Stable RP-HPLC method for labetalol HCl in formulations
Journal name: World Journal of Pharmaceutical Research
Original article title: Stability indicating rp – hplc method for determination of labetalol hcl in pharmaceutical formulation
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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Vaishali C. Kulkarni, Bhavika R. Chavhan, S. R. Bavaskar, S. D. Barhate
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: Stability indicating rp – hplc method for determination of labetalol hcl in pharmaceutical formulation
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
Copyright (license): WJPR: All rights reserved
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Summary of article contents:
Introduction
Labetalol hydrochloride is an adrenergic β-receptor blocking agent extensively used for treating hypertension. It exhibits both α- and β-adrenoceptor blocking activities, making it effective in rapidly reducing blood pressure during surgeries. However, due to its potential hepatotoxicity and renal failure upon overdose, there is a pressing need for reliable and straightforward analytical methods to assess its concentration in pharmaceutical preparations. This study presents a simple, rapid, and accurate stability-indicating reversed-phase high-performance liquid chromatography (RP-HPLC) method developed specifically for quantifying Labetalol HCL in both pure and tablet forms.
Stability-Indicating Capability
One of the critical aspects of the developed RP-HPLC method is its stability-indicating capability. The method effectively separates Labetalol from its degradation products following various stress conditions, including acid, base, oxidative, and thermal degradation. During the forced degradation studies, it was established that the active pharmaceutical ingredient (API) could be separated from degradation products, confirming the method’s reliability for stability testing. The chromatograms displayed distinct peaks for Labetalol and its degradation products, demonstrating the method's specificity and robustness under stressed conditions.
Method Validation and Performance
The validation of the RP-HPLC method was conducted based on parameters such as linearity, accuracy, precision, limit of detection (LOD), and limit of quantification (LOQ). The method exhibited a linear response for Labetalol HCL concentrations ranging from 10 to 50 µg/ml, with a correlation coefficient (R²) of 0.999. The LOD was determined to be 0.24 µg/ml, and the LOQ was 0.72 µg/ml, emphasizing the method's high sensitivity. Furthermore, repeatability data demonstrated minimal variation across different analysts and trials, indicating that the method is reliable for quality control purposes in pharmaceutical applications.
Chromatographic Conditions
The optimized chromatographic conditions significantly contributed to the success of the RP-HPLC method. Utilizing a mobile phase composed of methanol and water in a 70:30 ratio, with a constant flow rate of 1 ml/min and UV detection at 246 nm, enables efficient analysis. The column was equilibrated for 30 minutes to ensure accurate readings, and the retention time for Labetalol HCL was consistently found to be around 6.3 minutes. These conditions not only facilitated the separation of Labetalol but also ensured that the peaks were well-resolved and symmetrical, reflecting the method's effectiveness.
Conclusion
The study successfully established a rapid, accurate, and precise stability-indicating RP-HPLC method for the determination of Labetalol HCL in pharmaceutical formulations. The method has demonstrated its capability to separate the analyte from degradation products and is suitable for use in routine quality control laboratories. The findings affirm that the proposed analytical procedure is not only reliable and robust but also efficient for determining Labetalol HCL concentrations in various pharmaceutical and biological contexts, paving the way for better management of this critical medication.
FAQ section (important questions/answers):
What is the purpose of the developed RP-HPLC method?
The developed RP-HPLC method aims to determine Labetalol HCL accurately in pharmaceutical formulations and assess its stability under various degradation conditions.
What was the mobile phase used in the method?
The mobile phase used was a Methanol: Water solution in a 70:30 ratio, adjusted with 0.05% OPA, and pumped at a flow rate of 1 ml/min.
How was the method validated for accuracy and precision?
The method was validated by assessing parameters like linearity, recovery, precision, specificity, and ruggedness, with RSD values below 2% indicating high accuracy and precision.
What degradation conditions were studied for Labetalol HCL?
Degradation studies examined Labetalol HCL under acidic, basic, oxidative, thermal, and neutral conditions to evaluate the method's ability to separate the drug from degradation products.
What were the limits of detection and quantitation for the method?
The limit of detection (LOD) was 0.24 µg/ml, while the limit of quantitation (LOQ) was found to be 0.72 µg/ml, indicating the method's sensitivity.
What is the significance of the findings in this study?
The findings demonstrate that the developed RP-HPLC method is simple, rapid, and effective for routine analysis of Labetalol HCL in pharmaceutical markets, ensuring quality control.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “Stable RP-HPLC method for labetalol HCl in formulations”. 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) Vaishali (Vaisali):
Vaishali refers to the first author of the study, Vaishali C. Kulkarni, who is associated with the Department of Quality Assurance at the Shree Sureshdada Jain Institute of Pharmaceutical Education and Research. The inclusion of her name indicates her contribution and authority in the field of pharmaceutical research and the specific study of Labetalol HCL.
