RP-HPLC method for simultaneous estimation of ampicillin and cloxacillin.
Journal name: World Journal of Pharmaceutical Research
Original article title: Analytical method development and validation for simultaneous estimation of ampicillin and cloxacillin capsules by using rp-hplc
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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Vegesna Swetha, S. V. U. M. Prasad and S. Neha
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: Analytical method development and validation for simultaneous estimation of ampicillin and cloxacillin capsules by using rp-hplc
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
Doi: 10.20959/wjpr201714-10041
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Summary of article contents:
Introduction
The analysis of pharmaceutical compounds in combined dosage forms poses various analytical challenges, particularly for antibiotics like ampicillin and cloxacillin. This research article reports the development and validation of a reverse phase high-performance liquid chromatography (RP-HPLC) method aimed at simultaneously estimating ampicillin and cloxacillin from capsule formulations. The primary goal of this method is to provide a simple, accurate, and rapid way to evaluate these drugs, thereby enhancing the efficiency of quality control processes in pharmaceutical labs.
Development of the Analytical Method
The RP-HPLC method established in this study utilizes a P.Hypersob C18 column under specific chromatographic conditions. The mobile phase consists of a mixture of acetonitrile and a phosphate buffer at pH 3.0, enabling effective separation of the analytes at a flow rate of 1.8 mL/min, with UV detection at a wavelength of 225 nm. The method ensures a rapid run time of 10 minutes, with consistent retention times noted for both ampicillin (1.3 minutes) and cloxacillin (6.0 minutes). Linearity was demonstrated across a specified concentration range, confirming the reliability of the method for quantitative analysis.
Method Validation and Parameters
Method validation was carried out in accordance with ICH guidelines, focusing on accuracy, precision, specificity, and robustness. System suitability tests indicated that the method's tailing factor and theoretical plate count fell within acceptable limits. Precision assessments evaluated both intra-day and inter-day variabilities, showcasing low relative standard deviations (RSD), which indicates reproducibility. The method also elegantly determined the limits of detection and quantitation for both drugs, underscoring its sensitivity and efficiency in practical scenarios.
Degradation Studies
Degradation studies were conducted under various stress conditions, such as acid and base hydrolysis, oxidative exposure, thermal stress, and photolytic conditions to examine the stability of the analytes. Results indicated that the method could robustly measure ampicillin and cloxacillin even in the presence of degradation products, which signifies its reliability in determining active pharmaceutical ingredients in diverse environmental conditions. The study further confirms that the developed method can distinguish between stable and degraded compounds effectively.
Conclusion
In conclusion, the newly developed RP-HPLC method presents a valuable analytical tool for the simultaneous determination of ampicillin and cloxacillin in pharmaceutical formulations. The achieved levels of accuracy, precision, and robustness, combined with its rapid analysis time, make this method suitable for routine quality control in the pharmaceutical industry. This research not only contributes to improving drug analysis but also addresses the need for cost-effective and efficient methodologies in pharmaceutical validation processes.
FAQ section (important questions/answers):
What is the purpose of the developed RP-HPLC method?
The developed RP-HPLC method is used for the simultaneous estimation of Ampicillin and Cloxacillin in capsule dosage forms. It aims to provide a simple, accurate, and rapid analysis for quality control in pharmaceutical applications.
What are the key components of the mobile phase in this method?
The mobile phase consists of acetonitrile and a 0.002 M phosphate buffer at pH 3.0 in a ratio of 35:65. This composition is crucial for achieving effective separation during the chromatographic process.
What were the retention times for Ampicillin and Cloxacillin?
The retention time for Ampicillin was approximately 1.3 minutes, while Cloxacillin had a retention time of about 6.0 minutes. These times allow for the effective separation and quantification of both drugs in the sample.
How was method validation performed according to guidelines?
The method validation was conducted following ICH guidelines, assessing parameters such as accuracy, precision, specificity, linearity, limit of detection, and robustness to ensure reliability and effectiveness in analyzing the pharmaceuticals.
What results were obtained from the accuracy study of the method?
The accuracy study showed satisfactory recoveries of Ampicillin and Cloxacillin at various concentration levels, indicating that the developed method is accurate for quantifying both drugs in pharmaceutical formulations.
What degradation studies were performed on the method?
Degradation studies were conducted under stress conditions such as acid and base hydrolysis, oxidation, thermal, and photolytic stress. This demonstrated the stability of the method and its applicability for analyzing potentially degraded substances.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “RP-HPLC method for simultaneous estimation of ampicillin and cloxacillin.”. 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:
The term 'Table' refers to structured data presented in a grid format, allowing for easy comparison and analysis. In scientific literature, tables often summarize experimental results, parameters, and findings clearly and concisely, aiding readers in quickly understanding key data points crucial for interpreting the study's outcome and methodology.
