HPTLC method for fexofenadine hydrochloride in bulk and tablets.
Journal name: World Journal of Pharmaceutical Research
Original article title: Development and validation of hptlc method for analysis of fexofenadine hydrochloride as a bulk drug and in tablet dosage form
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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Pallavi M. Sutar, Deepali A. Bansode and Suneela S. Dhaneshwar
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: Development and validation of hptlc method for analysis of fexofenadine hydrochloride as a bulk drug and in tablet dosage form
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
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Summary of article contents:
Introduction
Fexofenadine hydrochloride is a second-generation antihistamine primarily utilized for allergy symptom relief. The development and validation of a high-performance thin-layer chromatography (HPTLC) method for the quantitative analysis of fexofenadine hydrochloride in both its bulk form and in tablet dosage forms is the focus of this research. The method is designed to be simple, precise, accurate, and specific, thereby facilitating effective quality control in pharmaceutical applications.
HPTLC Method Development
The HPTLC method employs precoated silica gel aluminum plates as the stationary phase and a mobile phase comprising toluene, ethyl acetate, methanol, and ammonia (30%). Sample applications were made in bands of 6 mm width, and densitometric quantification occurred at a wavelength of 220 nm. The calibration curve established was linear between 1-10 μg/spot, confirming the method’s reliability for fexofenadine assessment. Method validation encompassed parameters such as linearity, precision, repeatability, and specificity following ICH guidelines.
Method Validation
Validation of the developed HPTLC method assessed its performance through metrics like precision, accuracy, limit of detection (LOD), and limit of quantitation (LOQ). The precision was evaluated both within the same day and over multiple days, indicating good reproducibility of results. Recovery studies were conducted to affirm the accuracy of the method, yielding percentages within acceptable limits. The LOD and LOQ were determined to be 0.05 μg/spot and 0.20 μg/spot, respectively, highlighting the sensitivity of the method.
Robustness and Specificity
Robustness testing was conducted by making minor alterations in analytical conditions, confirming that the method remained consistent with variations. Specificity was demonstrated through the separation of fexofenadine from impurities in tablet formulations, with peak purity confirmed by assessing densitograms at various positions. These tests ensure that the method is capable of accurately quantifying fexofenadine hydrochloride without interference from formulation excipients.
Conclusion
The validated HPTLC method for analyzing fexofenadine hydrochloride stands out as an effective, economical, and time-saving technique for routine analysis in pharmaceutical quality control laboratories. Its adherence to ICH guidelines and successful demonstration of precision and specificity make it a valuable tool for ensuring the quality of pharmaceutical formulations. The development of this method enhances the analytical capabilities available for assessing fexofenadine, furthering its application in clinical and pharmaceutical practices.
FAQ section (important questions/answers):
What was the objective of this research on fexofenadine hydrochloride?
The research aimed to develop and validate a high-performance thin-layer chromatographic (HPTLC) method for estimating fexofenadine hydrochloride in bulk and tablet dosage forms, ensuring simplicity, precision, accuracy, and specificity.
Which stationary and mobile phases were used in this HPTLC method?
The stationary phase utilized was precoated silica gel aluminum plates 60 F 254, and the mobile phase for separation consisted of toluene, ethyl acetate, methanol, and 30% ammonia in specific ratios.
How was the densitometric quantification performed for this study?
Densitometric quantification was carried out at a wavelength of 220 nm, with the scanning performed to determine peak areas corresponding to the concentration of fexofenadine hydrochloride.
What parameters were validated for the HPTLC method?
The method was validated concerning linearity, precision, repeatability, accuracy, limit of detection (LOD), limit of quantification (LOQ), robustness, and specificity according to ICH guidelines.
What were the limit of detection (LOD) and limit of quantitation (LOQ) values?
The LOD for fexofenadine hydrochloride was found to be 0.05 µg/spot, while the LOQ was determined to be 0.20 µg/spot, indicating the method’s sensitivity.
