RP-HPLC method for estimating rosuvastatin in bulk and tablets.
Journal name: World Journal of Pharmaceutical Research
Original article title: Rp-hplc method development for estimation of rosuvastatin in bulk and 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.
This page presents a generated summary with additional references; See source (below) for actual content.
Original source:
This page is merely a summary which is automatically generated hence you should visit the source to read the original article which includes the author, publication date, notes and references.
Prajakta Aher
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: Rp-hplc method development for estimation of rosuvastatin in bulk and tablet dosage form
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
Doi: 10.20959/wjpr202313-29239
Download the PDF file of the original publication
Summary of article contents:
Introduction
Rosuvastatin is a pharmacological agent used primarily to manage cholesterol levels and prevent cardiovascular diseases. It is classified as a statin and operates by inhibiting the enzyme HMG-CoA reductase, crucial for cholesterol synthesis in the liver. This study focuses on the development and validation of a Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method for accurately quantifying rosuvastatin in both bulk and tablet forms. The research detailed within aims to provide a reliable analytical method suitable for routine quality control in pharmaceutical applications.
Method Development and Validation
The newly developed RP-HPLC method employed a mobile phase consisting of acetonitrile and water in a ratio of 75:25 (v/v), which effectively separated rosuvastatin using a Water spherisorb C18 column. The method demonstrated a retention time of 3.097 minutes and was optimized for linearity over a concentration range of 5-40 μg/mL with a correlation coefficient of 0.999. Recovery studies indicated excellent accuracy, with percent recoveries ranging from 99.5% to 100.4%. Furthermore, the method's precision was showcased, with a relative standard deviation (RSD) of less than 2.0%, confirming its reliability for analytical purposes.
Specificity and Sensitivity
The specificity of the RP-HPLC method was assessed by examining potential interferences from excipients present in the tablet formulations. The study successfully demonstrated that there was no interference, confirming the method's high specificity. In terms of sensitivity, the limits of detection (LOD) and quantification (LOQ) were calculated to be 0.017 μg/mL and 0.052 μg/mL, respectively. These findings highlight the method's capability to accurately measure low concentrations of rosuvastatin, further validating its suitability for quality control in pharmaceutical formulations.
Robustness and System Suitability
The robustness of the RP-HPLC method was tested with minor variations in chromatographic parameters, such as mobile phase composition, flow rate, and wavelength detection. The results showed negligible changes in chromatographic performance, reinforcing the method's robustness. System suitability tests were conducted using standard solutions, resulting in high theoretical plates (4590) and a tailing factor of 1.1, indicative of good peak shape and resolution. These parameters collectively affirmed that the developed method performs adequately for intended analyses.
Conclusion
The RP-HPLC method established for the estimation of rosuvastatin offers a rapid, precise, and accurate approach for quantifying this compound in pharmaceutical formulations. Its straightforward nature, low solvent consumption, and minimal analytical time contribute to environmentally friendly practices within the laboratory setting. Overall, this method can be effectively employed for routine quality control in the industry, ensuring the consistency and efficacy of rosuvastatin products in the market.
FAQ section (important questions/answers):
What is the purpose of the RP-HPLC method developed?
The RP-HPLC method was developed to accurately estimate rosuvastatin in bulk and tablet dosage forms, providing an efficient and sensitive analysis suitable for routine quality control in the pharmaceutical industry.
What were the main results of the method validation?
The method showed a retention time of 3.097 minutes, a correlation coefficient (r²) of 0.999, and recovery percentages between 99.5% to 100.4%, indicating high accuracy and precision in the analysis of rosuvastatin.
What is the composition of the mobile phase used?
The mobile phase consisted of acetonitrile and water in a 75:25 v/v ratio, which was optimized to achieve a clear chromatogram with good resolution during the RP-HPLC analysis.
What instruments were used in the study?
The study used a Shimadzu liquid chromatographic system, Waters HPLC pump, auto sampler, and a photodiode array detector, controlled by Empower software to carry out the chromatographic analysis.
What were the limits of detection and quantification achieved?
The limit of detection (LOD) was 0.017 µg/ml and the limit of quantification (LOQ) was 0.052 µg/ml, indicating the method's high sensitivity for rosuvastatin quantification.
Can the method be used for routine quality control?
Yes, the developed RP-HPLC method is accurate, precise, and efficient, making it ideal for routine quality control and analysis of rosuvastatin in its tablet formulations.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “RP-HPLC method for estimating rosuvastatin in bulk and 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) Table:
Table refers to a systematic arrangement of data, often in rows and columns, to facilitate easy comparison, analysis, and understanding. In scientific research, tables summarize results such as method validation parameters, recovery studies, and linearity data, presenting them succinctly to enhance clarity and support conclusions drawn from the analysis.
