In this study, we report the synthesis of Ag NPs by green synthesis process using Datura metel leaf extract as reducing agent. The final products characteristics were studied – optical, structural, surface morphology and elemental analysis.
Silver Nanoparticle has been recognized as a safe inorganic, antibacterial, nontoxic agent. Conventional synthesis of Silver Nanoparticle can generate toxic waste during the reaction process hence, this paper the green synthesis approach used and for synthesis of silver nanoparticle by using Datura metel leaf extract as a reducing agent. The change in colour of silver nitrate solution from colourless to brown was visual identification for formation of Silver Nanoparticle and shown the absorption at 447 nm. The synthesized Silver Nanoparticle were of size 180 nm analyse by SEM and further characetrised by FTIR where carboxylic peak was obtained at 1675 cm-1 as well as presence of alcoholic group and polyphenols. Further validated method was developed and linearity was found to be 0.995 and % RSD of validation parameters were found to be within the limit <2%.
A simple, lab scale, rapid, accurate, precised and sensitive spectroscopic method has been developed and validated as per ICH guideline for synthesized silver nanoparticle in bulk pharmaceuticals by UV vis spectrophotoscopy and which is applicable for routine analysis.
Table of Contents
1. MATERIALS AND METHODS
1.1 Materials
1.2 Method for synthesis of Ag NPs
1.3 Characterization of synthesized Ag NPs
1.4 Method development
1.4.1 Preparation of Standard Stock Solution
1.4.2 Preparation of Working solution
1.5 Method Validation
1.5.1 Specificity
1.5.2 Linearity and range
1.5.3 Accuracy
1.5.4 Precision
1.5.5 Interday and Intraday precision
1.5.6 Limit of detection
1.5.7 Limit of quantification
1.5.8 Ruggedness
2. RESULTS
2.1 Synthesis of Ag NPs
2.2 Spectrum Analysis
2.3 FTIR Analysis
2.4 Surface Morphological studies
2.5 Method Validation
2.5.1 Validation Parameter
2.5.1.1 Specificity
2.5.1.2 Linearity and range
2.5.1.3 Accuracy
2.5.1.4 Precision
2.5.1.5 Limit of detection(LOD)
2.5.1.6 Limit of quantification(LOQ)
2.5.1.7 Ruggedness
3. DISCUSSION
Research Objective and Core Topics
The primary objective of this research is to develop an environmentally friendly, cost-effective green synthesis method for silver nanoparticles (Ag NPs) using Datura metel leaf extract, followed by the development and validation of a rapid and sensitive UV-Visible spectrophotometric analytical method for the routine quantification of these nanoparticles in bulk pharmaceutical applications.
- Green synthesis of silver nanoparticles using Datura metel leaf extract.
- Characterization of synthesized Ag NPs using UV-Vis spectroscopy, FTIR, and SEM.
- Development of a UV spectrophotometric analytical method.
- Validation of the analytical method according to ICH guidelines (Q2 R1).
- Evaluation of method performance metrics: linearity, accuracy, precision, LOD, and LOQ.
Excerpt from the Book
Method for synthesis of Ag NPs:
Datura metel leaves were freshly collected. To remove the soil and other contaminants present on the surface of fresh leaves, thoroughly washed with de-ionized water. After the wash, 10 g of leaves were cut into the small pieces and then soaked into 100 mL de-ionized water. These leaves were continuously stirred at 60 °C for 10 min and further filtered to get the extract. The plant extract was stored in refrigerator at 4 °C for the further use. 5 mL leaf extract was added drop by drop with 9 mM aqueous solution of silver nitrate (Ag NO3). The reaction mixture of Ag NO3 and leaf extract was stirred for 15 min to get colloidal solution of brown colour. The reduction process of Ag+ ions to Ag0 takes place, completely within the period of 15 min and observed visually by varying the initial colour of the reaction mixture from colourless to dark brown[2].
Summary of Chapters
MATERIALS AND METHODS: This chapter outlines the preparation of silver nanoparticles via green synthesis using leaf extract and describes the instrumentation and specific protocols used for their characterization and the development of a UV-Visible analytical method.
RESULTS: This section presents the empirical findings regarding the successful synthesis of Ag NPs and the comprehensive validation data for the developed spectroscopic method, including linearity, precision, and recovery studies.
DISCUSSION: The discussion interprets the synthesis efficiency and characterization results, concluding that the developed analytical method is a reliable, economical, and validated tool suitable for routine pharmaceutical quality control.
Keywords
Silver nanoparticle, Datura metel leaves, UV spectrophotometer, method development, validation, ICH guideline, green synthesis, surface plasmon resonance, FTIR spectroscopy, SEM characterization, pharmaceutical analysis, bulk drugs.
Frequently Asked Questions
What is the core focus of this research paper?
The research focuses on the green synthesis of silver nanoparticles using plant extracts and the establishment of a validated analytical method for their quantification in bulk pharmaceuticals.
Which plant extract is utilized in the synthesis process?
Datura metel leaf extract is used as the biological reducing and capping agent for the synthesis of silver nanoparticles.
What is the primary objective regarding method development?
The primary objective is to develop a sensitive, accurate, and rapid UV-Visible spectrophotometric method that conforms to ICH guidelines for routine analysis.
Which scientific techniques are employed for characterizing the nanoparticles?
The study utilizes UV-Visible spectroscopy for wavelength analysis, Fourier Transform Infrared (FTIR) spectroscopy for functional group analysis, and Scanning Electron Microscopy (SEM) for morphological examination.
What validation parameters were assessed for the method?
The method was validated for specificity, linearity, range, accuracy, precision (intraday and interday), limit of detection (LOD), limit of quantification (LOQ), and ruggedness.
How is the quality and reliability of the method demonstrated?
The reliability is demonstrated by achieving a high correlation coefficient (R2 = 0.995) and maintaining validation metrics such as percentage RSD well within the required limit of <2%.
Why is the green synthesis approach preferred over conventional chemical methods?
Green synthesis is preferred because it avoids the use of toxic chemicals and passivators, offering an environmentally friendly, cost-effective, and safe alternative.
What role does the UV spectrophotometer play in this study?
It is used both for the initial characterization of the silver nanoparticle suspension (confirming peak absorption at 447 nm) and as the primary analytical tool for determining nanoparticle concentration.
- Arbeit zitieren
- U. M. Patel (Autor:in), 2019, Green synthesis of silver Nanoparticles and its method development and validation by UV spectroscopy in bulk pharmaceuticals, München, GRIN Verlag, https://www.grin.com/document/1419236
