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Related Concept Videos

High-Performance Liquid Chromatography: Types of Detectors01:15

High-Performance Liquid Chromatography: Types of Detectors

The role of the detectors in High-Performance Liquid Chromatography (HPLC) is to analyze the solutes as they exit from the chromatographic column. The detector recognizes the solute's property and generates corresponding electrical signals, which are converted into a readable graph of the detector's response versus elution time called a chromatogram at the computer. There are several types of HPLC detectors, each with its own advantages and limitations, depending on the analyte properties and...

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Green RP-UPLC Method for Simultaneous Determination of Cyclopentolate and Organic Impurities Using DoE and

Bandar R Alsehli1, Abdullah H Alluhayb2, Lateefa A Al-Khateeb3

  • 1Department of Chemistry, Faculty of Science, Taibah University, Al-Madinah Al-Munawarah 30002, Saudi Arabia.

International Journal of Analytical Chemistry
|September 25, 2025
PubMed
Summary

This study introduces a green and efficient RP-UPLC method for analyzing cyclopentolate (CLO) and its impurities. The optimized method provides accurate and reliable results for pharmaceutical quality control.

Keywords:
Box–BehnkenRP-UPLCcyclopentolateorganic impuritiessustainability assessment tools

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Area of Science:

  • Analytical Chemistry
  • Green Chemistry
  • Pharmaceutical Analysis

Background:

  • Green and white chemistry principles enhance sustainability and efficiency in chemical analysis.
  • Accurate analysis of cyclopentolate (CLO) and its impurities is crucial for pharmaceutical quality control.

Purpose of the Study:

  • To develop and validate a straightforward, sustainable, and efficient RP-UPLC method for simultaneous analysis of CLO and its organic impurities.
  • To assess the environmental impact and practicality of the developed method using sustainability tools.

Main Methods:

  • Optimization of RP-UPLC conditions using Box-Behnken design, evaluating mobile phase composition, pH, and temperature.
  • Simultaneous analysis of CLO and impurities in pure and ophthalmic solutions.
  • Validation of the method according to ICH guidelines.

Main Results:

  • An optimized RP-UPLC method was established with specific mobile phase (ethanol:buffer 65:25, v/v), pH 4.25, flow rate 0.3 mL/min, and temperatures (4°C sample, 25°C column).
  • The method demonstrated excellent linearity (R²=0.9998) and acceptable recoveries (±15%).
  • The analysis time for the main peak was approximately 3 minutes.

Conclusions:

  • The developed RP-UPLC method is reliable, fast, and eco-friendly for the routine quality control of anticholinergic agents like CLO.
  • The integration of green and white chemistry tools ensures a reduced environmental impact.
  • This method offers a practical solution for simultaneous determination of drugs and their impurities in pharmaceutical formulations.