the reliability of the spectrophotometric method, comprehensive validation was conducted following ICH parameters, including linearity, accuracy, precision, robustness, and ruggedness. The method demonstrated strong linearity within the selected concentration range, with correlation coefficients attaining values around 0.999. Accuracy was validated through recovery studies, yielding results between 98.00% and 101.4%, indicating that the method can precisely reflect the actual drug content. Intra-day and inter-day precision were assessed, and both yielded %RSD values below 2%, supporting the robustness of the method.
Results and Discussion
The developed method’s efficacy was further corroborated by determination limits: the Limit of Detection (LOD) and Limit of Quantification (LOQ) were established at sub-microgram levels, indicating high sensitivity. The validation demonstrated that the method shows no interference from excipients typically found in pharmaceutical formulations, thereby confirming its applicability for routine analysis. The assay results for the marketed VALGAN tablets conformed to the label claim of 450 mg Valganciclovir, with a mean recovery of 99.60%, reinforcing the method’s reliability and consistency in practical use.
Conclusion
In summary, the presented UV-spectrophotometric method offers a reliable, accurate, and straightforward approach for estimating Valganciclovir HCl in both bulk and dosage forms. Its validation parameters affirm the method's efficacy and robustness, which are critical for quality control in pharmaceutical applications. This study highlights the need for accessible analytical techniques that ensure the maintenance of pharmaceutical standards, ultimately contributing to better healthcare outcomes through improved drug monitoring. The proposed method holds promise for widespread use in laboratory settings for the routine analysis of Valganciclovir, given its demonstrated convenience and precision.
FAQ section (important questions/answers):
What is the purpose of the study described in the text?
The study aimed to develop and validate a simple, accurate, and cost-effective UV-Spectrophotometric method for estimating Valganciclovir HCl in bulk and pharmaceutical dosage forms as per ICH guidelines.
What is Valganciclovir and its primary application?
Valganciclovir is a prodrug of ganciclovir, primarily used as an anti-HIV drug that inhibits the replication of human cytomegalovirus (CMV), especially in infected cells.
What solvent was used for the UV-Spectrophotometric method?
0.1N HCl was chosen as the solvent for developing the UV-Spectrophotometric method for estimating Valganciclovir HCl due to its effectiveness in dissolving the drug.
What are the key validation parameters featured in the study?
The study validated the method based on linearity, accuracy, precision, robustness, ruggedness, LOD, and LOQ, confirming its reliability and consistency in measuring Valganciclovir HCl.
What was the λmax value found for Valganciclovir?
The absorption maxima (λmax) for Valganciclovir was established at 250 nm during UV spectrophotometric analysis, indicating the optimal wavelength for measurement.
How effective was the method according to the recovery results?
The method demonstrated high accuracy with recovery rates between 98.00% to 101.4%, confirming its effectiveness for routine analysis of Valganciclovir in pharmaceutical formulations.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “New spectroscopic method for estimating valgancyclovir HCl.”. 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:
Table refers to the organized arrangement of data in rows and columns, facilitating easy interpretation of analytical results. In the context of scientific research, tables summarize key findings, such as validation parameters and assay results, allowing for comparison and analysis of the data in a structured format, enhancing clarity and understanding.
2) Drug:
The term drug denotes chemical substances that can alter physiological functions when administered. In this study, Valganciclovir is examined for its pharmacological efficacy as an anti-HIV agent. Understanding a drug’s composition, mechanism of action, and therapeutic uses is fundamental in pharmaceutical research and quality control.
3) Science (Scientific):
Scientific denotes an approach based on evidence, systematic investigation, and adherence to methodological rigor. The research exemplifies scientific inquiry by applying validated methods for drug estimation, thus establishing reliability, reproducibility, and integrity in pharmaceutical studies and applications.
4) Study (Studying):
The word study reflects a focused investigation aimed at understanding or elucidating specific phenomena. In context, this study presents the development and validation of a novel UV-spectrophotometric method for estimating Valganciclovir in pharmaceutical formulations, contributing valuable insights to pharmaceutical analytical methodologies.