2) Drug:
A 'Drug' is any substance that is used for medical treatment, diagnosis, or prevention of disease. In the context of this article, drugs like Ampicillin and Cloxacillin represent antibacterial agents critical in treating infections, highlighting their importance in pharmacology and healthcare. Understanding drug interactions and effects is vital for effective medical practice.
3) India:
India is significant as the location of the research conducted. It is home to a rapidly growing pharmaceutical industry, contributing to global drug supply and development. The investigation of Ampicillin and Cloxacillin in India underscores the region's role in pharmaceutical advancements and the importance of validating drug efficacy within diverse health care systems.
4) Substance:
A 'Substance' refers to any form of matter with defined composition and properties, including chemicals used in pharmaceutical formulations. In this study, both Ampicillin and Cloxacillin are considered substances analyzed for their stability and efficacy. The investigation emphasizes the need to assess the quality and safety of such substances in pharmaceutical applications.
5) Performance:
In a scientific context, 'Performance' refers to how effectively a method or drug accomplishes its intended purpose. Here, the performance of the RP-HPLC method is evaluated through various parameters, ensuring it accurately and reliably quantifies the drugs of interest. This assessment is crucial for ensuring the method meets rigorous standards in laboratory practices.
6) Antibiotic (Antibacterial):
An 'Antibiotic' is a type of drug specifically designed to combat bacterial infections. Ampicillin and Cloxacillin are examples of antibiotics that inhibit bacterial growth. Their study is essential in understanding how these drugs function, their effectiveness against specific bacteria, and their role in treating infections, which is critical for public health.
7) Relative:
The term 'Relative' pertains to the comparison of substances or methods in relation to one another. In this research, it often refers to the simultaneous estimation of Ampicillin and Cloxacillin in formulations, demonstrating the importance of understanding their interactions and effects together, ensuring accurate dosage and efficacy in treatments.
8) Water:
'Water' is a universal solvent and a critical component in many pharmaceutical processes, including drug formulation and analysis. In this research, water is employed in preparing solutions necessary for HPLC. Its purity and quality are essential for accurate results in assessing drug concentrations and ensuring valid experimental outcomes.
9) Study (Studying):
'Study' denotes the systematic investigation and analysis of a topic, typically to derive conclusions based on empirical evidence. In this context, the study refers to the research conducted on the analytical method for quantifying Ampicillin and Cloxacillin, highlighting the rigor involved in ensuring method validity and reliability in pharmaceutical analysis.
10) Discussion:
The 'Discussion' section of a research paper allows authors to interpret results and link them to existing literature. It is crucial for explaining the implications of findings, comparing them with previous studies, and outlining future research directions. This section enhances the understanding of the significance of the research conducted.
11) Observing:
'Observing' refers to the act of closely monitoring or examining phenomena, crucial in scientific research. In this study, observing chromatographic results is necessary to assess the method's efficacy and precision. Careful observation of parameters facilitates accurate conclusions about the performance and reliability of the analytical process used.
12) Quality:
'Quality' represents the degree to which a product meets specified requirements and standards. In pharmaceutical contexts, ensuring quality is essential for patient safety and therapeutic efficacy. This study emphasizes the importance of high-quality results from the analytical method developed, which is critical for the effective quantification of the drugs assessed.
13) Science (Scientific):
'Science' is a systematic enterprise that builds and organizes knowledge through testable explanations and predictions. In this article, the application of scientific principles provides the foundation for developing and validating the RP-HPLC method for drug estimation, illustrating the importance of scientific rigor in pharmaceutical research and development.
14) Powder:
'Powder' refers to a solid substance that has been finely ground, often used in drug formulation. In this research, capsules containing drug powders are analyzed for their content and efficacy. Understanding the properties of powders is vital for ensuring proper dosage and distribution in pharmaceutical applications.
15) Noise:
'Noise' in a scientific context refers to unwanted variations in data that can obscure the true signal being measured. In HPLC, minimizing noise is essential for achieving clear results. Addressing noise levels during drug analysis ensures the reliability and accuracy of the measurements obtained, thus impacting the integrity of the study.
16) Ras (Rash):
'Rash' signifies an allergic response often associated with antibiotic use, such as Ampicillin. Recognizing potential side effects like rashes is critical in pharmacology, as it informs healthcare providers about patients' safety and tolerability of prescribed medications. The study underlines the need to balance efficacy against adverse reactions in antibiotic administration.