RP-HPLC method for gemcitabine HCL analysis in bulk and dosage forms.
Journal name: World Journal of Pharmaceutical Research
Original article title: Analytical method development and validation for gemicitabine hcl in bulk and pharmaceutical dosage form by rp-hplc method
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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B. Siddartha, Dr. I. Sudheer Babu, Ch. Ravichandra Gupta, C. Parthiban
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: Analytical method development and validation for gemicitabine hcl in bulk and pharmaceutical dosage form by rp-hplc method
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
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Summary of article contents:
Introduction
Gemcitabine hydrochloride is a nucleoside metabolic inhibitor recognized for its antitumor activity, predominantly used in treating various cancers including pancreate, lung, breast, and kidney malignancies. This article discusses the development and validation of a rapid and sensitive reverse phase high performance liquid chromatography (RP-HPLC) method specifically designed for estimating gemcitabine hydrochloride in bulk and pharmaceutical formulations. The study emphasizes the method's adherence to International Conference on Harmonisation (ICH) guidelines to ensure reliability and accuracy for routine quality control analysis in pharmaceutical settings.
Method Development and Validation
The RP-HPLC method utilized a Hypersil BDS C18 column and a mobile phase composed of 93% buffer and 7% acetonitrile. The elution was isocratic, and the flow rate was maintained at 1.0 ml/min, with a detection wavelength of 275 nm and a retention time of approximately 3.927 minutes for gemcitabine hydrochloride. Calibration curves demonstrated excellent linearity in the 10-60 µg/ml range with a correlation coefficient of 0.9997. During validation, parameters such as system suitability, specificity, precision, accuracy, robustness, and ruggedness were meticulously evaluated, confirming the developed method's effectiveness.
Precision and Accuracy Results
The precision of the developed method was assessed through repeatability and intermediate precision tests, showcasing relative standard deviation (RSD) values consistently below 1%. Accuracy was examined across 50%, 100%, and 150% spiked levels of gemcitabine hydrochloride, yielding recovery rates between 99.20% and 101.24%. These findings suggest that the method can generate reliable results across various concentrations, further establishing its viability for regular application in pharmaceutical quality control.
Limit of Detection and Quantification
For robust analytical methods, the limits of detection (LOD) and quantification (LOQ) are crucial. In this work, the LOD was determined to be 0.296 µg/ml, while the LOQ was set at 0.896 µg/ml. These values indicate the sensitivity of the method, allowing for the detection of trace amounts of gemcitabine hydrochloride in pharmaceutical formulations. The successful determination of LOD and LOQ aligns with ICH guidelines, highlighting the method's potential for practical applications in quality assessment.
Conclusion
The RP-HPLC method developed for gemcitabine hydrochloride is characterized by its rapidity, accuracy, and sensitivity, utilizing minimal solvents and straightforward operational parameters. It reliably differentiates the drug from common excipients and impurities, making it suitable for routine quality control in pharmaceutical laboratories. The study confirms the method's effectiveness as a routine analytical tool, offering a dependable strategy to maintain the quality of gemcitabine hydrochloride in bulk and dosage forms. The authors acknowledge the support provided by Malla Reddy College of Pharmacy and Dr. Reddy Laboratory in realizing this research.
FAQ section (important questions/answers):
What is the purpose of the developed RP-HPLC method in this study?
The purpose of the developed RP-HPLC method is to provide a simple, sensitive, and rapid analytical technique for estimating gemicitabine hydrochloride in pure and pharmaceutical dosage forms.
What are the main components of the mobile phase used in the method?
The mobile phase consists of a mixture of buffer and acetonitrile in a ratio of 93:7 v/v, which ensures good resolution and sensitivity for gemicitabine hydrochloride.
What were the limit of detection (LOD) and quantification (LOQ) for gemicitabine?
The limit of detection (LOD) for gemicitabine hydrochloride was found to be 0.296 µg/ml, and the limit of quantification (LOQ) was 0.896 µg/ml, indicating the method's sensitivity.
How was the method validated according to industry standards?
The method was validated according to ICH guidelines, assessing parameters such as specificity, linearity, precision, accuracy, robustness, and ruggedness, ensuring reliability for routine analysis.
What was the correlation coefficient for the calibration curve?
The calibration curve for gemicitabine hydrochloride exhibited a correlation coefficient of 0.9997, demonstrating excellent linearity within the tested concentration range of 10 to 60 µg/ml.
What were the recovery percentages from accuracy tests in the study?
The accuracy tests show recovery percentages ranged from 99.20% to 101.24%, indicating that the method provides reliable and accurate results for gemicitabine hydrochloride.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “RP-HPLC method for gemcitabine HCL analysis in bulk and dosage forms.”. 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 scientific literature, a table serves to organize and present data clearly for easy reference. In the document, tables summarize critical findings concerning the validation of the RP-HPLC method, including results for accuracy, linearity, precision, and assays. Tables enhance the readability and comprehension of the research outcome.
2) Drug:
The term drug refers to a chemical substance used for medical purposes, particularly for diagnosis, treatment, or prevention of diseases. In this article, gemcitabine hydrochloride is emphasized as a potent chemotherapeutic agent, illustrating its importance in cancer therapies. The analysis aims to ensure the drug's efficacy and safety.
