HPTLC method for zolpidem estimation in pharmaceuticals.
Journal name: World Journal of Pharmaceutical Research
Original article title: Development and validation of hptlc method for estimation of zolpidem in pharmaceutical 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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Deepali A. Bansode, and K.R.Mahadik, Principal
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: Development and validation of hptlc method for estimation of zolpidem in pharmaceutical dosage forms
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
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Summary of article contents:
Introduction
This study focuses on the development and validation of a High-Performance Thin-Layer Chromatography (HPTLC) method for the estimation of zolpidem in both bulk and pharmaceutical dosage forms. Zolpidem is classified as a nonbenzodiazepine hypnotic that acts on the GABA receptors, primarily used for the treatment of insomnia. The method proposed in this paper addresses the need for a reliable, cost-effective technique for routine analysis, improving on existing methods by ensuring high precision and accuracy without interference from excipients.
Chromatographic Method Development
The chromatographic separation was performed on aluminum plates pre-coated with silica gel as the stationary phase, using a mobile phase of water, methanol, and acetic acid. The densitometric quantification of zolpidem was performed at a wavelength of 245 nm, yielding a consistent Rf value of 0.42±0.03. The method demonstrated linearity across a concentration range of 100-1000 ng/spot, along with impressive accuracy and precision, with intra-day and inter-day relative standard deviations (RSDs) of 0.52% and 0.91%, respectively. These findings confirm that the proposed method fits the criteria set by the International Council for Harmonisation (ICH) guidelines.
Method Validation and Performance
The developed HPTLC method was rigorously validated for several key parameters, including accuracy, limit of detection (LOD), limit of quantification (LOQ), specificity, precision, and robustness. Accuracy was confirmed through recovery studies, yielding results ranging from 99.12% to 100.10% at varying concentration levels. LOD was determined to be 10 ng/spot, while LOQ was found to be 30 ng/spot. Specificity tests confirmed that the method could effectively separate zolpidem from excipients in tablet formulations. Furthermore, robustness testing indicated that slight variations in method parameters did not significantly affect the results.
Practical Application in Pharmaceutical Analysis
The validated HPTLC method was also applied to the analysis of marketed zolpidem tablets, notably ZOLDEM, which contains a label claim of 5 mg/tablet. The extraction method employed included sonication and careful dilution, enabling effective quantification of zolpidem content. The capacity for precise and rapid analysis makes this method particularly valuable for quality control in pharmaceutical laboratories, where both speed and economy are prioritized.
Conclusion
The study successfully developed and validated a new HPTLC method for the estimation of zolpidem, demonstrating its simplicity, accuracy, and reproducibility. The method not only adheres to ICH guidelines but also offers a practical alternative for routine analytical procedures in pharmaceutical settings. With its reliable performance and economic advantages, this method holds significant potential for widespread use in determining the quality of zolpidem in various dosage forms.
FAQ section (important questions/answers):
What is the objective of the HPTLC method for zolpidem estimation?
The objective is to develop a simple, precise, accurate, and specific HPTLC method to estimate zolpidem both as a bulk drug and in tablet dosage forms.
What mobile phase was used in the HPTLC method for zolpidem?
The mobile phase consisted of water, methanol, and acetic acid in a ratio of 8.0:2.7:0.3 (v/v/v), which provided good resolution for zolpidem.
How was the method validated according to ICH guidelines?
The method was validated for linearity, accuracy, precision, limit of detection, limit of quantification, repeatability, specificity, and robustness following ICH guidelines.
What were the findings regarding the accuracy of the HPTLC method?
The recovery studies indicated an accuracy range of 99.12% to 100.10%, confirming the method's reliability for estimating zolpidem in tablet dosage forms.
What was the limit of detection and quantitation found for zolpidem?
The limit of detection (LOD) was found to be 10 ng/spot, while the limit of quantitation (LOQ) was identified as 30 ng/spot for zolpidem.
What advantages does the developed HPTLC method offer?
The developed method is simple, economical, rapid, precise, and specific, making it suitable for routine analysis in pharmaceutical quality-control laboratories.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “HPTLC method for zolpidem estimation in pharmaceuticals.”. 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 substances that are utilized for medical treatment, particularly therapeutic agents like zolpidem. In the context of the study, it highlights the focus on pharmaceutical analysis for accuracy, precision, and validation of the compound's efficacy and safety in therapeutic applications.
2) Table:
The term 'Table' specifically relates to the format commonly used to present data systematically. In the context of the study, tables are used for presenting results, such as precision data, recovery percentages, and calibration curves, allowing for easier comparison and understanding of analytical outcomes.
3) Water:
In this research, 'Water' is a key solvent in the mobile phase for HPTLC method. Its role is crucial as it aids in the dissolution of zolpidem, contributing to the separation process. It impacts the efficiency and effectiveness of chromatographic techniques in drug analysis.
4) Relative:
'Relative' is often used to describe measurements in relation to other standards or samples. In the study, it might refer to relative standard deviation, emphasizing the consistency and reliability of experimental results compared to established benchmarks, hence ensuring that findings are meaningful.
5) India:
The keyword 'India' establishes the geographical and contextual framework of the study. It signifies the location where the research was conducted and where the pharmaceutical analyses are relevant, reflecting local practices, regulations, and significance of drug standardization in Indian pharmaceutical sciences.
6) Noise:
'Noise' in the context of analytical methods refers to undesired fluctuations in data that can obscure true signals. In HPTLC studies, a signal-to-noise ratio assessment ensures that the detected signal from zolpidem is distinguishable from background noise, ensuring accurate quantification.
