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Development of Analytical Methods01:21

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An analytical methodology can be divided into four sequential steps: technique, method, procedure, and protocol. A technique is a scientific principle that rationalizes a specific phenomenon through chemical measurements. Adapting a technique for analyzing a sample of interest is termed a method. The procedure outlines the directions for performing the analysis via an analytical method. The protocol is the detailed guidelines on the procedure, which should be strictly followed to obtain the...
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HPLC Coupled with Chemical Fingerprinting for Multi-Pattern Recognition for Identifying the Authenticity of Clematidis Armandii Caulis
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Green analytical method development for statin analysis.

Amira Louiza Assassi1, Claude-Eric Roy1, Philippe Perovitch2

  • 1Université de Bordeaux, EA 4575 Analytical and Pharmaceutical Developments Applied to Neglected Diseases and Counterfeits, Bordeaux, France.

Journal of Chromatography. A
|January 14, 2015
PubMed
Summary
This summary is machine-generated.

A green analytical chemistry method using HPLC/DAD was developed for statin analysis. Optimized conditions achieved efficient separation and high solubility for potential buccal administration.

Keywords:
EthanolGreen analytical chemistrySolubilityStatinsVan Deemter

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Area of Science:

  • Analytical Chemistry
  • Green Chemistry
  • Pharmaceutical Analysis

Background:

  • Development of efficient analytical methods for statins is crucial for pharmaceutical quality control.
  • Exploring green analytical chemistry principles reduces environmental impact.
  • High-concentration statin formulations require investigation for novel drug delivery systems.

Purpose of the Study:

  • To develop and validate a green High-Performance Liquid Chromatography with Diode-Array Detection (HPLC/DAD) method for analyzing pravastatin, fluvastatin, and atorvastatin.
  • To optimize column parameters and mobile phase composition for efficient statin separation.
  • To assess the solubility of statins in hydro-alcoholic solutions for potential buccal administration.

Main Methods:

  • HPLC/DAD analysis utilizing an ethanol-based mobile phase and an octadecyl-grafted silica column.
  • Optimization of column parameters (particle size, type) and mobile phase composition (ethanol/formic acid).
  • Validation of the method for content determination in high-concentration hydro-alcoholic solutions and assessment of statin solubility.

Main Results:

  • An ODS-AQ YMC column (50 mm × 4.6 mm, 3 μm) with an ethanol/formic acid mobile phase (50:50, v/v) at 1 mL/min and 40°C provided optimal separation and efficiency.
  • The highest concentration respecting detector linearity was 0.5 mg/mL for sample preparation.
  • Pravastatin and fluvastatin exhibited solubility >100 mg/mL, while atorvastatin calcium salt had a maximum solubility of 2 mg/mL in specific ethanol-water mixtures; using atorvastatin improved solubility.

Conclusions:

  • The developed green HPLC/DAD method is suitable for the content determination of statins in highly concentrated hydro-alcoholic solutions.
  • Optimized statin solutions demonstrate potential for buccal Per-Mucous administration due to rapid drug passage.
  • This research contributes to greener analytical practices and explores innovative drug delivery avenues for statins.