Analytical method development and validation of olanzapine in formulated product
Journal name: World Journal of Pharmaceutical Research
Original article title: Analytical method development and validation of olanzapine in formulated product
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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Navya Khandelwal, Tapeesh Bharti, Chatrasal Singh Rajput and R P S Rathore
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: Analytical method development and validation of olanzapine in formulated product
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
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Summary of article contents:
Introduction
Olanzapine is an atypical antipsychotic medication used primarily for the treatment of schizophrenia and bipolar disorder. This study aimed to develop and validate a rapid and selective analytical method utilizing Reverse Phase Ultra Performance Liquid Chromatography (RP-UPLC) to analyze olanzapine in both raw materials and finished pharmaceutical products. The researchers sought to improve upon traditional High-Performance Liquid Chromatography (HPLC) methods, aiming for a process that is not only quicker but also requires less solvent, reduces costs, and enhances resolution and sensitivity.
Development of the UPLC Method
The analytical method developed employs a Waters Acquity BEH C18 column with dimensions of 50 × 2.1 mm and a particle size of 1.7μm. The mobile phase consists of a mixture of 0.1% trifluoroacetic acid (TFA) and acetonitrile in a gradient. The elution time for olanzapine was optimized to 3.5 minutes, allowing for effective separation and detection at a wavelength of 254 nm. The method exhibited excellent recovery rates, showing values between 96.74% and 101.35%. Importantly, the stability of the test solution was confirmed, remaining stable for up to 72 hours at room temperature.
Validation of Analytical Accuracy
The validation of the developed UPLC method adhered to guidelines set by the International Conference on Harmonization (ICH), focusing on critical parameters such as precision, accuracy, and linearity. The precision was assessed through repeated analyses of test samples, showing a relative standard deviation of 0.33%, which indicates high reproducibility. The accuracy results, derived from recovery studies, were impressive with values between 96.64% and 101.42%. Method linearity was confirmed across a range of concentrations, further validating the effectiveness of the developed analytical approach.
Method Robustness and Specificity
Robustness testing demonstrated that the UPLC method could withstand small modifications in operating conditions, such as flow rate and temperature variations, without significant impact on analytical performance. Specificity studies confirmed that there were no interferences from impurities, as indicated by the clarity of the chromatographic peaks for olanzapine while analyzing the test samples. This ability to distinctly identify the drug sets the method apart as both reliable and suitable for routine analysis in pharmaceutical quality control professions.
Conclusion
The newly developed RP-UPLC method offers a comprehensive solution for the effective analysis of olanzapine in pharmaceutical formulations. With its rapid elution times, solid accuracy, and robust operational parameters, this method stands out as a superior alternative to conventional HPLC techniques. The advancements presented in this study ensure that it can be effectively employed in pharmaceutical settings for quality control and related analyses, ultimately benefiting the efficiency of olanzapine's therapeutic applications.
FAQ section (important questions/answers):
What analytical method was developed for Olanzapine analysis?
A rapid and selective Reverse Phase Ultra Performance Liquid Chromatography (RP-UPLC) method was developed for analyzing Olanzapine in raw materials and pharmaceutical dosage forms.
What are the advantages of UPLC over traditional HPLC?
UPLC offers several advantages over HPLC, including faster analysis speed, improved resolution, lower solvent consumption, and reduced analysis costs.
What were the chromatographic conditions used in the study?
The conditions included a Water Acquity BEH C18 column, a mobile phase of 0.1% TFA and acetonitrile in an 80:20 ratio, and a flow rate of 0.6 ml/min.
How was the accuracy of the UPLC method validated?
Accuracy was validated using recovery studies at different concentration levels, with recoveries ranging from 96.74% to 101.35% across 50%, 100%, and 150% test levels.
What was the retention time for Olanzapine using this method?
The retention time for Olanzapine analyzed by the developed UPLC method was 1.86 minutes, allowing for quick batch testing.
What was concluded about the new UPLC method for Olanzapine?
The developed RP-UPLC method is simple, precise, accurate, robust, and rapid, ideal for quality control of Olanzapine in tablet formulations.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “Analytical method development and validation of olanzapine in formulated product”. 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) Water:
Water is a vital solvent used in the pharmaceutical industry, specifically in the preparation of buffer solutions and diluents. In this study, it was combined with acetonitrile in a 50:50 ratio for sample preparation, highlighting its role in facilitating the chromatographic analysis of olanzapine.
2) Table:
Tables are used to present data systematically, making it easy for readers to understand results. In this study, tables summarized precision, accuracy, and linearity, providing clear visual evidence of the UPLC method's performance, which is essential for validation in analytical chemistry.
3) India:
India is the geographic location where the research was conducted, reflecting the country's growing contributions to pharmaceutical development and analytical method validation. The study highlighted institutions in India engaging in advanced research, supporting the global pharmaceutical landscape.
4) Drug:
A drug, in this context, refers to olanzapine, an atypical antipsychotic used for treating schizophrenia and bipolar disorder. Understanding the drug's quantification is crucial for pharmaceutical efficacy and safety, and developing methods to analyze it solidifies its clinical relevance.