7) Measurement:
The term 'Measurement' is fundamental in scientific research, involving quantifying variables like concentration or purity. In the context of this study, accurate measurement of zolpidem is essential, underpinning the development of a reliable HPTLC method to ensure consistency and validation of results.
8) Powder:
'Powder' refers to the form in which zolpidem is often handled or analyzed, especially in tablet dosage forms. Understanding the characteristics and extraction of zolpidem in powder form is essential for method development, influencing solubility and efficiency during the chromatographic process.
9) Study (Studying):
The keyword 'Study' denotes the systematic investigation described in the text. It involves the development, validation, and application of the HPTLC method for zolpidem estimation. The study's outcomes contribute essential knowledge to pharmaceutical analysis and drug quality assurance.
10) Maharashtra (Maharastra, Maha-rashtra):
'Maharashtra' is a significant region in India where the study took place. Identifying this location provides context regarding the local pharmaceutical industry, regulatory standards, and educational institutions involved, which is critical to understanding the relevance and applicability of the research findings.
11) Bharati:
'Bharati' relates to Bharati Vidyapeeth University, a notable institution involved in pharmaceutical education and research in India. This affiliation suggests the academic and professional standards of the research, emphasizing its relevance in the context of higher education and scientific inquiry in pharmaceuticals.
12) Purity:
'Purity' is a crucial parameter in pharmaceutical analysis, indicating the absence of contaminants or impurities in a drug. In this study, the purity of zolpidem is essential for ensuring accurate dosage and therapeutic effectiveness, making its assessment fundamental to quality control processes.
13) Poona:
'Poona' is a historical name for Pune, indicating the geographic and cultural context of the research location. It highlights the importance of local institutions in advancing pharmaceutical sciences, ensuring that regional characteristics and standards inform the development and validation of analytical methods.
14) Glass:
'Glass' in this study likely refers to laboratory equipment made of glass, such as beakers or chromatography chambers. It is important for conducting experiments due to its chemical resistance and inert nature, ensuring that reactions and measurements are not contaminated by the container material.
15) Pune:
'Pune' is significant as the city where Bharati Vidyapeeth University is located. Its mention denotes the research's roots in an educational environment promoting pharmaceutical sciences, highlighting the role of local academic institutions in contributing to drug development and quality assurance practices.
16) Hair:
'Hair' may reference analytical techniques used in detecting zolpidem in biological samples, indicating forensic or clinical relevance. The presence of zolpidem in hair samples is relevant for studies on substance use, requiring reliable methods like HPTLC for accurate detection and quantification.
17) Purification:
'Purification' pertains to methods employed to achieve the highest quality of zolpidem by removing impurities. In pharmaceutical contexts, effective purification processes ensure that the drug's efficacy is maximized while its safety is confirmed, essential in quality control and regulatory compliance.
18) Performance:
The keyword 'Performance' describes the effectiveness and efficiency of the HPTLC method developed in the study. Evaluating the performance parameters ensures that the method is suitable for routine analysis, reliable, and capable of meeting industry standards for pharmaceutical quality control.
19) Reliability:
'Reliability' is a cornerstone of this research, indicating the consistency of the HPTLC method in accurately estimating zolpidem concentrations. Establishing reliability through validation protocols ensures that the method can be trusted for regulatory purposes and routine application in laboratories.
20) Discussion:
'Discussion' typically refers to a section in research papers where the implications of results are analyzed. This study's discussion would evaluate findings in relation to existing literature, emphasizing how the new HPTLC method enhances knowledge in zolpidem quantification and pharmaceutical analysis.
21) Knowledge:
'Knowledge' encompasses the information gained through scientific research. In this study, the knowledge derived from developing a reliable HPTLC method enhances understanding of zolpidem analysis, serving as a valuable resource for other researchers and practitioners in pharmaceuticals aiming for consistent quality assurance.
22) Quality:
'Quality' in pharmaceutical contexts relates to the degree of excellence of a drug, ensuring safety, efficacy, and consistency. The study emphasizes the establishment of quality through rigorous methodologies, essential for maintaining the standards necessary for therapeutic agents like zolpidem.
23) Reason:
'Reason' suggests causality or justification within the research context. It points to the underlying motivations for developing the HPTLC method for zolpidem, such as improving analytical accuracy in pharmaceuticals, which is vital for addressing regulatory expectations and patient safety.
24) Blood:
'Blood' could refer to the matrix in which zolpidem might be analyzed for pharmacokinetic studies. It's important for understanding how zolpidem is distributed in the body, where reliable analytical methods, like HPTLC, can provide critical data for safety and efficacy evaluations in therapeutic use.
25) Lamp:
'Lamp' refers to the light source used in analytical techniques such as HPTLC. The deuterium lamp is crucial for providing the necessary UV light for detecting zolpidem, making it an essential component in the instrumentation that enhances the sensitivity and accuracy of the measurements made.
Other Science Concepts:
Discover the significance of concepts within the article: ‘HPTLC method for zolpidem estimation in pharmaceuticals.’. Further sources in the context of Science might help you critically compare this page with similair documents:
High performance liquid chromatography, Mobile phase, Densitogram, Quality control laboratories, Chromatographic separation, Limit of detection, Linearity range, Liquid chromatography-tandem mass spectrometry, Method development, HPTLC method, Calibration curve, Limit of Detection (LOD), Analytical Procedure, Chemical formula, Pharmaceutical formulation, Recovery studies, Method validation, Sample stability, Pharmaceutical dosage form, Limit of quantitation, Tablet dosage form, Stationary phase, Relative standard deviation, Hypnotic effect, Specificity of the method, Silica Gel, Biological fluid.