Simultaneous RP-HPLC estimation of azithromycin and cefixime.

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Journal name: World Journal of Pharmaceutical Research
Original article title: Simultaneous estimation of azithromycin and cefixime in bulk and pharmaceutical formulation by reverse phase high performance liquid chromatography (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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Author:

Usharani Gundala, Chandrashekar Bonagiri , Devanna Nayakanti


World Journal of Pharmaceutical Research:

(An ISO 9001:2015 Certified International Journal)

Full text available for: Simultaneous estimation of azithromycin and cefixime in bulk and pharmaceutical formulation by reverse phase high performance liquid chromatography (rp-hplc)

Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research


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Summary of article contents:

Introduction

The research article discusses the development and validation of a reverse phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of two antibiotics, Azithromycin and Cefixime, in bulk and pharmaceutical formulations. The necessity for such a method arises from the absence of existing UV or HPLC techniques that can analyze these two drugs concurrently. The authors aim to provide a simple, specific, accurate, and cost-effective means of analyzing these antibiotics, particularly in the combined tablet dosage form Zifi-AZ.

Method Development and Chromatographic Conditions

The chromatographic analysis was performed using a Kromasil C18 column with a mobile phase consisting of Ortho Phosphoric Acid buffer and Methanol in a 70:30 v/v ratio. The flow rate was maintained at 1 ml/min, and detection was executed at a wavelength of 292 nm. The retention times for Azithromycin and Cefixime were identified as 2.8 minutes and 3.9 minutes, respectively. The method was validated against various analytical parameters as outlined in the International Conference on Harmonization (ICH) guidelines. The linearity of detector response was confirmed to be in the ranges of 0.5–1.5 mg/ml for Azithromycin and 0.4–1.2 mg/ml for Cefixime.

Validation Parameters and Results

The validation parameters included precision, accuracy, limit of detection (LOD), limit of quantification (LOQ), and robustness. Precision was assessed through intra-day and inter-day variations, with results reflecting that both antibiotics maintained a %RSD well within acceptable limits. The accuracy of the method was ascertained through recovery studies using the standard addition method, yielding high percentage recovery values. LOD and LOQ were calculated for each drug, with Azithromycin showing values of 0.89 mg/ml and 2.99 mg/ml, respectively, while Cefixime exhibited values of 0.71 mg/ml and 2.39 mg/ml.

Application and Practical Implications

The developed RP-HPLC method was effectively applied to analyze commercial formulations of Azithromycin and Cefixime. The precision of the results indicated the methodology's suitability for routine analysis in quality control laboratories. This method holds practical relevance not only for the assessment of raw materials and formulations but also for conducting dissolution studies and bioequivalence evaluations of the combined drug formulation.

Conclusion

In conclusion, the study successfully presents a novel HPLC method for the simultaneous estimation of Azithromycin and Cefixime, confirming its accuracy, precision, simplicity, and economic viability. The RP-HPLC method can serve as a reliable analytical tool for quality control in pharmaceutical settings. Given its favorable parameters, the methodology is poised for routine application in laboratories and may also facilitate further research related to bioequivalence in drug formulations involving these antibiotics.

FAQ section (important questions/answers):

What is the purpose of the developed RP-HPLC method?

The developed RP-HPLC method aims to simultaneously estimate Azithromycin and Cefixime in bulk and pharmaceutical formulations, ensuring accuracy and precision in analysis.

What were the main components of the mobile phase used?

The mobile phase consisted of Ortho Phosphoric Acid buffer and Methanol in a 70:30 v/v ratio to facilitate the chromatographic separation of the drugs.

How were the accuracy and precision of the method validated?

The method was validated through recovery studies and precision tests, which demonstrated low relative standard deviations, confirming its accuracy within acceptable limits.

What are the retention times for Azithromycin and Cefixime?

Azithromycin had a retention time of 2.8 minutes, while Cefixime was at 3.9 minutes, allowing for effective separation of both drugs during analysis.

What types of infections are treated with Azithromycin and Cefixime?

Both antibiotics treat various infections, including respiratory tract infections, urinary tract infections, skin infections, and other bacterial infections effectively.

What is the significance of this study for pharmaceutical analysis?

This study introduces a novel, cost-effective method for routine analysis of Azithromycin and Cefixime, enhancing quality control in pharmaceutical laboratories.

Glossary definitions and references:

Scientific and Ayurvedic Glossary list for “Simultaneous RP-HPLC estimation of azithromycin and cefixime.”. 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 the context of the research, 'Table' refers to structured data that presents quantitative results, such as precision and recovery studies for the analytical method developed. Tables are essential for communicating experimental findings in a clear and understandable format, allowing for easy comparison and interpretation of results within scientific literature.