2) Water:
Waters in this research context refers to Waters Corporation, a company that manufactures analytical instruments and technologies, including HPLC systems. Their equipment was utilized in the study, indicating the reliance on advanced technology for method development and validation, thus enhancing the credibility and reproducibility of the analytical results.
3) Drug:
Drugs are substances used for medical purposes, and in this study, rosuvastatin is the primary focus. The exploration of drugs emphasizes the importance of developing precise analytical methods for their quantification and characterization, which is essential in ensuring therapeutic efficacy, safety, and regulatory compliance within pharmaceutical practices.
4) Maharashtra (Maharastra, Maha-rashtra):
Maharashtra is a state in western India known for its significant contribution to various sectors, including pharmaceuticals. The research was conducted in Ahmednagar, Maharashtra, indicating the region's involvement in pharmaceutical research and its role in developing analytical methods that could impact the industry and public health positively.
5) Ahmednagar:
Ahmednagar is a city in Maharashtra, India, and the site where the research was carried out. It signifies local contributions to pharmaceutical science, showcasing the efforts of educational institutions in training professionals and advancing methodologies such as the RP-HPLC method for quality control and drug analysis in the region.
6) Performance:
Performance in this context refers to the efficiency and effectiveness of the analytical method used for estimating rosuvastatin. It encompasses parameters like retention time, resolution, and reproducibility, highlighting how well the method can separate and quantify the drug in a mixture,which is essential for reliable results in quality control.
7) Discussion:
Discussion refers to the section of the research where findings are interpreted and compared to prior studies. This critical examination allows for the contextualization of results, evaluation of the method’s advantages and limitations, and suggestions for future research, thus fostering a deeper understanding of the analytical method’s impact.
8) Relative:
The Relative in a scientific context often refers to relative measurements or comparisons between various data points. In this study, it is associated with relative standard deviation, allowing researchers to express the precision and reliability of their analytical results as a percentage, which is critical for method validation.
9) Powder:
Powder is a physical form of substances, often used as a dosage form in pharmaceuticals. The tablets investigated were ground into powder to create a sample solution for analysis, emphasizing the importance of accurate measurement and preparation in obtaining consistent results when quantifying the active pharmaceutical ingredient.
10) India:
India is the country where this research takes place, showcasing its growing pharmaceutical industry and the increasing need for quality control methods for drug analysis. The study highlights the importance of developing robust analytical techniques to ensure medication efficacy and safety, contributing to broader public health initiatives.
11) Study (Studying):
Study refers to the systematic investigation undertaken to evaluate the RP-HPLC method for estimating rosuvastatin. It signifies the research process, highlighting the design, execution, validation, and analysis of data to draw reliable conclusions. The findings can influence future research and pharmaceutical practices aimed at improving drug quality and safety.
12) Measurement:
Measurement is the process of obtaining a quantitative value or assessment. In this study, it is crucial for determining concentration levels, peak areas, and drug recovery rates, allowing researchers to validate the performance of the developed analytical method and ensuring that results meet predetermined accuracy and precision standards.
13) Disease:
Disease represents a specific pathological condition that the drug rosuvastatin aims to treat, primarily hyperlipidemia and cardiovascular diseases. The emphasis on disease underscores the critical role of pharmaceuticals in public health and the need for effective monitoring and therapeutic solutions that improve patient outcomes.
14) Quality:
Quality refers to the standard of the pharmaceutical product and the analytical methods used to assess its efficacy and safety. In the context of this research, ensuring the quality of rosuvastatin through rigorous method validation is crucial to maintain consumer trust and comply with regulatory requirements in the pharmaceutical industry.
15) Family:
Family in this context relates to the classification of drugs, such as statins, which share a common mechanism of action in lowering cholesterol. Understanding the family of drugs is crucial for healthcare providers to make informed decisions regarding treatment plans and educate patients about their therapeutic options and potential effects.
16) Diet:
Diet refers to the intake of food and its importance in managing health conditions, particularly in conjunction with medications like rosuvastatin. The mention of diet suggests a holistic approach to treatment, as lifestyle modifications play a critical role in the overall effectiveness of drugs in preventing or treating diseases.
Other Science Concepts:
Discover the significance of concepts within the article: ‘RP-HPLC method for estimating rosuvastatin in bulk and tablets.’. Further sources in the context of Science might help you critically compare this page with similair documents:
Correlation coefficient, Limit of detection, Limit of quantification, HPLC Method, Calibration curve, Percentage recovery, Method validation, Tablet dosage form, Chromatographic condition, Cholesterol biosynthesis.