5) Performance:
Performance in this study relates to the analytical method's efficiency, speed, and accuracy in measuring olanzapine concentrations. The emphasis on high performance in UPLC techniques demonstrates the need for robust methodologies that improve drug testing and pharmacokinetics.
6) Measurement:
Measurement entails quantifying olanzapine concentrations through UPLC techniques. Accurate measurement is critical in pharmaceutical analysis to ensure drug quality, efficacy, and safety, and the study's focus on precise measurement techniques aligns with best practices in the industry.
7) Relative:
Relative refers to the comparison of results, such as peak areas and standard deviations in this study. Using relative terms helps contextualize measurement data, allowing for assessment of the UPLC method's consistency and reliability through statistical analysis.
8) Quality:
Quality reflects the standards upheld in pharmaceutical products. In this study, quality assurance is emphasized through the development of a validated UPLC method, ensuring that olanzapine formulations meet set safety and efficacy thresholds as mandated by regulatory bodies.
9) Blood:
Blood is mentioned in the context of determining olanzapine levels in biological matrices. The methods described indicate the potential for application beyond pharmaceutical products alone, highlighting the importance of bioanalysis for monitoring drug therapeutics in clinical settings.
10) Study (Studying):
Study refers to the systematic investigation carried out to develop and validate a UPLC method for olanzapine. This research contributes to scientific knowledge and practical applications in analytical chemistry and pharmaceutical manufacturing, addressing a gap noted in previous literature.
11) Purification:
Purification is a necessary process in preparing samples for analysis. The study mentions the use of purified water for buffer preparation, ensuring the chromatographic results are reliable and devoid of contaminants that could hinder accurate readings.
12) Discussion:
Discussion sections in research papers analyze results, contextualize findings, and interpret data. In the study, this section allows the authors to reflect on the efficacy of the developed method against existing methodologies, further clarifying the advantages and implications of their work.
13) Developing:
Developing refers to the process of creating the UPLC method for olanzapine analysis. This aspect of research is fundamental as it highlights innovation in analytical techniques, aiming for improved speed, efficiency, and accuracy in pharmaceutical testing.
14) Knowledge:
Knowledge in this context pertains to the scientific understanding gained through the study. The research expands the existing body of knowledge on olanzapine analysis, contributing to continuous improvement in analytical methods and methodologies within the pharmaceutical industry.
15) Rathore:
R.P.S. Rathore is one of the authors contributing to the research. Including authorship highlights collaboration and collective expertise in conducting the study, underscoring the integrated effort among researchers for advancing pharmaceutical analyses in the industry.
16) Udaipur (Udaypur):
Udaipur is a city in India where part of the research team is based. Its mention reflects the geographical diversity of research institutions involved in pharmaceutical sciences, indicating the local contributions to the global scientific community.
17) Science (Scientific):
Science is the systematic enterprise that builds and organizes knowledge. This study exemplifies the scientific method in action: identifying a problem, formulating hypotheses, conducting experiments, and validating results in the field of analytical chemistry for pharmaceuticals.
18) Rajput:
Chatrasal Singh Rajput is one of the researchers involved in the study. Mentioning individual contributors emphasizes the collaborative nature of research and the diversity of expertise necessary to achieve validated and reliable analytical methods.
19) Purity:
Purity refers to the quality of the olanzapine standard used in this research (98.9%). It is crucial in analytical chemistry as the accuracy of quantitative results depends on the substance's purity, impacting the reliability of the overall UPLC method.
20) Powder:
Powder refers to the form of olanzapine tablets used in the study. The preparation process for the powder is integral for analysis, as proper dissolution and sample handling techniques directly influence the UPLC results and their subsequent interpretation.
21) Navya:
Navya Khandelwal is one of the authors of the research study. Mentioning the authors illustrates the collaborative and interdisciplinary nature of scientific research, showcasing the various professionals engaged in developing and validating analytical methods.
22) Life:
In this context, 'Life' refers to Jubilant Life Sciences India, the entity from which the olanzapine standard was procured. This association emphasizes the industrial collaboration between research and pharmaceutical companies, underpinning advancements in drug analysis and development.
Other Science Concepts:
Discover the significance of concepts within the article: ‘Analytical method development and validation of olanzapine in formulated product’. Further sources in the context of Science might help you critically compare this page with similair documents:
Quality Control, High performance liquid chromatography, Calibration curve, System Suitability, Percentage recovery, Analytical method development, Method validation, Ultra violet detection, Pharmaceutical dosage form, Robustness, Linearity, Recovery data, Accuracy Recovery, Quantitative determination, Chromatographic condition, Sample solution preparation, Detection limit, Precision of the method, Analytical technique, Assay Method, Validation of analytical method, Reverse Phase Ultra Performance Liquid Chromatographic (RP-UPLC), Elution time, Water Acquity BEH C18 column, Linearity assessment, Atypical antipsychotic, Sample weight, Stability of solution, Reverse phase ultra performance liquid chromatographic, Olanzapine sample, Dilution done, Validated reverse phase analytical method, Standard Area, Cumulative RSD, Gradient RP-UPLC Method, Rapid Analysis.