2) Drug:
The term 'Drug' is critical in pharmacology, referring to substances used for medical treatment. In this study, 'Drug' specifically pertains to Azithromycin and Cefixime, which are antibiotics investigated for their simultaneous quantification through RP-HPLC. Understanding drug chemistry is vital for developing effective pharmaceutical formulations and treatments.

3) India:
India is relevant in this research as the geographical context for the study. The authors conducted their research at institutions located in India. The pharmaceutical industry in India plays a crucial role in global drug development, and studies like this contribute to the country's capability in producing effective medications.

4) Antibiotic (Antibacterial):
Antibiotics are substances that inhibit bacterial growth or kill bacteria, of which Azithromycin and Cefixime are examples. The study examines these antibiotics due to their significance in treating various infections. Understanding the role and efficacy of antibiotics is essential for addressing public health issues like bacterial resistance.

5) Study (Studying):
The term 'Study' denotes the investigation undertaken by the researchers to develop a new RP-HPLC method for estimating Azithromycin and Cefixime. Scientific studies are foundational in advancing knowledge and methodologies in pharmaceutical analysis, impacting drug formulation and quality control practices in healthcare settings.

6) Gundala (Guṇḍāḷā, Guṇḍālā, Gundāla, Gumdala):
Gundala is the surname of one of the authors, Usharani Gundala, indicating her contribution to the research. Including author names in scientific publications acknowledges individual efforts and expertise. The recognition of authorship is essential in academia, as it pertains to accountability and intellectual property.

7) Fever:
In this context, 'Fever' refers to a symptom often treated with antibiotics like Azithromycin and Cefixime. This highlights the medical relevance of the studied drugs, as they are prescribed for infections that may lead to fever. Understanding the indications for these antibiotics is critical for effective treatment in clinical practice.

8) Wall:
The term 'Wall' refers to bacterial cell walls, which are targeted by certain antibiotics, including Cefixime. Understanding the structure and function of bacterial walls is crucial in pharmacology since disrupting these walls effectively inhibits bacterial growth, making this knowledge central to antibiotic development and application.

9) Purification:
Purification refers to the process of removing impurities from substances, significant in drug preparation. In this study, purification relates to ensuring that the standards used for Azithromycin and Cefixime are of pharmaceutical grade, which is essential for accurate assay results and consistency in drug quality and safety.

10) Performance:
In the research context, 'Performance' pertains to the efficacy of the developed RP-HPLC method in accurately quantifying drugs. The performance of an analytical method is assessed through parameters such as precision and accuracy, which are essential for ensuring reliable results in pharmaceutical analysis and quality control.

11) Discussion:
The 'Discussion' section of a research paper interprets the findings and relates them to existing literature and hypotheses. This part critically evaluates the results, offering insights into the significance and implications of the study, as well as potential future research directions and application of the method in pharmaceutical industries.

12) Training:
Training in this context refers to the assistance provided by the Rainbow Pharma training lab, which facilitated analytical support. Such training is vital for researchers in developing technical skills necessary for conducting sophisticated methodologies in pharmaceutical analyses, enabling enhanced research capabilities and better quality assessments.

13) Relative:
'Relative' often pertains to comparative analysis within research, indicating how results of drug estimations may relate to each other. In this study, relative differences in precision, accuracy, and recovery metrics between the two antibiotics help establish method reliability and ensure comprehensive understanding of assay performance.

14) Quality:
Referring to the standard of the pharmaceutical products, 'Quality' is crucial in the field of pharmaceuticals. The study emphasizes the importance of quality in drug formulations, as ensuring acceptable quality levels directly impacts therapeutic effectiveness, safety, and regulatory compliance in pharmaceutical manufacturing and distribution.

15) Water:
In this research, 'Water' refers to the use of double-distilled water in preparing solutions for HPLC. The purity of water is critical in chromatography as it can influence the reliability of results. Using high-quality water helps minimize baseline noise and contaminants, ensuring accurate analytical readings.

16) Ulcer:
The term 'Ulcer' is associated with medical conditions that may necessitate antibiotic treatments. Cefixime is indicated for certain types of infections that can lead to ulcer complications. Understanding this context helps emphasize the clinical relevance of the antibiotics studied, linking them to patient treatment scenarios.

Other Science Concepts:

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Discover the significance of concepts within the article: ‘Simultaneous RP-HPLC estimation of azithromycin and cefixime.’. Further sources in the context of Science might help you critically compare this page with similair documents:

Chromatogram, Retention time, International Conference on Harmonization Guideline, Limit of detection, Limit of quantification, Recovery studies, Method validation, Pharmaceutical dosage form, Chromatographic condition, Analytical parameter.

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