What is the significance of the developed HPTLC method?
The developed method offers a simple, precise, and cost-effective means for routine analysis of fexofenadine hydrochloride in pharmaceutical formulations, suitable for quality-control laboratories.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “HPTLC method for fexofenadine hydrochloride in bulk and tablets.”. 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:
Table refers to a systematic arrangement of data, usually in rows and columns, to present information clearly and efficiently. In scientific literature, it’s essential for summarizing results, such as calibration data, statistical analysis, and method validation specifics, facilitating quick reference and comprehension for researchers and readers.
2) Drug:
A drug is a substance used for medical purposes, such as diagnosis, treatment, or prevention of disease. In this context, fexofenadine hydrochloride is discussed as an antihistaminic drug used to alleviate allergy symptoms, showing the importance of pharmaceuticals in improving health and managing illnesses.
3) Maharashtra (Maharastra, Maha-rashtra):
Maharashtra is a state located in western India, significant for its contribution to India's pharmaceutical industry. As the geographical setting of the study, it showcases the local context where the research is conducted, emphasizing the region's role in drug development and quality control practices.
4) Poona:
Poona, now Pune, was historically significant in Maharashtra, renowned for educational institutions like the Poona College of Pharmacy. Its mention connects the research to a respected academic environment, highlighting the collaborative efforts in drug development and enhancing pharmacological education in India.
5) Pune:
Pune is a vibrant city in Maharashtra, India, and serves as a hub for pharmaceutical education and research. The inclusion of Pune indicates the location of the study's institution, underscoring its role in fostering knowledge, innovation, and advancements in the pharmaceutical sciences.
6) Relative:
Relative refers to a comparison between two or more entities. In scientific research, this word often describes how certain measurements, effects, or changes relate to others, indicating the importance of context in interpreting data and ensuring accurate conclusions in studies involving drug efficacy and safety.
7) Bharati:
Bharati, part of Bharati Vidyapeeth University, emphasizes the educational foundation of the research. It signifies the institution's commitment to pharmaceutical sciences, showcasing how academic institutions play a crucial role in advancing research and training professionals in drug development and quality assurance.
8) Purity:
Purity refers to the absence of contaminants in a substance. Ensuring the purity of fexofenadine hydrochloride is crucial in pharmaceuticals to confirm the drug's effectiveness and safety. It relates to quality control standards that govern pharmaceutical products, influencing patient health outcomes.
9) Nature:
Nature refers to the inherent characteristics of a substance or phenomenon. In the context of drug analysis, understanding the nature of fexofenadine hydrochloride pertains to its chemical, physical, and biological properties, which are essential for accurate measurement, formulation, and therapeutic effectiveness.
10) Nagapura (Naga-pura):
Nagpur is a city in Maharashtra, India, known for its industrial contributions and as the site of Zim Laboratories Ltd., which provided the fexofenadine sample. Mentioning Nagpur situates the study in a geographical context of pharmaceutical resources and collaborations vital for research efforts.
11) India:
India refers to the country where this research is conducted, significant for its rich tradition in medicinal practices and thriving pharmaceutical industry. This context is crucial as it showcases the global landscape of drug development and the specific challenges and advancements in Indian pharmaceuticals.
12) Glass:
Glass refers to the material used for laboratory equipment, such as glass chambers in chromatography. Its use in maintaining sterile and controlled environments is fundamental in scientific experiments, influencing the accuracy and reliability of analytical results in drug measurement.
13) Noise:
Noise refers to any irrelevant or extraneous signals that might interfere with measurements in analytical methods. In chromatography, controlling noise is crucial for enhancing the precision of results, ensuring that peaks indicate actual concentrations of the analyte being measured.
14) Performance:
Performance pertains to how well a method or system operates or accomplishes a task. In this study, it relates to the effectiveness of the HPTLC method for analyzing fexofenadine hydrochloride, emphasizing the method's optimization and reliability in pharmaceutical analyses.
