RP-HPLC method for naftopidil analysis in bulk and dosage form.
Journal name: World Journal of Pharmaceutical Research
Original article title: Analytical method development and validation of naftopidil in bulk and dosage form using rp hplc
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.
Summary of article contents:
Introduction
This article presents a study on the development and validation of an analytical method for the estimation of Naftopidil, a drug utilized predominantly for treating lower urinary tract symptoms due to benign prostatic hyperplasia (BPH). The method employs Reversed Phase High Performance Liquid Chromatography (RP-HPLC) for the precise identification and quantification of Naftopidil in both bulk and dosage forms. The study outlines the methodology, chromatographic conditions, validation parameters, and the results obtained, showcasing the reliability and efficacy of the proposed analytical technique.
Analytical Method Development
The RP-HPLC method developed for quantifying Naftopidil involved separating the drug using a C18 column with a mobile phase composed of Potassium Dihydrogen Phosphate and Acetonitrile in a 35:65 ratio, at a flow rate of 1.0 ml/min. The detection of Naftopidil was conducted at 232 nm using a UV detector. The limits of detection (LOD) and quantitation (LOQ) for Naftopidil were determined to be 0.094 μg/ml and 0.28 μg/ml, respectively. The method showed a linear response for Naftopidil in the range of 0.5-10 μg/ml, demonstrating its accuracy and efficiency for routine analysis.
Validation Parameters
The validation of the analytical method adhered to International Conference on Harmonisation (ICH) guidelines, evaluating its accuracy, precision, specificity, and robustness. The accuracy was confirmed through recovery studies, with a mean recovery of 100.8% indicating high reliability. Precision was assessed through repeatability (with a relative standard deviation of 0.74%), intra-day (0.28%), and inter-day (0.30%) evaluations, all satisfying the acceptance criteria below 2% RSD. This rigorous validation confirms the method's reproducibility and suitability for analytical purposes.
Importance of Robustness and Ruggedness
The robustness of the RP-HPLC method was tested by altering flow rates and oven temperatures, ensuring no significant differences in results, thus validating its reliability under varied experimental conditions. Ruggedness was assessed by having different analysts perform the same method with overlapping results, further proving that the analytical technique is not significantly affected by variations in operators. This characteristic is essential in quality control laboratories where methods should be consistently executed by different personnel.
Conclusion
In conclusion, the RP-HPLC method developed for the analysis of Naftopidil is straightforward, accurate, and reproducible, making it a suitable choice for routine pharmaceutical analysis. The method demonstrates excellent linearity within the specified concentration range and has been extensively validated according to established guidelines. These features affirm its applicability in both research and quality control settings for pharmaceutical products containing Naftopidil.
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.
Shruti Bika, Prashant Purohit and Yoshita Aggarwal
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: Analytical method development and validation of naftopidil in bulk and dosage form using rp hplc
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
Doi: 10.20959/wjpr201710-9362
Download the PDF file of the original publication
FAQ section (important questions/answers):
What is the purpose of the developed HPLC method?
The developed HPLC method is designed for the estimation of Naftopidil in bulk and dosage forms, ensuring accuracy and reliability for routine analysis.
What is the mobile phase composition for Naftopidil estimation?
The mobile phase consists of Potassium Dihydrogen o-phosphate and Acetonitrile in a ratio of 35:65, providing optimal conditions for Naftopidil separation.
What are the limits of detection and quantitation for Naftopidil?
The limit of detection (LOD) for Naftopidil is 0.094 µg/ml, while the limit of quantitation (LOQ) is 0.287 µg/ml, indicating high method sensitivity.
How was the accuracy of the method validated?
Accuracy was validated through recovery studies, with results showing a mean recovery of 100.8%, confirming the method's reliability in measuring Naftopidil.
What were the findings related to method precision?
Precision studies indicated low %RSD values for repeatability, intra-day, and inter-day tests, all below 2%, indicating high reproducibility of the method.
How was the method's robustness assessed?
Robustness was tested by varying flow rate and oven temperature, with results demonstrating no significant differences, confirming the method's reliability under different conditions.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “RP-HPLC method for naftopidil analysis in bulk and dosage form.”. 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 research provides a clear and organized format for presenting data, making it easily accessible for interpretation. In this context, tables summarize complex information, such as calibration data, results of analytical methods, and statistical analyses, facilitating comparisons and discussions about findings related to Naftopidil's performance in HPLC studies.
