RP-HPLC method for simultaneous estimation of dutasteride and tamsulosin.
Journal name: World Journal of Pharmaceutical Research
Original article title: Method development and validation for the simultaneous estimation of dutasteride and tamsulosin hydrochloride in pharmaceutical dosage forms by 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.
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Jahnavi Bandla, Gorja Ashok
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: Method development and validation for the simultaneous estimation of dutasteride and tamsulosin hydrochloride in pharmaceutical dosage forms by rp-hplc
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
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Summary of article contents:
Introduction
Dutasteride and Tamsulosin hydrochloride are two pharmaceutical compounds commonly used in the treatment of benign prostatic hyperplasia (BPH). Dutasteride functions as a dual 5-alpha reductase inhibitor, reducing the conversion of testosterone to dihydrotestosterone, thus aiding in the management of BPH symptoms. Tamsulosin, in contrast, is an alpha-1a blocker that specifically targets receptor sites to alleviate difficulties in urination associated with an enlarged prostate. This article presents the development and validation of a rapid, accurate, and precise method for the simultaneous estimation of both drugs in pharmaceutical dosage forms using reverse-phase high-performance liquid chromatography (RP-HPLC).
Method Development and Validation
An effective RP-HPLC method was formulated utilizing an Xterra-symmetry C18 column under isocratic conditions with a mobile phase comprising phosphate buffer (at pH 2.5) and acetonitrile in a 20:80 (%v/v) ratio. The analysis was carried out at a flow rate of 0.8 mL/min, with UV detection at 274 nm. The retention times for Dutasteride and Tamsulosin hydrochloride were established as 2.0 and 5.0 minutes, respectively. The method's optimization was rigorously validated according to the International Conference on Harmonization (ICH) guidelines, demonstrating a linear response across specified concentration ranges and high recovery percentages.
System Suitability and Specificity
System suitability tests were performed to ensure the precision of the method. Five injections of a standard solution yielded values for USP plate count and USP tailing, affirming that the system was functioning optimally. Specificity assessments confirmed that there were no interfering substances when injecting placebo and standard solutions. This ensures that the method could accurately isolate and quantify Dutasteride and Tamsulosin hydrochloride without interference from other components in pharmaceutical formulations.
Results of Validation Parameters
The validation study encompassed various parameters, including linearity, accuracy, precision, ruggedness, robustness, limit of detection (LOD), and limit of quantitation (LOQ). The method displayed excellent linearity for both drugs within the range of 25 to 125 µg/mL, with a correlation coefficient of 0.999. Recovery tests revealed values closely approximating 100% for both compounds, indicating the method's accuracy. Moreover, low relative standard deviation (RSD) values (0.42 for Dutasteride and 0.45 for Tamsulosin hydrochloride) evidenced the method's precision, while robust findings ensured the method's reliability under varied operational conditions.
Conclusion
In conclusion, the developed RP-HPLC method provides a feasible, accurate, and efficient means for the simultaneous estimation of Dutasteride and Tamsulosin hydrochloride in pharmaceutical forms. This method not only meets ICH validation standards but also presents a valuable tool for routine quality control in pharmaceutical settings. The ability to reliably quantify both drugs supports their effective monitoring in formulations, ultimately contributing to improved therapeutic outcomes for patients suffering from BPH.
FAQ section (important questions/answers):
What is the primary aim of the developed RP-HPLC method?
The method aims to provide a simple, rapid, accurate, and precise way to simultaneously estimate Dutasteride and Tamsulosin hydrochloride in pharmaceutical dosage forms.
What are the key components of the mobile phase used?
The mobile phase consists of a mixture of phosphate buffer (pH 2.5) and acetonitrile in a 20:80 v/v ratio, allowing effective separation in the RP-HPLC method.
How are the limits of detection determined in this study?
Limits of detection (LOD) and quantification (LOQ) were calculated based on the standard deviation and slope of the regression equation, yielding LOD values of 5.9 µg/mL for Dutasteride and 6.2 µg/mL for Tamsulosin.
What parameters were analyzed to validate the HPLC method?
The method was validated for parameters including accuracy, precision, specificity, robustness, ruggedness, linearity, and limits of detection and quantification, following ICH guidelines.
What were the retention times for the drugs in the method?
In the RP-HPLC method, the retention time was 2.0 minutes for Dutasteride and 5.0 minutes for Tamsulosin hydrochloride, indicating effective separation.