2) Table:
In this context, a 'Table' refers to structured data presentation, commonly used to summarize and compare experimental results within the research. Tables are essential for conveying quantitative findings, including results of stress studies, validation results, and precision metrics, crucial for understanding the method’s effectiveness and reliability.
3) Water:
Water, as mentioned in the article, is a component of the mobile phase for the RP-HPLC method, specifically in a 70:30 ratio with methanol. It is significant because the choice of water and methanol affects the interactions within the chromatography process, thereby influencing the separation and detection of Labetalol HCL.
4) Drug:
The term 'Drug' specifically pertains to Labetalol HCL, a medication used primarily for treating hypertension. It plays a central role in this study as the primary substance being analyzed. Understanding its properties, stability, and degradation is crucial for ensuring effective pharmaceutical formulation and patient safety.
5) Quality:
Quality refers to the standards of purity, potency, and overall effectiveness of pharmaceutical products. In this study, the quality assurance practices are emphasized to validate the analytical method for determining Labetalol HCL, ensuring that the medication meets the necessary regulatory and safety requirements before reaching consumers.
6) Powder:
Powder indicates the physical state of Labetalol HCL in its active pharmaceutical ingredient (API) form. The analysis of the drug in powdered form is essential for understanding its stability and degradation behaviors, serving as a basis for formulating effective dosage forms, such as tablets or capsules.
7) Education:
Education references the academic context of the research, specifically the Shree Sureshdada Jain Institute of Pharmaceutical Education and Research. This suggests that the study not only contributes to scientific knowledge but also serves as an educational resource for students and professionals in the field of pharmaceutical sciences.
8) Medium:
In this research, 'medium' refers to the mobile phase employed in the RP-HPLC method. The selection of the correct medium is pivotal for effective chromatographic separation. The medium's composition significantly impacts the retention time and peak shapes of the analyte during the analysis of Labetalol HCL.
9) Shri (Sri, Sr):
Shree denotes the institute's name, Shree Sureshdada Jain Institute of Pharmaceutical Education and Research, where the research was conducted. This emphasizes the institutional background of the study, providing context about the research environment and its commitment to pharmaceutical education and innovation.
10) Pharmacological:
Pharmacological relates to the study of how drugs affect biological systems. In the presented research, the pharmacological properties of Labetalol HCL are essential as they determine the drug's therapeutic effects, including its dual action as an α- and β-receptor blocker in managing hypertension.
11) Performance:
Performance in this study pertains to the efficiency and effectiveness of the developed RP-HPLC method in analyzing Labetalol HCL. Evaluating performance includes assessing parameters like linearity, precision, accuracy, and robustness to ensure reliable quality control in pharmaceutical applications.
12) Discussion:
Discussion refers to the section of the research article where the authors interpret results, compare with existing literature, and address the significance of findings. This is critical for providing insights into the implications of Labetalol HCL analysis and its relevance in pharmaceutical formulations.
13) Substance:
Substance in this context refers to the specific chemical composition and identity of Labetalol HCL as a drug. Understanding the substance's characteristics, including stability and degradation, is crucial for its formulation, safety, and effectiveness in treating conditions such as hypertension.
14) Activity:
Activity relates to the pharmacological effects and mechanisms of action of Labetalol HCL as a drug. Highlighting its activity is important for understanding how it functions in the body and its therapeutic potential, as well as its implications for safe usage.
15) Relative:
Relative pertains to the comparisons made between Labetalol HCL and its degradation products or other substances during the study. Evaluating relative stability and separation capabilities of the analytical method is crucial for confirming its effectiveness in routine quality control.
16) Nature:
Nature refers to the inherent characteristics and stability of Labetalol HCL throughout various degradation studies. Understanding the nature of the drug under different conditions is critical for ensuring its reliability and safety in pharmaceutical formulations.
17) Blood:
Blood in this context may relate to the pharmacokinetics of Labetalol HCL and its role in managing blood pressure in hypertensive patients. Understanding the drug's effects on blood pressure regulation is vital for therapeutic applications and its relevance in clinical practice.
18) Study (Studying):
Study refers to the systematic investigation conducted to evaluate the stability-indicating method for Labetalol HCL using RP-HPLC. The outcomes of the study contribute to the body of knowledge in pharmaceutical analysis and ensure that the drug can be effectively monitored for quality assessment.
Other Science Concepts:
Discover the significance of concepts within the article: ‘Stable RP-HPLC method for labetalol HCl in formulations’. 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, Limit of detection, Liquid chromatography-tandem mass spectrometry, Calibration curve, Intraday precision, Interday precision, Analytical Procedure, Pharmaceutical formulation, Indian Pharmacopoeia, RP-HPLC Method, Limit of quantitation, Linear regression analysis, Specificity of the method, Chromatographic condition, Standard solution, Analytical technique, Clinical chemistry.