UV method development for simultaneous estimation of ranitidine and ondansetron.
Journal name: World Journal of Pharmaceutical Research
Original article title: Development and validation of uv spectrophotometric method for the simultaneous estimation of ranitidine and ondansetron in bulk and pharmacutical formulation
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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Vaibhav R. Mandale, Dr. Subhash S. Palekar, Dr. Prakash T. Sangale, Dr. Tauqueer Kadu, Dr. Atul S. Sayare, Archana M. Karnik.
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Full text available for: Development and validation of uv spectrophotometric method for the simultaneous estimation of ranitidine and ondansetron in bulk and pharmacutical formulation
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 UV spectrophotometric method for the simultaneous estimation of Ranitidine (RAN) and Ondansetron (OND) in injection dosage forms. Ranitidine is an H2-receptor antagonist used for treating conditions like gastric ulcers, while Ondansetron acts as a selective 5-HT3 receptor antagonist effective in preventing chemotherapy-induced nausea and vomiting. The combination of these two medications enhances therapeutic outcomes without causing adverse pharmacokinetic interactions. The research demonstrates a novel spectrophotometric method due to the lack of previously reported simultaneous analysis techniques for these drugs in combined pharmaceutical formulations.
Method Development and Optimization
The UV spectrophotometric method was finely tuned to determine the maximum absorption wavelengths (λmax) for both RAN and OND, which were discovered to be 230 nm and 216 nm, respectively. The method was tested within specific concentration ranges, achieving linearity for RAN (50-200 μg/ml) and OND (8-32 μg/ml). Calibration curves indicated a strong linear relationship, evidenced by high coefficients of determination (r² values of 0.9999 and 0.9998 for RAN and OND, respectively). Additionally, validation of the method was performed according to ICH guidelines, establishing it as a credible means of quantifying these medications in their pharmaceutical form.
Accuracy and Precision Validation
Validation of the UV spectrophotometric method included assessments of accuracy and precision. The accuracy was evaluated through recovery studies, where standard solutions for both RAN and OND were added to a sample at various concentrations (80%, 100%, and 120%). Precision was calculated both intra-day and inter-day, demonstrating high consistent results with relative standard deviations (RSD) below 1%. The limits of detection (LOD) and limits of quantification (LOQ) established for RAN were 0.454 μg/ml and 0.151 μg/ml respectively, while for OND, these values were 0.657 μg/ml and 2.18 μg/ml. These results suggest that the method is not only accurate but also reliable for routine analysis.
Applications of the Developed Method
The proposed method is characterized by its simplicity, sensitivity, and reproducibility, making it suitable for the routine analysis of RAN and OND in pharmaceutical preparations. The study specifically highlights the effectiveness of this method in analyzing commercial formulations, ensuring that accurate measurements can be obtained quickly. The statistical analyses resulting from the evaluations confer confidence in the practicality of this UV spectrophotometric approach for the simultaneous estimation of these two drugs, benefiting quality control in pharmaceutical settings.
Conclusion
In conclusion, the developed UV spectrophotometric method for the simultaneous determination of Ranitidine and Ondansetron represents a significant advancement in pharmaceutical analysis. Its validation through a series of rigorous tests confirms its accuracy, precision, and robustness, making it a valuable tool for routine analysis of these medications in injection formulations. The study provides a foundation for future research and applications in drug analysis, ensuring the efficacy and safety of combined pharmaceutical therapies aimed at alleviating the side effects of cancer treatments.
FAQ section (important questions/answers):
What is the purpose of this UV spectrophotometric method?
The method was developed for the simultaneous estimation of Ranitidine and Ondansetron in injection dosage form, ensuring accurate, specific, and precise measurement.
What were the maximum wavelengths for Ranitidine and Ondansetron?
The maximum wavelength (λmax) for Ranitidine was found to be 230 nm, while for Ondansetron, it was 216 nm.
What was the linearity range for the drugs in this study?
The linearity range was 50-200 μg/ml for Ranitidine and 8-32 μg/ml for Ondansetron, showing a strong linear relationship.
How was the accuracy of this method validated?
Accuracy was validated through recovery studies by adding known quantities of drugs to a placebo and comparing actual to measured concentrations.
What are LOD and LOQ values for Ranitidine and Ondansetron?
The limit of detection (LOD) was 0.454 μg/ml for Ranitidine and 0.657 μg/ml for Ondansetron, while the limit of quantitation (LOQ) was 0.151 μg/ml and 2.18 μg/ml respectively.
Who provided the samples for this research study?
The authors received Ranitidine and Ondansetron samples as gifts from Ranbaxy Laboratories Ltd, enhancing the study's reliability and resource availability.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “UV method development for simultaneous estimation of ranitidine and ondansetron.”. 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' in this context refers to pharmacological substances, specifically Ranitidine and Ondansetron, which are studied for their efficacy in treating conditions like nausea and vomiting associated with chemotherapy, as well as gastric ulcers. The combined dosage form is highlighted for its therapeutic benefits.
2) India:
India is relevant here as it is the geographic location where the research was conducted, specifically in a pharmaceutical context. The collaboration with Ranbaxy Laboratories, a significant pharmaceutical company in India, indicates the importance of local resources and expertise in the validation of the UV spectrophotometric method.
