UV-spectroscopy and RP-HPLC methods for abacavir and lamivudine.
Journal name: World Journal of Pharmaceutical Research
Original article title: Devlopment and validation of uv-spectroscopy and rp-hplc for simultaneous estimation of abacavir sulphate and lamivudine in tablet 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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Original source:
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Jyoti Patel, S. T. Patil and S. P. Pawar
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: Devlopment and validation of uv-spectroscopy and rp-hplc for simultaneous estimation of abacavir sulphate and lamivudine in tablet dosage form.
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
Doi: 10.20959/wjpr20175-8406
Download the PDF file of the original publication
Summary of article contents:
Introduction
The study focuses on the development and validation of a rapid and reliable analytical method using UV-spectroscopy and reverse phase high-performance liquid chromatography (RP-HPLC) for the simultaneous estimation of two antiretroviral drugs, Abacavir Sulphate and Lamivudine, in tablet dosage forms. The method employs a C18 column for chromatographic separation and utilizes a mobile phase of methanol and water (15:85) at a flow rate of 1 ml/min, with UV detection at 228 nm. The validation parameters adhered to ICH and USP guidelines, confirming the method's suitability for routine quality control analysis in pharmaceuticals.
Method Validation and Performance
The RP-HPLC method demonstrated excellent linearity for both Abacavir and Lamivudine, with calibration ranges of 10-50 µg/ml and 5-25 µg/ml, respectively. Validation included key parameters such as accuracy, precision, robustness, and system suitability tests. The limit of detection (LOD) was established at 0.598 µg/ml for both drugs, while the limit of quantification (LOQ) values were determined to be 8.163 µg/ml for Abacavir and 1.814 µg/ml for Lamivudine. These findings underline the method’s reliability and appropriateness for analyzing these drugs in routine quality checks.
Chromatographic Conditions and Results
The chromatographic setup included a C18 (250 × 4.6 mm, 5 µm) column and a mobile phase consisting of water (0.05% acidic acid) and methanol in the ratio of 85:15 (v/v) at a wavelength of 228 nm. A satisfactory separation between Adacavir and Lamivudine was achieved, with retention times of 7.38 minutes for Abacavir and 3.15 minutes for Lamivudine. The robustness of the method was also tested under varying conditions—such as changes in flow rate and mobile phase composition—demonstrating its reliability across different chromatography parameters.
Assessment of Drug Content
The proposed method allowed for accurate analysis of commercially available formulations of Abacavir and Lamivudine. Results from the assay of the tablet formulation (Abamune-L) showed high compliance with labeled claims for both drugs, with calculated result deviations (RSD values) remaining below 2%, indicating a high level of accuracy. This confirms the method's potential for use in determining the content of these antiretroviral agents in pharmaceutical preparations.
Conclusion
In conclusion, the validated RP-HPLC method for the simultaneous estimation of Abacavir Sulphate and Lamivudine is efficient, accurate, and suitable for routine pharmaceutical analysis. The affordability and simplicity of the mobile phase formulation enhance its practicality in quality control settings. Given the validation parameters and strong correlation results, this method can confidently be applied in both research and clinical settings for ongoing drug analysis and bioequivalence studies.
FAQ section (important questions/answers):
What are the main drugs analyzed in this study?
The study analyzes Abacavir Sulphate and Lamivudine, which are synthetic nucleoside analogs used as antiretroviral drugs for HIV-1 treatment.
What method is used for simultaneous estimation of the drugs?
The study employs a validated RP-HPLC method for simultaneous estimation of Abacavir Sulphate and Lamivudine in tablet dosage forms.
What are the mobile phase constituents in the HPLC method?
The mobile phase consists of methanol and water in a ratio of 15:85, with 0.05% acidic acid added.
What were the limits of detection for the drugs tested?
The limit of detection for both Abacavir and Lamivudine was found to be 0.598 µg/ml.
What are the ranges for linearity of the drugs?
The linearity range for Abacavir was 10-50 µg/ml and for Lamivudine was 5-25 µg/ml.
What did the study conclude about the developed method?
The study concluded that the RP-HPLC method is rapid, simple, specific, and reliable for routine quality control analysis of Abacavir and Lamivudine.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “UV-spectroscopy and RP-HPLC methods for abacavir and lamivudine.”. 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:
In the context of the manuscript, 'Table' refers to a structured representation of data summarizing experimental results, methodologies, and validation parameters. Tables are crucial for organizing data in a clear and concise manner, allowing for easy comparison and analysis of results within the research on the simultaneous estimation of Abacavir and Lamivudine.
2) Patel:
'Patel' is the surname of the corresponding author of the study, Jyoti Patel. The significance of the author’s name indicates the contribution made by the researchers in developing the methodology for analyzing antiretroviral drugs. It also reflects the collaborative effort of the research team in addressing healthcare challenges.
