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High-Performance Liquid Chromatography: Elution Process01:05

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In High-Performance Liquid Chromatography (HPLC), the elution process is critical to the separation of analytes and the quality of chromatographic results. Elution describes how compounds move through the column and separate based on their interactions with the mobile and stationary phases. This process determines the resolution, peak shape, and retention times in the chromatogram, which are essential for identifying and quantifying components in complex mixtures. Understanding the elution...
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Ion-exchange chromatography, or IEC, is a technique for separating ions based on their affinity for the stationary phase. The stationary phase is a cross-linked polymer resin with covalently attached ionic functional groups. The functional groups can be either positively charged (cation exchangers) or negatively charged (anion exchangers). A cation exchanger consists of a polymeric anion and active cations, while an anion exchanger is a polymeric cation with active anions. The choice of...
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  11. Integrating Green Analytical Chemistry And Analytical Quality By Design: An Innovative Approach For Rp-uplc Method Development Of Ensifentrine In Bulk And Inhalation Formulations

Integrating green analytical chemistry and analytical quality by design: an innovative approach for RP-UPLC method development of ensifentrine in bulk and inhalation formulations

Mohan Goud Vanga1, Sarad Pawar Naik Bukke2, Praveen Kumar Kusuma3

  • 1Department of Pharmaceutical Analysis, Joginpally BR Pharmacy College, Hyderabad, Telangana, 500075, India.

BMC Chemistry
|March 16, 2025

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View abstract on PubMed

Summary
This summary is machine-generated.

A new analytical method quantifies Ensifentrine (EFT), a promising COPD treatment, using quality-by-design and green chemistry principles. This validated RP-UPLC method is sensitive, robust, and environmentally sustainable for pharmaceutical analysis.

Area of Science:

  • Analytical Chemistry
  • Pharmaceutical Sciences
  • Green Chemistry

Background:

  • Chronic Obstructive Pulmonary Disease (COPD) is a major global health concern exacerbated by environmental factors.
  • Ensifentrine (EFT) is an emerging inhaled dual phosphodiesterase PDE3 and PDE4 inhibitor for COPD management, targeting airway inflammation and improving lung function.

Purpose of the Study:

  • To develop and validate a novel quantification method for Ensifentrine (EFT).
  • To integrate Analytical Quality-by-Design (AQbD) and Green Analytical Chemistry (GAC) principles into method development.
  • To establish a sensitive, robust, and sustainable analytical technique for EFT in pharmaceutical applications.

Main Methods:

  • An Analytical Quality-by-Design (AQbD) framework utilizing Design-expert® software and a central composite design optimized the RP-UPLC method.
Keywords:
Analytical quality-by-design (AQbD)ChlorTox scaleComplexMoGAPIEnsifentrine

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  • Isocratic separation was achieved on an ACQUITY UPLC HSS C18 SB column with a mobile phase of 0.01 N KH2PO4 and acetonitrile (66.4:33.6 v/v) at ambient temperature.
  • Method validation followed ICH guidelines, assessing linearity, LOD, LOQ, and application to bulk and formulated Ensifentrine samples.

    • Main Results:

    • The optimized RP-UPLC method demonstrated excellent linearity (r² = 0.9997) within the 3.75-22.5 μg/mL range.
    • The method achieved a Limit of Detection (LOD) of 3.3 μg/mL and a Limit of Quantitation (LOQ) of 10 μg/mL.
    • The validated method was successfully applied to quantify Ensifentrine in bulk materials and pharmaceutical formulations, showing statistical significance.

    Conclusions:

    • A sensitive, robust, and validated RP-UPLC method for Ensifentrine quantification has been successfully developed by integrating AQbD and GAC principles.
    • The developed method adheres to ICH guidelines and demonstrates environmental sustainability, evaluated through various greenness assessment tools.
    • This study establishes a precedent for developing sustainable and efficient analytical methods in pharmaceutical sciences.
    RP-UPLC
    Sustainability in laboratories