2) Drug:
The term 'drug' refers to a chemical substance used to diagnose, cure, treat, or prevent diseases; here, it specifically pertains to Naftopidil, an alpha1-adrenergic receptor antagonist. Understanding its properties, efficacy, and methods of analysis are crucial for ensuring effective treatments for conditions like benign prostatic hyperplasia.
3) Observation:
Observation involves systematically noting and recording phenomena or results, which is fundamental in scientific research. In this study, careful observation during HPLC analysis ensured accurate results regarding Naftopidil's concentration and behavior under varying conditions, contributing to the validation of the analytical method's reliability and robustness.
4) Discussion:
Discussion is a critical component of research where findings are analyzed, interpreted, and contextualized with existing knowledge. This section evaluates how the results of Naftopidil’s analysis compare with previous studies, the implications for clinical use, and possible areas for future research, ensuring a comprehensive understanding of the drug's performance.
5) India:
India is the geographical and cultural backdrop of the study, impacting pharmaceutical research and development practices. The availability of local resources, regulatory frameworks, and educational institutions in India, specifically in Rajasthan, enhance the research capabilities, especially at institutions like Rajasthan Pharmacy College, where this study was conducted.
6) Study (Studying):
A study refers to a systematic investigation to establish facts or principles. This research focuses on developing and validating an HPLC method for Naftopidil. The findings provide valuable insights into analytical techniques that enhance drug quality assurance and regulatory compliance in pharmaceutical industries.
7) Performance:
Performance refers to how well the HPLC method accurately measures Naftopidil within the established guidelines and parameters. Evaluating performance involves analyzing sensitivity, precision, and reproducibility, which are crucial for ensuring the method provides reliable and valid results for quality control in pharmaceutical formulations.
8) Quality:
Quality in pharmaceutical contexts refers to the degree to which a product meets established standards and specifications for safety, efficacy, and purity. The study emphasizes the importance of developing reliable analytical methods like HPLC to maintain high quality in drug production, ensuring patients receive effective therapies.
9) Jaipur:
Jaipur is the capital city of Rajasthan, India, and is relevant because it is home to the Rajasthan Pharmacy College, where the research was conducted. The city's infrastructure, educational resources, and access to pharmaceutical industries support academic and practical advancements in the field of pharmacy and drug research.
10) Water:
Water, particularly Milli-Q water in this study, is essential as a solvent in HPLC. Its purity is crucial for avoiding contamination that could skew results. Using high-quality water ensures accurate measurements and reliable reproducibility in the method development and validation phases of the research.
11) Rajasthan:
Rajasthan, as the state where the research was performed, plays a key role in the pharmaceutical education and industry landscape in India. It hosts numerous educational institutions and pharmaceutical companies, facilitating advancements in drug development, quality assurance, and the application of analytical methods like HPLC.
12) Shruti (Sruti):
Shruti refers to Shruti Bika, the corresponding author of the study, whose expertise in quality assurance and pharmaceutical research significantly contributes to the methodology and reliability of this work. Individual researchers are important for driving scientific endeavors, producing quality research, and mentoring students in pharmaceutical sciences.
13) Measurement:
Measurement in the context of this study pertains to quantifying the concentration of Naftopidil using HPLC. Accurate measurement is critical for determining the drug's potency and efficacy, ensuring that pharmaceutical products meet safety and effectiveness standards that are vital for patient health outcomes.
14) Activity:
Activity in pharmaceutical research often refers to the pharmacological effects or actions of a drug. In this study, analyzing the activity of Naftopidil involves understanding how the drug interacts with its target receptors, impacting both its therapeutic effects and potential side effects in treating lower urinary tract symptoms.
15) Relative:
Relative often refers to how something compares or is connected to something else. In pharmaceutical studies, relative standard deviation (RSD) indicates reproducibility of results; a lower RSD demonstrates that an analytical method can consistently produce similar results across multiple trials, assuring the method's reliability for quality control.
16) Filling (Filled):
Filled might refer to the process of formulation in pharmaceuticals, where active ingredients like Naftopidil are integrated into dosages like tablets or capsules. This process is vital to ensure consistent dosing and effective release of the drug into the patient's system, essential for therapeutic effectiveness.
17) Blood:
Blood is relevant in pharmacology as it often serves as the medium through which a drug acts within the body. Understanding how drugs like Naftopidil interact with blood components can provide insights into their pharmacokinetics and pharmacodynamics, influencing therapeutic strategies in treating related conditions.