5) India:
India is significant in pharmaceutical research and development due to its vast market and manufacturing capabilities. The study was conducted in India, emphasizing the importance of developing reliable and cost-effective analytical methods like UV-spectrophotometry, which directly supports the quality assurance of pharmaceutical products.
6) Kumar (Kumār):
Kumar, the surname of one of the authors, denotes an individual's contribution to the research. It highlights the collaborative nature of scientific inquiry, acknowledging that individuals like Sathish Kumar Konidala play an essential role in advancing methodologies and sharing knowledge in the pharmaceutical field.
7) Water:
Water is a widely used solvent in the preparation of pharmaceutical solutions due to its universal solubility profile. In this study, water aids in dissolving Valganciclovir for analysis, demonstrating the significance of solvent selection in analytical procedures, ensuring that optimal solubility conditions are met.
8) Siddhartha (Siddhārtha, Siddhārthā, Siddha-artha):
Siddhartha refers to the Siddhartha Institute of Pharmaceutical Sciences, where the research was conducted. Such institutions are pivotal in advancing pharmaceutical technology and education, providing a platform for innovative research, training future scientists, and implementing new methodologies that ensure drug quality and safety.
9) Activity:
Activity relates to the pharmacological effect exerted by a drug. The study assesses Valganciclovir's antiviral activity, crucial for its role in treating viral infections. Understanding a drug's activity is essential for clinicians and researchers alike in developing effective therapeutic regimens and ensuring treatment efficacy.
10) Quality:
Quality pertains to the standard of the pharmaceutical product, which must meet specific criteria for safety, efficacy, and reliability. The validation of the UV-spectrophotometric method discussed in the study ensures that Valganciclovir formulations maintain high quality, essential for patient safety and therapeutic effectiveness.
11) Tulasi (Tulasī):
Tulasi, another author of the study, showcases the collaborative efforts inherent in scientific research. Authors contribute varying expertise, with each individual's insights and findings enriching the collective understanding of methodologies and results, contributing to the robust outcomes presented in the study.
12) Measurement:
Measurement is the process of obtaining quantitative data about a substance's properties. In the context of this research, it refers to the accurate quantification of Valganciclovir using UV spectrophotometry, ensuring that pharmaceutical formulations are within specified limits for dosage and efficacy.
13) Discussion:
Discussion entails the analysis and interpretation of findings within the research. It provides context for the results, such as the validation of the UV-spectrophotometric method, explaining its relevance to existing methodologies, potential implications in the field, and suggestions for future research avenues.
14) Developing:
Developing signifies the process of creating or improving methodologies or products. In this study, developing a UV-spectrophotometric method illustrates the continual effort in pharmaceutical research to enhance accuracy, efficiency, and cost-effectiveness in drug analysis, impacting both research and industry practices.
15) Lakshmi (Lakṣmī):
Lakshmi, a contributor to the research, highlights the diverse expertise of the author team. Individual researchers, such as Lakshmi Sai Tulasi, provide unique perspectives and skills that enhance the study's comprehensive analysis and methodological advancements in the field of pharmaceutical analysis.
16) Chandra:
Chandra signifies an individual, potentially part of the research team, emphasizing the collaborative nature of scientific work. Each contributor brings different expertise, which collectively aids in achieving the study's goals, ranging from method development to validation and assessment of pharmaceutical quality.
17) Meeting:
Meeting in a scientific context often refers to collaborative gatherings where researchers share findings, discuss methodologies, and exchange knowledge. These interactions are key for fostering innovation and improving analytical methods, directly contributing to effective solutions in pharmaceutical analysis.
18) Surface:
Surface relates to the physical interaction of pharmaceutical compounds with their environment. In analytical chemistry, understanding the properties of surfaces can influence methodologies such as HPLC, and physical properties, highlighting the importance of surface interactions in formulation and analysis of drug products.
