HPLC method for simultaneous determination of paracetamol and domperidone.
Journal name: World Journal of Pharmaceutical Research
Original article title: Analytical method for the simultaneous determination of paracetamol and domperidone by h.p.l.c.
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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Sheeraz Ahmad Wagay, S.S.Ajay, Sudhanshu Dhar Dwivedi and Suryakant Barkhe
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: Analytical method for the simultaneous determination of paracetamol and domperidone by h.p.l.c.
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
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Summary of article contents:
1) Introduction
The study focuses on the development of a High-Performance Liquid Chromatography (HPLC) method to simultaneously determine the concentrations of Paracetamol and Domperidone, two commonly used pharmaceutical compounds. Paracetamol, known chemically as N-(4-hydroxy phenyl) acetamide, is widely used as an analgesic and antipyretic, while Domperidone, characterized as 1,3-dihydro-5-chloro-1-(1-(3-(2,3-dihydro-2-oxo-1H-benzimidazole-1-yl)propyl)-4-piperidinyl)-2H-benzimidazole-2-one, is primarily used to treat nausea and vomiting. The proposed HPLC method addresses the need for a simple, efficient, and accurate way to analyze these drugs within a single formulation.
2) Method Development and Parameters
The developed HPLC method utilizes a C18 column with a mobile phase composed of 35% acetate buffer and 65% methanol. The chromatographic conditions were carefully tuned, employing a flow rate of 1.0 mL per minute and a UV detection wavelength of 280 nm. Key parameters such as retention time, precision, and recovery were evaluated to ensure the reliability of the method. The retention times observed for Paracetamol and Domperidone were 3.284 minutes and 13.662 minutes, respectively, showcasing effective separation and detection of both compounds in the proposed method.
3) Validation of the Method
Validation studies illustrated the reliability of the HPLC method. Precision was assessed by calculating the percentage relative standard deviation (%RSD), which was reported to be below 0.42%, indicating high reproducibility in the measurements. Recovery tests were performed at varying concentrations, resulting in recovery percentages between 98% and 102%, thereby confirming the accuracy and specificity of the method. The study also established a linear correlation for both compounds, with a correlation coefficient close to 1.0, demonstrating excellent detection capability throughout the specified ranges for both drugs.
4) Application to Commercial Tablet Formulations
The validated HPLC method was applied to commercial formulations, specifically Domcet tablets. Using an average weight of the tablets, the powdered samples were analyzed to determine the drug content of Paracetamol and Domperidone through comparison with standard solutions of known concentrations. The study highlighted the applicability and effectiveness of the method in analyzing real-world pharmaceutical products, further affirming its potential use in routine quality control processes within pharmaceutical laboratories.
5) Conclusion
In conclusion, the proposed HPLC method for the simultaneous estimation of Paracetamol and Domperidone in pharmaceutical formulations has demonstrated its specificity, accuracy, precision, and efficiency. The method offers a robust tool for routine quality control of oral dosage forms containing these two active pharmaceutical ingredients. This advancement not only enhances the reliability of testing but also contributes to improved patient safety and therapeutic efficacy in the use of these medications.
FAQ section (important questions/answers):
What is the purpose of this study on Paracetamol and Domperidone?
The study aims to develop a simple, precise, rapid, and accurate reverse phase HPLC method for the simultaneous estimation of Paracetamol and Domperidone in pharmaceutical dosage forms.
What chromatography technique was used in this research?
The research utilized High Performance Liquid Chromatography (HPLC) with a reverse phase chromatography method on a C18 column, ensuring the separation of Paracetamol and Domperidone from a single formulation.
What concentration ranges were established for the drugs in the study?
The linear working range for Paracetamol was 700 to 1500 ppm, and for Domperidone, it was 14 to 30 ppm, allowing accurate quantification and comparison with standard values.
How was the specificity of the method verified?
The specificity was checked by injecting placebo solutions and verifying that they did not interfere with the retention times of Paracetamol and Domperidone, ensuring the method's reliability.
What were the recovery rates observed in the study?
The percentage recovery of both drugs was found to be between 98% and 102%, demonstrating the accuracy and reliability of the developed HPLC method.
What are the main findings regarding precision in this study?