3) Water:
Water, specifically high-performance liquid chromatography (HPLC) grade water, is crucial as a solvent in many pharmaceutical analyses. It acts as a mobile phase component for elution in the chromatographic technique described. The purity of water impacts the accuracy of the assay and the quality of results in analytical methods.
4) Malla (Mallā, Mālla):
Malla Reddy College of Pharmacy, associated with the research, represents an academic institution that contributes to the study's credibility. It provides an environment for research and training in pharmaceutical analysis, highlighting its role in advancing educational and practical knowledge in the field of pharmacy and drug analysis.
5) Quality:
Quality refers to the standard of something as measured against other things of a similar kind. In this context, the quality of gemcitabine hydrochloride is critical for ensuring that the drug is effective and safe for patients. The development of the RP-HPLC method illustrates a structured approach to quality control.
6) Science (Scientific):
Science is the systematic enterprise that builds and organizes knowledge in the form of testable explanations and predictions about the universe. This research exemplifies scientific methods, such as method development and validation, to ensure reliable results in pharmaceutical analysis, showcasing how science underpins medical advancements.
7) Purity:
Purity of a pharmaceutical compound indicates the absence of impurities and is vital for determining drug efficacy and safety. In the study, assays for gemcitabine hydrochloride are performed, ensuring that the drug meets purity specifications necessary for therapeutic use, thus safeguarding patient health.
8) Powder:
Powder refers to the physical state of a drug, particularly in pharmaceutical preparations. In the context of the document, gemcitabine is available in powdered form for injection. Analyzing the powdered dosage form is critical for accurate dosing and efficacy in clinical applications of the drug.
9) India:
India is the geographical and cultural context of the research, indicating the region where the study and corresponding pharmaceutical analysis are conducted. The presence of various pharmaceutical companies and research institutions in India underlines the country’s growing influence in the global pharmaceutical landscape and research.
10) Study (Studying):
Study represents a comprehensive examination of a subject. In this context, the study focuses on developing and validating an analytical method for gemcitabine hydrochloride. The structured investigation provides insights into the drug’s analytical profile, ensuring that the findings contribute valuable knowledge to pharmaceutical sciences.
11) Performance:
Performance in this context refers to how well the proposed RP-HPLC method functions in quantifying gemicitabine hydrochloride. The method’s performance is critical to its application in routine analysis and quality control, ensuring reliability and accuracy in determining drug concentrations in pharmaceutical dosage forms.
12) Discussion:
Discussion is a crucial section in scientific literature where the results are interpreted and implications are considered. In this document, the discussion section details the significance of the findings, validates the proposed method, and contextualizes the study within the broader landscape of pharmaceutical research.
13) Activity:
Activity in the context of this research relates to the pharmacological effects of gemcitabine hydrochloride as an antitumor agent. Understanding the activity of a drug is essential for determining its therapeutic applications, especially in treating various types of cancer, thereby stemming from its underlying biochemical mechanisms.
14) Relative:
Relative refers to considerations of comparison within this research. Specifically, it pertains to how the results and methods compare to existing techniques and standards of drug analysis. Relative performance ensures that new methods provide equivalent or improved results compared to established practices in pharmaceutical analysis.
15) Mandal:
Mandal refers to a subdivision within administrative regions in India. In this context, it highlights the geographical location of the research, placing it within the broader framework of local governance. This element of localization underscores the regional involvement in pharmaceutical research and development in India.
16) Cancer:
Cancer is a significant health concern, and the research focuses on gemcitabine hydrochloride, an important drug used in cancer treatment. Understanding drugs like gemcitabine is critical for developing effective therapies against different cancers. The study's relevance highlights the ongoing fight against cancer and the need for effective treatment regimens.
17) Gupta (Guptā):
Gupta refers to Ch. Ravichandra Gupta, one of the co-authors of the study. His contributions are pivotal in providing expertise within the research framework. The inclusion of his name signifies collaboration and multidisciplinary approaches crucial for advancing scientific knowledge in pharmaceutical research.
18) Medak (Meḍak):
Medak is a district in India, which provides geographical context for the affiliated authors and their contributions to the research. Understanding the regional backdrop enhances the narrative of pharmaceutical development and analysis, showcasing local academic and industrial collaborations in advancing research capabilities.
19) Death:
Death is a biological conclusion often related to disease progression, particularly in cancer contexts. The importance of drugs like gemcitabine is underscored by their role in extending life and improving the quality of life for cancer patients, making the study relevant in addressing mortality associated with cancers.
20) Babu (Bābū):
Babu refers to Dr. I. Sudheer Babu, a contributing author in the research. His role is pivotal in guiding the scientific inquiry, and his expertise enhances the reliability and quality of the study. Individual contributions from qualified researchers underscore the collaborative nature of the research undertaken.
21) Life:
Life signifies the biological aspect of living beings, particularly the focus on enhancing quality of life through medical interventions. In the context of this research, the effective treatment of cancer with drugs like gemcitabine hydrochloride aims to prolong life and mitigate the suffering of patients, highlighting its clinical importance.
Other Science Concepts:
Discover the significance of concepts within the article: ‘RP-HPLC method for gemcitabine HCL analysis in bulk and dosage forms.’. Further sources in the context of Science might help you critically compare this page with similair documents:
Statistical analysis, Pharmaceutical analysis, Limit of detection, Limit of quantification, Calibration curve, Intraday precision, Interday precision.