RP-HPLC method for simultaneous estimation of imipenem and cilastatin
Journal name: World Journal of Pharmaceutical Research
Original article title: Stability indicating rp-hplc method for the simultaneous estimation of imipenem and cilastatin in injection formulations
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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Murali D. and Purnachandra Rao G.
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: Stability indicating rp-hplc method for the simultaneous estimation of imipenem and cilastatin in injection formulations
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
Doi: 10.20959/wjpr20191-13867
Download the PDF file of the original publication
Summary of article contents:
Introduction
The study focuses on developing a stability-indicating Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) method for the simultaneous quantification of Imipenem (IPM) and Cilastatin (CSN) in injection formulations. These two drugs are utilized to combat bacterial infections, making their accurate determination in pharmaceuticals crucial. The newly established method has been validated for its efficiency, sensitivity, and precision, offering significant advantages over previously reported techniques.
Development and Validation of the HPLC Method
The RP-HPLC method was optimized using an Inertsil-ODS C18 column with a mobile phase consisting of methanol and acetonitrile in an 80:20 ratio. The flow rate was maintained at 1.0 mL/min, allowing for the separation of IPM and CSN within a total runtime of eight minutes. The retention time for IPM was 2.930 minutes, while CSN was 4.215 minutes. Method validation was performed following ICH guidelines, encompassing parameters such as linearity, precision, accuracy, and robustness. The linear range reported for both drugs was 20-80 µg/mL, with regression coefficients indicating excellent correlation.
Stress Degradation Studies
The stability-indicating nature of the method was assessed through stress degradation studies under various conditions: acidic, basic, oxidative, thermal, and photolytic. These studies aimed to provoke potential degradation pathways and ensure that the method could reliably separate ipm and CSN from their degradation products. The results indicated that neither of the drugs was adversely affected during these stress tests, with recovery rates remaining consistently high, affirming the method's robustness.
Application of the Method
The proposed RP-HPLC method was applied to analyze a commercially available injection formulation containing both IPM and CSN. The assay results demonstrated high accuracy, with mean recoveries close to the labeled claims for both drugs. The method's effectiveness was statistically verified using student t-tests and F-tests, supporting its precision and reliability for routine quality control analyses in pharmaceutical settings.
Conclusion
The developed RP-HPLC method for the simultaneous determination of Imipenem and Cilastatin is characterized by its rapid, simple, and accurate approach. Comprehensive validation confirms its suitability for routine application in quality control of pharmaceutical products. The ability to distinguish the drugs from degradation products reinforces the method's stability-indicating nature, facilitating enhanced reliability in ensuring the quality of injectable formulations containing these essential antibiotics.
FAQ section (important questions/answers):
What is the purpose of the developed RP-HPLC method?
The purpose of the developed RP-HPLC method is to simultaneously estimate Imipenem (IPM) and Cilastatin (CSN) in injection formulations while ensuring the method is stability-indicating and validated for quality control purposes.
What are the main components evaluated in the stability study?
The stability study evaluates the effects of various stress conditions including acid, base, oxidation, heat, and light on the degradation of Imipenem and Cilastatin.
What are the retention times for Imipenem and Cilastatin?
The retention times achieved during the RP-HPLC analysis were 2.930 minutes for Imipenem and 4.215 minutes for Cilastatin.
How was method validation conducted for the RP-HPLC method?
Method validation was conducted according to ICH guidelines, focusing on system suitability, linearity, sensitivity, accuracy, precision, ruggedness, and robustness to ensure reliability.
What results indicate the method's accuracy and precision?
The accuracy and precision of the method are supported by low %RSD values, acceptable recovery percentages, and good correlation coefficients across various tested concentrations.
Who funded or supported the research presented in the study?
The research received support from Hetero Pharmaceuticals, Pvt. Ltd. for providing drug samples, along with facilities from Acharya Nagarjuna University and NRI Institute of Technology.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “RP-HPLC method for simultaneous estimation of imipenem and cilastatin”. 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) Drug:
The term 'Drugs' is a plural form indicating multiple chemical compounds used for therapeutic purposes. In pharmaceuticals, drugs need to be analyzed for their quality, efficacy, and safety. The article focuses on the simultaneous estimation of two specific drugs, Imipenem and Cilastatin, demonstrating the importance of combining analytical techniques for regulatory compliance.
2) Table:
In the context of the article, 'Table' refers to a structured arrangement of data that summarizes research findings, such as system suitability tests, method validation results, and degradation studies. Tables help readers quickly grasp quantitative information, allowing for easier comparisons and analysis of the performance of the methodology being discussed.
3) India:
India is the country where the study was conducted, specifically mentioning institutions like Acharya Nagarjuna University and NRI Institute of Technology located in Andhra Pradesh. The Indian pharmaceutical industry is significant, contributing to global medicine supply, thus highlighting the relevance of developing reliable analytical methods for drug formulations within this region.
4) Study (Studying):
The term 'Study' refers to a systematic investigation designed to establish facts or principles or to collect information on a subject. In this article, the study revolves around the development and validation of a stability-indicating RP-HPLC method, emphasizing the importance of reliable methodologies in ensuring drug safety and efficacy in formulations.
5) Powder:
The word 'Powder' relates to the form in which the drugs (Imipenem and Cilastatin) are processed for analysis. Powders can undergo various procedures, such as dissolution and infusion in mobile phases for chromatography. In pharmaceutical settings, the nature of the powder is crucial for maintaining the stability and bioavailability of the drug components being studied.