What are the potential applications of the developed method?
The developed method can be used for routine quality control analysis of pharmaceutical samples containing Dutasteride and Tamsulosin hydrochloride, ensuring consistent drug quality.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “RP-HPLC method for simultaneous estimation of dutasteride and tamsulosin.”. 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 term 'Drug' refers to a chemical substance used for the diagnosis, treatment, or prevention of disease. In the context of this study, Dutasteride and Tamsulosin hydrochloride are the primary drugs being analyzed for their efficacy, safety, and concentration in pharmaceutical formulations, highlighting their significance in medical treatments, particularly for benign prostatic hyperplasia.
2) Bandla:
'Bandla' refers to Jahnavi Bandla, the lead author of the research article. The inclusion of an author's name signifies the individual or group responsible for the study, contributing to the research community's knowledge and facilitating further investigations into pharmaceuticals and analytical methods, particularly regarding drug estimation techniques.
3) India:
'India' is the country where the research was conducted, specifically at the Gland Institute of Pharmaceutical Sciences. The geographical context is significant as it reflects the local pharmaceutical research landscape and the availability of resources and expertise for developing and validating analytical methods for drugs used in the region.
4) Table:
'Table' in this context refers to a structured presentation of data, often used in scientific literature to summarize findings concisely. Tables provide clarity to research results, enabling readers to easily compare parameters like retention times, recoveries, and system suitability, which are critical for validating the analytical method.
5) Science (Scientific):
'Science' represents the systematic study of the structure and behavior of the physical and natural world through observation and experimentation. This research falls under pharmaceutical science, contributing to the understanding of drug interactions and analysis methods, ultimately supporting the development of effective therapies and healthcare solutions.
6) Andhra (Āndhra, Amdhra):
'Andhra' refers to the state of Andhra Pradesh in India, where the research institution is located. Mentioning regional context highlights the institutional support and relevance of local pharmaceutical research initiatives aimed at improving healthcare outcomes in the area, including the validation of drug analysis methodologies.
7) Water:
'Water' is mentioned among the reagents used in the analytical process and is an essential solvent in pharmaceuticals. The quality of water is crucial in drug formulation and analysis, as it can influence the solubility and stability of compounds, thus impacting the accuracy of the estimated concentrations in HPLC methodologies.
8) Medak (Meḍak):
'Medak' is the district in Andhra Pradesh, India, where the Gland Institute of Pharmaceutical Sciences is based. The geographical locality plays a role in understanding the research environment and available expertise in pharmaceutical analysis, reinforcing the study's regional significance and its contribution to local healthcare practices.
9) Discussion:
'Discussion' is a key section in research where authors interpret results, explain implications, and relate findings to existing literature. In this study, the discussion would elaborate on the significance of the developed RP-HPLC method in the context of drug analysis, addressing its reliability and applications in pharmaceutical quality control.
10) Quality:
'Quality' refers to the standards of excellence achieved in the analysis and formulation of pharmaceutical products. In the context of this study, maintaining high quality in drug estimation methods is vital for ensuring patient safety and efficacy of treatments, emphasizing the importance of validation protocols outlined in regulatory guidelines.
11) Powder:
'Powder' refers to the physical form of a drug in this study, particularly in the context of preparing sample solutions from tablets. The transition from solid to liquid form is critical in analytical chemistry, as it allows for accurate quantification in methods like HPLC, ensuring effective drug analysis in pharmaceuticals.
12) Desire:
'Desire' is mentioned regarding the potential side effects associated with Dutasteride, particularly the psychological aspect of decreased sexual desire. This highlights the importance of understanding the pharmacological profile of drugs, ensuring that practitioners are aware of adverse effects for informed decision-making in patient treatment and healthcare management.
Other Science Concepts:
Discover the significance of concepts within the article: ‘RP-HPLC method for simultaneous estimation of dutasteride and tamsulosin.’. Further sources in the context of Science might help you critically compare this page with similair documents:
Resolution, Analytical method, Accuracy, Research article, Retention time, Correlation coefficient, Chromatographic separation, Limit of detection, Limit of quantification, Method development, Limit of Detection (LOD), Specificity, RP-HPLC Method, Flow rate, Method validation, Pharmaceutical dosage form, Precision, Limit of quantitation, Standard solution, Experimental, Regression equation, ICH Guideline.