HPTLC method for simultaneous analysis of paracetamol and ondansetron
Journal name: World Journal of Pharmaceutical Research
Original article title: Development and validation of a normal-phase hptlc method for the simultaneous analysis of paracetamol and ondansetron in fixed-dose tablets
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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Vasubabu Padarthi, Dr. K. N. Vidyadhar, K. Shalini, M. Harika, K.S.G. Sravanthi and M. Keerthana
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: Development and validation of a normal-phase hptlc method for the simultaneous analysis of paracetamol and ondansetron in fixed-dose tablets
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
Doi: 10.20959/wjpr201611-7160
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Summary of article contents:
Introduction
The study presented in this article focuses on the development and validation of a high-performance thin-layer chromatography (HPTLC) method for the simultaneous analysis of two important pharmaceutical compounds: paracetamol and ondansetron. Conducted by Vasubabu Padarthi and colleagues at V.J’S College of Pharmacy, the research aims to establish a reliable and efficient method for quantifying these drugs in fixed-dose tablet formulations. Both paracetamol and ondansetron are widely used in clinical settings, with paracetamol functioning primarily as a pain reliever and ondansetron as an antiemetic.
Development of the HPTLC Method
The researchers utilized a mobile phase composed of chloroform, dichloromethane, and methanol in a specific ratio (4:6:2) to achieve effective separation of paracetamol and ondansetron on pre-coated silica gel plates (TLC silica gel 60 F254). The method was quantified using densitometric absorbance at 254 nm. The retention factors (Rf) for ondansetron and paracetamol were determined to be 0.69 and 0.61, respectively. Additionally, the method demonstrated a linear concentration range of 1-5 µg/spot for both compounds, alongside established limits of detection and quantification for each drug.
Method Validation
To ensure the reliability and accuracy of the HPTLC method, validation was performed in accordance with International Conference on Harmonization (ICH) guidelines. Key parameters assessed included precision, accuracy, recovery, and linearity. The results indicated high precision with relative standard deviations (RSDs) below 2%, while the mean recoveries for both drugs were found to be within the acceptable range of 97% - 103%. This validation process confirms the method's capability to achieve accurate results for paracetamol and ondansetron in their respective formulations.
Application in Pharmaceutical Analysis
The validated HPTLC method was successfully applied to analyze fixed dosage tablets (specifically, Lupisetron plus from Lupin Ltd), which contained paracetamol and ondansetron. Assay results indicated that the percentage purity for paracetamol ranged from 99.533% to 100.0117%, and for ondansetron from 99.057% to 100.815%. This application demonstrates the method's practical utility in quality control processes, enabling efficient assessment of active pharmaceutical ingredients in combination therapies.
Conclusion
In conclusion, the study highlights the successful development and validation of an HPTLC method for the simultaneous estimation of paracetamol and ondansetron. The method's simplicity, high selectivity, and accuracy make it a valuable tool for pharmaceutical analysis. The research contributes to the existing knowledge base by providing a novel HPTLC approach for quantifying these compounds in tablet formulations, thereby supporting stringent quality assurance in the pharmaceutical industry.
FAQ section (important questions/answers):
What is the main purpose of this study?
The study developed and validated a high-performance thin-layer chromatography (HPTLC) method for the simultaneous analysis of paracetamol and ondansetron in fixed-dose tablets.
What are the key findings about the HPTLC method?
The HPTLC method demonstrated good linearity, precision, and recovery for both drugs, with an R² value of 0.999 and recovery percentages between 99.103% and 101.2573%.
What are paracetamol and ondansetron used for?
Paracetamol is used as an analgesic and antipyretic, while ondansetron is used mainly for preventing nausea and vomiting associated with chemotherapy or radiotherapy.
What was the mobile phase used in the HPTLC method?
The mobile phase consisted of chloroform, dichloromethane, and methanol in a ratio of 4:6:2.
How was the accuracy of the HPTLC method assessed?
Accuracy was evaluated through recovery studies, by comparing the determined concentration of spiked samples to the theoretical concentrations.
What are the implications of this study’s findings?
