Scholarlink

<p>A simple, efficient, and environmentally sustainable hydrophilic interaction liquid chromatography (HILIC)–HPLC method was developed and validated for the simultaneous quantification of vildagliptin and remogliflozin in bulk drug substances and pharmaceutical dosage forms. These highly polar antidiabetic agents present analytical challenges in conventional reversed-phase HPLC due to poor retention and early elution. The proposed HILIC approach effectively overcomes these limitations by providing improved retention, peak symmetry, and resolution. Chromatographic separation was achieved on a silica-based HILIC column using an isocratic mobile phase consisting of acetonitrile and 1 mM sodium octane sulfonate buffer (90:10, v/v), with pH adjusted to 3.2 using orthophosphoric acid, at a flow rate of 0.5 mL/min, with UV detection at 223&#xa0;nm. Vildagliptin and remogliflozin were well resolved with retention times of 3.561 and 5.391&#xa0;min, respectively, and these values have been verified and standardized across all sections, figures, and chromatograms. The method was validated in accordance with ICH Q2(R2) (November 2023) guidelines and demonstrated excellent linearity (r² &gt; 0.998), accuracy (98–102%), precision (%RSD &lt; 2%), robustness, and specificity. The limits of detection and quantification were 0.10 and 0.30&#xa0;mg/mL for vildagliptin and 0.12 and 0.40&#xa0;mg/mL for remogliflozin, respectively. Owing to low buffer concentration, reduced solvent consumption, and short analysis time, the method exhibits a favorable green analytical profile. The validated method is suitable for routine quality-control analysis of polar antidiabetic formulations.</p> Graphical Abstract <p></p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Sustainable analytical approach for determination of multiple polar antidiabetic drugs using HILIC-HPLC

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年6月2日

查看全文
  • Pranita Jirvankar,
  • Surendra Agrawal

摘要

A simple, efficient, and environmentally sustainable hydrophilic interaction liquid chromatography (HILIC)–HPLC method was developed and validated for the simultaneous quantification of vildagliptin and remogliflozin in bulk drug substances and pharmaceutical dosage forms. These highly polar antidiabetic agents present analytical challenges in conventional reversed-phase HPLC due to poor retention and early elution. The proposed HILIC approach effectively overcomes these limitations by providing improved retention, peak symmetry, and resolution. Chromatographic separation was achieved on a silica-based HILIC column using an isocratic mobile phase consisting of acetonitrile and 1 mM sodium octane sulfonate buffer (90:10, v/v), with pH adjusted to 3.2 using orthophosphoric acid, at a flow rate of 0.5 mL/min, with UV detection at 223 nm. Vildagliptin and remogliflozin were well resolved with retention times of 3.561 and 5.391 min, respectively, and these values have been verified and standardized across all sections, figures, and chromatograms. The method was validated in accordance with ICH Q2(R2) (November 2023) guidelines and demonstrated excellent linearity (r² > 0.998), accuracy (98–102%), precision (%RSD < 2%), robustness, and specificity. The limits of detection and quantification were 0.10 and 0.30 mg/mL for vildagliptin and 0.12 and 0.40 mg/mL for remogliflozin, respectively. Owing to low buffer concentration, reduced solvent consumption, and short analysis time, the method exhibits a favorable green analytical profile. The validated method is suitable for routine quality-control analysis of polar antidiabetic formulations.

Graphical Abstract