3) Drug:
'Drug' is a term that refers to a substance used for medical treatment. In this study, it specifically pertains to Abacavir and Lamivudine, antiretroviral agents that are vital in the treatment of HIV-1. Understanding the characteristics and effectiveness of these drugs is essential for developing effective therapies for HIV/AIDS.
4) Study (Studying):
'Study' represents the research and experimental work conducted to validate a new high-performance liquid chromatography (HPLC) method for estimating the concentrations of Abacavir and Lamivudine. The outcomes of the study are critical for advancing pharmaceutical analysis and quality control processes in the industry and addressing public health needs.
5) Quality:
'Quality' refers to the standard of the drugs being analyzed, ensuring they meet specific efficacy and safety criteria. In pharmaceutical contexts, quality analysis is essential for regulatory compliance and for assuring healthcare professionals and patients that drug products are reliable and effective for treatment.
6) Water:
'Water' serves as a solvent component in the mobile phase of the chromatographic analysis for the HPLC method. Its purity and composition are critical to the effectiveness of the separation process. The use of high-purity water ensures accurate results in the quantification of the target drugs.
7) Maharashtra (Maharastra, Maha-rashtra):
'Maharashtra' is a state in India, indicating the geographical context of the research. It highlights the institutional affiliation of the researchers with P.S.G.V.P. Mandal's College of Pharmacy located in Maharashtra, showcasing contributions to pharmaceutical research and education from that region.
8) Performance:
'Performance' in this context pertains to the effectiveness and efficiency of the developed HPLC method in providing reliable and accurate estimations of the drug concentrations. Evaluating performance is crucial for ensuring the method can be reliably used in routine quality control in pharmaceutical applications.
9) Nandurbar:
'Nandurbar' is a district in Maharashtra where the research was conducted. Its mention signifies the local context within which the research was performed, highlighting regional efforts in pharmaceutical research that aim to address public health needs by improving drug analysis and quality control methods.
10) Training:
'Training' refers to the educational and skill development aspect provided by Shree Industrial Training Centre to the authors, enhancing their expertise in handling pharmaceuticals and analytical techniques. Such training is crucial for fostering competency in conducting high-quality research in the pharmaceutical field.
11) Jalgaon:
'Jalgaon' is a city in Maharashtra where Shree Industrial Training Centre is located. It emphasizes the regional collaboration in the research, indicating the influence of local institutions in advancing pharmaceutical sciences and supporting innovative research activities within the state.
12) Mandal:
'Mandal' in this context refers to the organization or institution, specifically P.S.G.V.P. Mandal's College of Pharmacy. This indicates the institution's role in supporting and facilitating research efforts, contributing to advancements in pharmaceutical knowledge and practice through education and research initiatives.
13) Purity:
'Purity' denotes the quality measure of the chemical substances being analyzed, specifically Abacavir and Lamivudine. Ensuring high purity levels in drug substances is paramount in pharmaceutical research, influencing both the reliability of analytical results and compliance with regulatory standards for drug safety and efficacy.
14) Shri (Sri, Sr):
'Shree' is often used as a respectful term in Indian culture, indicating honor or reverence. In this manuscript, it precedes 'Industrial Training Centre,' highlighting the importance of institutional support in the researchers' educational and professional journey in pharmaceutical development and analysis.
15) Reliability:
'Reliability' indicates the consistency and dependability of the HPLC method developed in the study. Establishing reliability is essential for ensuring that the method can be confidently used in routine quality control processes, providing accurate drug estimations for effective treatment regimens.
16) Discussion:
'Discussion' refers to the section in the manuscript where results, implications, and the significance of findings are analyzed. This part is critical for interpreting data, providing context for the results, and determining how the study contributes to the existing knowledge in pharmaceutical analysis and HIV treatment.
17) Relative:
'Relative' pertains to the comparison of measured parameters in relation to one another or to acceptable standards. In this research, it can refer to values such as the concentration of drugs found in samples compared to a target or expected value, which is vital for evaluating method performance.
18) Patil:
'Patil' is the surname of one of the co-authors, S. T. Patil. Mentioning the names of all authors acknowledges their collaborative effort in the research study, reflecting the diverse contributions made to the scientific work of developing and validating the analytical methods presented.
19) Viru:
'Viru' does not appear in the provided text context, making direct association challenging. If it were part of the research or authorship framework, it could have been an indication of another researcher or a related context in pharmaceutical or medical fields that might require further information.
Other Science Concepts:
Discover the significance of concepts within the article: ‘UV-spectroscopy and RP-HPLC methods for abacavir and lamivudine.’. Further sources in the context of Science might help you critically compare this page with similair documents:
Chromatographic separation, Recovery study, Limit of detection, Limit of quantification, Human immunodeficiency virus, Pharmaceutical formulation, Tablet dosage form, Chromatographic method.