The % RSD for both drugs was less than 0.42%, indicating high precision in the HPLC analysis, which is crucial for routine quality control.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “HPLC method for simultaneous determination of paracetamol and domperidone.”. 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:
In the context of this research, 'drug' refers to pharmacologically active compounds, specifically Paracetamol and Domperidone. These are utilized in medication formulations. Understanding their accurate measurement is crucial for ensuring safety and efficacy when in combination for therapeutic use. Thus, it plays a vital role in pharmaceutical analysis.
2) Species:
The term 'species' here pertains to chemical entities, particularly the closely related compounds of Paracetamol and Domperidone. Effective separation and quantification of these species in pharmaceutical formulations is essential for the analytical method employed, ensuring precise dosing and minimizing potential drug interactions in patients.
3) Substance:
'Substance' denotes any particular matter, including drugs, that has characteristics used for analysis in the study. In this research, it refers specifically to the active ingredients being analyzed. The accurate determination of each substance ensures effective treatment outcomes and assists in quality control during pharmaceutical production.
4) Powder:
'Powder' refers to the form in which the tablet formulation of the drugs was analyzed. The tablets were crushed into a fine powder to prepare solutions for HPLC analysis. This step is essential for ensuring uniform dissolution of the drug substances, allowing for accurate measurement during the chromatography process.
5) Water:
In this research, 'water' appears as a solvent component crucial for preparing aqueous buffers. HPLC requires high-purity water to avoid contamination that could interfere with the separation and detection of drug substances. The quality of water impacts analytical results and thus is critical for accurate pharmaceutical assessments.
6) Study (Studying):
'Study' refers to this specific research investigation focusing on developing an analytical method for the simultaneous determination of two drugs using HPLC. It outlines methods, materials, results, and conclusions that contribute to improving pharmaceutical analysis and quality control, facilitating better healthcare outcomes for patients.
7) Performance:
'Performance' in this text pertains to the efficiency and effectiveness of the HPLC method used for analyzing Paracetamol and Domperidone. Key performance indicators, such as precision, accuracy, and sensitivity, are evaluated to ensure the analytical method is suitable for routine quality control in pharmaceutical applications.
8) Discussion:
'Discussion' refers to the section of the study where the results are interpreted and implications of the findings are considered. This part provides insights into the effectiveness and potential limitations of the developed method, drawing conclusions that relate to its applicability in broader pharmaceutical contexts.
9) Quality:
'Quality' in this context concerns the standards of the pharmaceutical formulations being analyzed, specifically looking at the accuracy and precision of the analytical method developed. Ensuring high quality in drug products is vital for patient safety, therapeutic effectiveness, and regulatory compliance in the pharmaceutical industry.
10) Science (Scientific):
'Science' denotes the systematic study of knowledge, including methodologies used, like HPLC, to analyze drug formulations. It embodies the principles and practices applied in pharmaceutical research to ensure that methods are reliable, reproducible, and aligned with scientific standards to meet safety and efficacy requirements.
11) Nature:
'Nature' can refer to the inherent properties of substances being analyzed, such as their chemical and physical characteristics. In this context, understanding the nature of Paracetamol and Domperidone aids in optimizing the conditions for their analysis, ensuring accurate measurement and identification when present together in formulations.
12) India:
'India' represents the geographical context of the research, indicating where the analysis was conducted. The regulatory and pharmaceutical landscape of India has implications for the drug development process and quality control, affecting public health initiatives and the availability of medicines for the population.
13) Dhar:
'Dhar' refers to one of the authors of the research, highlighting contributions from specific individuals in the scientific study. The recognition of individual researchers underscores collaborative efforts in advancing pharmaceutical sciences and reflects the diverse backgrounds and expertise involved in developing effective analytical methodologies.
14) Line:
'Line' refers to the graphical representation in the context of 'linearity'. It indicates the relationship between concentration and detector response. This relationship is established during method validation to ensure the analytical method's reliability in quantifying active drug substances effectively when developing pharmaceutical products.
15) Salt (Salty):
'Salt' in the context likely refers to Ammonium acetate used in buffer preparation during the HPLC analysis. Salts are critical in chromatography for maintaining pH and ionic strength, which influences the separation of substances, ensuring accurate and reproducible results in drug analysis.
Other Science Concepts:
Discover the significance of concepts within the article: ‘HPLC method for simultaneous determination of paracetamol and domperidone.’. Further sources in the context of Science might help you critically compare this page with similair documents:
Analytical method, High performance liquid chromatography, Retention time, Mobile phase, Recovery studies, Quantitative determination, Chromatographic condition, Detection limit, Commercial Samples.