19) Mishra (Miśra):
Mishra, a name among the contributors, reiterates the significance of teamwork in scientific research. Acknowledging individual researchers like Mishra reflects the collaborative process of discovery and method development that drives advancements in fields related to pharmaceutical analysis and methodology.
20) Girija (Giri-ja):
Girija represents a contributor to the research, showcasing the diverse backgrounds of authors involved in scientific studies. Contributions from various researchers like Girija Sankar enhance the comprehensive understanding of methodologies, particularly in developing reliable and valid analytical techniques in the pharmaceutical field.
21) Yamini (Yāminī, Yāmiṉi):
Yamini signifies another researcher involved in the study, showing that various individuals' expertise contributes to the overall research quality. Each author, including Yamini Sai Silpa, plays a critical role in the study, emphasizing the importance of teamwork in scientific advancements and discoveries.
22) Dasari:
Dasari alludes to one of the contributors, denoting the necessity of collaboration in research efforts. Authors like Dasari emphasize the collective input required to advance methodologies, ascertain results, and propose innovations within the pharmaceutical analysis discipline.
23) Purity:
Purity in pharmacology signifies the absence of contamination and the presence of the active ingredient at specified concentrations. Ensuring the purity of Valganciclovir is essential for solution efficacy and safety, impacting patient health. This measure is crucial in pharmaceutical analysis protocols.
24) Powder:
Powder refers to the physical state of a drug when it is formulated for analysis. In the study, Valganciclovir was measured after converting it to a powdered form for accurate quantitative analysis, highlighting the importance of appropriate sample preparation in ensuring reliable results.
25) Saxena (Sakshena, Saksena):
Saxena represents another contributor to the published study, reinforcing the collaborative aspects of scientific research. The involvement of researchers like Saxena illustrates the varied contributions of skills and expertise required to achieve comprehensive outcomes in pharmaceutical research.
26) Durga (Durgā, Dur-ga):
Durga reflects the multidimensional authorship of the research. The collaboration among several contributors, including figures such as Durga Devi, demonstrates the global synthesis of knowledge and the collective effort required to drive forward advancements in drug analysis methodologies.
27) Omkara (Oṃkāra, Oṅkāra, Onkar, Omkar, Onkara, Om-kara):
Onkar, a name among the contributors, shows the importance of collaboration in science. Researchers like Onkar Singh contribute diverse insights that enhance analytical methodologies, ensuring comprehensive validation processes that uphold the quality standards essential in pharmaceutical product evaluation.
28) Devi (Devī):
Devi, associated with one of the authors, underscores the significant role of individual researchers in advancing scientific discourse. Contributions from authors, including Tulasi Durga Devi, highlight dimensions of diversity and collective effort necessary for delivering innovative research outcomes.
29) Babu (Bābū):
Babu refers to a contributor and embodies the collaborative spirit of scientific research. Authors like Babu Rao Chandu unify diverse knowledge bases and proficiencies, fostering an enriched environment for developing methodologies that improve analysis quality in pharmaceuticals.
30) Life:
Life, in the scientific context, often pertains to the biological implications of drugs and therapeutic agents. Valganciclovir's efficacy impacts aspects of life by treating viral infections, illustrating how pharmaceutical developments contribute to enhancing the quality of life through effective medical interventions.
31) Viru (Vīṟu):
Viru symbolizes the virucidal effectiveness of the studied drug, Valganciclovir, against viral entities. Understanding its action against HIV provides insight into the drug's role in clinical applications, contributing substantially to therapeutic strategies aimed at combating viral diseases.
Other Science Concepts:
Discover the significance of concepts within the article: ‘New spectroscopic method for estimating valgancyclovir HCl.’. Further sources in the context of Science might help you critically compare this page with similair documents:
Statistical analysis, Solubility Test, Absorbance maxima, Correlation coefficient, Recovery study, Chemical structure, Limit of detection, Limit of quantification, Calibration curve, Limit of Detection (LOD), Limit of Quantification (LOQ), Sensitivity of the method, Method validation, Pharmaceutical dosage form, Validation Process.