15) Measurement:
Measurement involves quantifying a property or quality, essential in scientific analysis. In pharmaceutical contexts, accurate measurement of drug concentration is vital to ensure efficacy, safety, and consistency in formulations, directly impacting therapeutic outcomes and patient care.
16) Discussion:
The discussion section of a scientific paper interprets results and contextualizes findings within the broader field. It is crucial for understanding the implications of research, guiding further studies, and contributing to the overall knowledge of drug efficacy, methodologies, and quality assurance.
17) Drowsiness:
Drowsiness is a side effect associated with certain first-generation antihistamines. By contrasting fexofenadine with older antihistamines, the research highlights the benefits of using second and third-generation antihistamines, as they aim to minimize sedation while effectively managing allergy symptoms.
18) Knowledge:
Knowledge refers to the information, understanding, and skills gained through experience or education. In the context of pharmaceutical research, it underscores the importance of shared insights in developing methodologies, promoting innovation, and driving advancements in drug analysis and safety.
19) Quality:
Quality denotes the standard of something measured against other similar things. In pharmaceuticals, quality control ensures that drugs meet safety, efficacy, and purity standards, making it a fundamental aspect of drug development and a focus of the research described.
20) Allergy:
Allergy refers to a condition resulting from hypersensitivity to specific substances. The focus on fexofenadine hydrochloride, an antihistaminic drug, illustrates its significance in treating allergic reactions, emphasizing the vital role of pharmacological interventions in managing health conditions related to allergies.
21) Powder:
Powder refers to a solid state of a substance in finely ground form. Fexofenadine hydrochloride exists as a crystalline powder, which is crucial for formulation and administration in pharmaceuticals, influencing drug stability, solubility, and bioavailability.
22) Water:
Water is often a solvent used in pharmaceutical processes. Its presence in studies emphasizes the importance of understanding solubility and extraction methods in drug formulation. Correctly managing water interactions is vital for effective drug delivery and stability.
23) Fever:
Fever is a common symptom of many conditions, often related to infections or allergies. While fexofenadine hydrochloride primarily treats allergy symptoms, understanding fever's implications highlights broader pharmacological applications and the necessity of effective antihistaminic treatments.
24) Blood:
Blood denotes the vital fluid circulating in the body, transporting nutrients and medications. In pharmacology, understanding drug interactions with blood components is crucial for therapeutic efficacy and safety in treating conditions like allergies or inflammation.
25) Study (Studying):
Study refers to the systematic examination and analysis of a topic or phenomenon. In the context of pharmaceutical research, it embodies the principles of scientific inquiry aimed at developing, validating, and optimizing analytical methods, ensuring continual improvement in drug analysis methodologies.
26) Lamp:
Lamp refers to the light source used in experiments, particularly in UV-Vis spectroscopy. Its role in providing necessary illumination for scanning samples in chromatography is crucial for obtaining accurate measurement of drug concentrations.
27) Hair:
Hair can refer to the use of a hair dryer in drying chromatographic plates. This practice is significant to maintain quality control in the analytical process by ensuring proper conditions for accurate separation and quantification of samples.
Other Science Concepts:
Discover the significance of concepts within the article: ‘HPTLC method for fexofenadine hydrochloride in bulk and tablets.’. Further sources in the context of Science might help you critically compare this page with similair documents:
Pharmaceutical preparation, Accuracy, Analytical grade, High performance thin layer chromatography (HPTLC), Mobile phase, Densitogram, Quality control laboratories, Limit of detection, Limit of quantification, Method development, HPTLC method, Calibration curve, Limit of Detection (LOD), Limit of Quantification (LOQ), Analytical Procedure, Chemical formula, Pharmaceutical formulation, Specificity, RP-HPLC Method, Recovery studies, Method validation, British pharmacopoeia, Spectral analysis, Precision, Limit of quantitation, Tablet dosage form, Stationary phase, Chromatographic condition, Repeatability, ICH Guideline, Chromatographic method.