6) Performance:
Performance in this context refers to the efficiency and effectiveness of the developed RP-HPLC method. Key performance indicators include resolution, detection sensitivity, precision, and reproducibility of the method when analyzing Imipenem and Cilastatin. High performance in analytical methods is critical for ensuring accurate measurement and compliance with pharmaceutical standards.
7) Nagarjuna:
Nagarjuna refers to Acharya Nagarjuna University, an institution involved in the research conducted in the article. The university plays a critical role in fostering academic research and development in the pharmaceutical sciences. The involvement of such institutions enriches the research landscape by providing resources, funding, and expertise in drug analysis.
8) Andhra (Amdhra):
Andhra pertains to Andhra Pradesh, the Indian state where the research was conducted. The region is notable for its growing pharmaceutical industry, providing a necessary backdrop for research in drug formulation and analysis. This geographical significance emphasizes the need for local regulatory compliant methodologies that enhance pharmaceutical quality control within the state.
9) Water:
Water, particularly in its 'Milli-Q' form, refers to highly purified water used in laboratory processes including sample preparation and mobile phase composition. The quality of water is essential in HPLC as it can directly affect the performance and reliability of analytical results. Using purified water minimizes potential contaminants that could interfere with drug analysis.
10) Relative:
The term 'Relative' often pertains to relative standard deviation (%RSD), a statistical measure used to assess the precision of experimental results. In analytical chemistry, maintaining low %RSD values demonstrates consistency in method results, highlighting reliability in quantifying drug concentrations. This ensures that findings are reproducible and valid.
11) Glass:
In the article, 'Glass' relates to laboratory equipment made from glass, such as petri dishes and volumetric flasks used for the preparation and storage of chemical substances. Glassware is crucial in analytical chemistry as it provides inert, non-reactive containers that ensure the integrity of the samples being handled.
12) Nakar:
Nagar is part of the name Nagarjuna, referencing Acharya Nagarjuna University, which is mentioned in the context of conducting significant pharmaceutical research. The university's contribution to analytical methods emphasizes the academic influence and richness of knowledge generated in the region concerning drug analysis and pharmaceutical development.
13) Babu:
Babu refers to a researcher or author in the context of previous studies cited within the article. The mention of Babu highlights collaborative research efforts and the foundation laid by previous studies in the field of pharmaceutical analysis. It showcases the cumulative knowledge built upon by scientists working in drug quantification.
14) Dish (Dis):
The term 'Dish' in this context likely refers to laboratory dishes, such as petri dishes, used in the study for various purposes including housing drug samples for degradation studies. Using dishes ensures controlled conditions for experiments and aids in the precise assessment of drug stability under different stress conditions.
15) Measurement:
Measurement pertains to the quantitative assessment of drug concentrations using the developed RP-HPLC method. Accurate measurement is vital in pharmaceuticals as it determines drug dosages and safety. The article emphasizes the method’s ability to measure Imipenem and Cilastatin efficiently and accurately, ensuring that pharmaceutical standards are met.
16) Vijayawada (Vijayavada, Vijaya-vada):
Vijayawada is referenced as a key location in Andhra Pradesh, India, where some of the contributing institutions to the study are situated. The city is significant in the pharmaceutical landscape of India, supporting research initiatives that aim to advance drug analysis methods which are crucial for the overall healthcare system.
17) Discussion:
Discussion in this context refers to the section of the article where the implications and significance of the research findings are examined. It provides insight into how the developed method enhances drug analysis, compares it against previous methodologies, and addresses its potential applications in routine pharmaceutical quality control.
18) Knowledge:
Knowledge in this article relates to the understanding and expertise garnered through research in pharmaceutical sciences, especially in drug analysis. The study contributes to the body of knowledge by validating a new analytical method, which could be beneficial for both academia and the pharmaceutical industry in improving drug formulation assessments.
19) Sandhya (Samdhya, Shandhya):
Sandhya refers to another researcher whose work is mentioned in the context of methodologies for drug quantification. Her contributions, along with others, enrich the literature and lend credibility to the analytical methods discussed in the article. It reflects the collaborative nature of scientific research in pharmaceuticals.
20) Quality:
Quality signifies the standard of the drug products being analyzed, ensuring they meet safety and efficacy requirements. In the pharmaceutical context, quality control is paramount, and the article stresses the importance of reliable analytical methods like the RP-HPLC for maintaining the quality of Imipenem and Cilastatin in formulations.
21) Nature:
Nature in the context of this article refers to the inherent qualities of the developed analytical method, such as its stability-indicating characteristics. Understanding the nature of a method allows researchers to know its limitations, applications, and the degree to which it can reliably measure drug concentrations in various conditions.
22) Blood:
The term 'Blood' indicates that prior methods assess drug concentrations in biological matrices such as blood plasma, important for pharmacokinetic studies. While this article focuses on injection formulations, the relevance of blood studies underscores the complex interplay of drug action in the body and the necessity for accurate monitoring of therapeutic drugs.
23) Rani:
Rani refers to another researcher within the referenced literature regarding methodologies for drug analysis. Similar to others mentioned, Rani's contributions help build a comprehensive knowledge database in drug quantification, showcasing diverse approaches to pharmaceutical analysis, which the article aims to review and improve upon with the new RP-HPLC method.