3) Study (Studying):
The study described is a scientific investigation aimed at developing and validating a UV spectrophotometric method for the simultaneous estimation of Ranitidine and Ondansetron. It addresses a gap in existing methodologies and contributes to improving analytical techniques in pharmaceutical formulations.
4) Table:
Tables in this document present critical data, such as analysis results of the injection dosage forms and validation parameters for the drugs tested. They help in summarizing findings and making them accessible for comparison and further analysis, enhancing the clarity of experimental results.
5) Pune:
Pune is the city where the research institution, JSPM’s Rajarshi Shahu College of Pharmacy & Research, is located. This city's educational and pharmaceutical environment contributes to the development of new analytical methods and the training of future professionals in pharmaceutical sciences.
6) Maharashtra (Maharastra, Maha-rashtra):
Maharashtra is the Indian state where Pune is situated. The state's significance lies in its robust pharmaceutical industry and academic institutions, which foster innovation and research in drug formulation and analysis, making it a vital hub for pharmaceutical research in India.
7) Rajarishi (Rajarsi, Rajarshi, Rajarisi):
Rajarshi refers to Rajarshi Shahu College of Pharmacy & Research, which is integral to the research presented. The institution plays a pivotal role in shaping pharmacy education and research initiatives, contributing to the industry's development and the training of skilled professionals in pharmaceutical sciences.
8) Quality:
Quality, in this context, pertains to the assurance of accuracy and reliability in pharmaceutical analyses. The study emphasizes the need for quality control in the simultaneous estimation of drugs, adhering to guidelines to ensure methods are robust, reproducible, and acceptable in a regulatory environment.
9) Nausea:
Nausea is one of the primary symptoms targeted by Ondansetron, a drug used to prevent vomiting. In the study, it is highlighted in the context of chemotherapy, where patients often experience nausea, thus necessitating effective treatments to improve their quality of life.
10) Deva:
Deva refers to Devas, a region in Madhya Pradesh, India, where Ranbaxy Laboratories is located. The company supplied the drug samples, playing a crucial role in ensuring that the study was conducted with authentic and high-quality materials, contributing to the legitimacy of the research.
11) Chemotherapy:
Chemotherapy is a medical treatment often associated with cancer management. This study highlights Ranitidine and Ondansetron's roles in mitigating chemotherapy-induced nausea and vomiting, thus addressing significant quality-of-life issues for patients undergoing cancer treatment, emphasizing the drugs' therapeutic importance.
12) Vomiting:
Vomiting is a distressing symptom commonly experienced by patients undergoing chemotherapy. Ondansetron's formulation aims to control this side effect, which is crucial for maintaining patients' well-being during treatment, underscoring the research's focus on improving patient care through effective drug combinations.
13) Relative:
Relative refers to the parameters used in statistical analyses within the study, such as the relative standard deviation (RSD). It is indicative of the method's precision and reliability, contributing to the credibility of the findings and the validity of the developed analytical technique.
14) Cancer:
Cancer is the underlying medical condition addressed by the drug combination of Ranitidine and Ondansetron. The study is significant as it contributes to the understanding of how these medications can alleviate some of the adverse effects of chemotherapy, a common treatment for cancer patients.
15) Ulcer:
Ulcer refers to gastric ulcers, which can affect cancer patients and necessitate treatment. Ranitidine, an H2-receptor antagonist, is included in the study to highlight how the drug can be beneficial in managing gastric acid-related issues that may arise in the context of cancer care.
16) Kadu:
Kadu refers to Dr. Tauqueer Kadu, one of the contributors to the research. His involvement, along with others mentioned, emphasizes the collaborative effort in academia, fostering a shared vision for advancing pharmaceutical research and education within the context of drug analysis.
17) Line:
Line indicates the linear relationship established between concentration and absorbance in the UV method. Establishing linearity is crucial for validating the analytical method, allowing for accurate quantification of Ranitidine and Ondansetron in various formulations in practical applications.
18) Discussion:
Discussion denotes the section of the research where results are interpreted and contextualized within the literature. It serves to connect findings with existing knowledge, addressing implications for future research and applications, including therapeutic advancements and analytical methodologies in pharma.
19) Ashlesha (Aslesa):
Ashlesha refers to Prof. Dr. Ashlesha P. Pandit, a key contributor in the research team. Her involvement underscores the collaborative nature of the study, highlighting the diverse expertise present in academia, which leads to comprehensive approaches in pharmaceutical research and development.
20) Madhya:
Madhya refers to Madhya Pradesh, the Indian state where Ranbaxy Laboratories is located. The state plays a significant role in the pharmaceutical industry, providing important infrastructure and resources that contribute to drug development and quality analysis, as evidenced in the research presented.
Other Science Concepts:
Discover the significance of concepts within the article: ‘UV method development for simultaneous estimation of ranitidine and ondansetron.’. Further sources in the context of Science might help you critically compare this page with similair documents:
Research work, Statistical analysis, Absorbance maxima, Recovery study, Limit of detection, Limit of quantification, Calibration curve, Analytical method validation, Intraday precision, Interday precision, Pharmaceutical formulation, Limit of quantitation, Linear Relationship, Relative standard deviation, Linear regression analysis, Routine Analysis, Drug Concentration, ICH Guideline, Authors acknowledgment.