The validated HPTLC method provides a reliable and efficient approach for analyzing paracetamol and ondansetron in pharmaceutical formulations, which is beneficial for quality control.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “HPTLC method for simultaneous analysis of paracetamol 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) Table:
In the context of this study, a 'Table' refers to a structured representation of data or results. Tables are essential in conveying quantitative findings, such as concentration levels, peak areas, and assay results in a clear format, enabling easy comparison and interpretation of the analytical data obtained through the HPTLC method.
2) Drug:
A 'Drug' is a substance used for therapeutic purposes to diagnose, cure, treat, or prevent diseases. In this study, Paracetamol and Ondansetron are the primary drugs analyzed, highlighting their significance in managing pain and nausea, which is essential for effective patient care in clinical practices.
3) Methane:
In the text, 'Methane' is one component of the mobile phase utilized in the HPTLC analysis. Although primarily known as a greenhouse gas, in analytical chemistry, such solvents play an essential role in separating and analyzing compounds. Methane's inclusion aids in achieving the desired chromatographic separation needed for accurate measurements.
4) Purity:
'Purity' in pharmaceutical terms denotes the degree to which a drug contains its stated active ingredient without contamination. In this study, purity is quantitatively assessed to ensure that the analyzed tablets meet the required standards, confirming the reliability and efficacy of the drugs for patients.
5) Rheumatoid arthritis:
Rheumatoid arthritis is an autoimmune disorder characterized by chronic inflammation of joints, causing pain and disability. The reference to this condition underscores Paracetamol's pharmacological role in managing mild to moderate pain but emphasizes its limitations, as it does not reduce inflammation compared to other anti-inflammatory drugs.
6) Radiotherapy:
'Radiotherapy' is a cancer treatment using high doses of radiation to kill or slow cancer cell growth. The inclusion of this term in the text relates to Ondansetron's application as an antiemetic medication to prevent nausea and vomiting that may be induced by radiotherapy during cancer treatment.
7) Inflammation:
Inflammation is a biological response to harmful stimuli, such as pathogens or injuries. The relationship between Paracetamol's mechanism and its anti-inflammatory capabilities is discussed, highlighting its role in reducing inflammation indirectly. This understanding is critical for healthcare professionals when choosing appropriate medications for their patients.
8) Performance:
'Performance' in this context refers to the efficiency and effectiveness of the analytical method developed. The precision, accuracy, and reliability of the HPTLC technique are evaluated based on its performance metrics, which are essential for establishing a standardized method for simultaneous drug analysis in pharmaceutical formulations.
9) Puducherry:
'Puducherry' is mentioned as the location of the Institution from which the drugs were sourced. This geographical reference is important as it indicates the origin of the research materials and points to the need for local pharmaceutical access, highlighting India’s role in drug research and development.
10) Discussion:
'Discussion' refers to the section of the study where results are interpreted and contextualized within existing literature. This part synthesizes findings and contrasts them with previous studies, helping clarify the implications of the results, which is crucial for understanding the significance of the method developed.
11) Vomiting:
'Vomiting' is a physiological reaction that can occur as a side effect of various medical treatments, especially chemotherapy. The relevance of this term lies in Ondansetron's role as an antiemetic, which effectively mitigates this symptom, making it an essential drug for improving the quality of life in patients undergoing treatment.
12) India:
'India' as a keyword indicates the geographical and cultural context of the study. It reflects the healthcare landscape in the country and its capabilities in pharmaceutical research. The mention emphasizes the importance of developing reliable analytical methods for local drug production and quality assurance.
13) Study (Studying):
'Study' refers to the scientific investigation presented in the text, aimed at developing and validating an analytical method for drug analysis. It encapsulates the research's breadth, methodology, results, and conclusions, providing a structured approach to understanding and evaluating pharmaceutical formulations effectively.
14) Noise:
'Noise' in the context of method validation refers to the interference affecting the signal in analytical measurements. It is crucial to establish the limit of detection and quantification, as low noise levels indicate a more accurate and reliable analytical method, essential for the validity of the results obtained.
15) Lamp:
'Lamp' commonly refers to the light source used in densitometric scanning during the analytical process. In this work, a deuterium lamp is specified, which is significant as it provides the necessary wavelengths for accurate detection of the analyzed compounds, ensuring that the measurements are precise and reliable.