Scholarlink

Background <p>Linagliptin and Empagliflozin are widely used antidiabetic agents, and their combined dosage forms require reliable analytical methods for quality control. Conventional chromatographic method development often lacks robustness; therefore, the application of QbD principles ensures systematic optimization and enhanced method performance.</p> Methodology <p>In the QbD strategy, a central composite design (CCD) was employed to evaluate the influence of critical method parameters, particularly the composition of the mobile phase and the flow rate. The interaction effects of these parameters on critical responses, including retention time and resolution of Linagliptin and Empagliflozin, were analyzed using response surface plots to establish optimal chromatographic conditions. Chromatographic separation was achieved using a C18 column (250 × 4.6&#xa0;mm, 5&#xa0;μm) with an isocratic elution system. The mobile phase consisted of Methanol and Acetonitrile (90:10, v/v) delivered at a flow rate of 1 mL/min. Detection was carried out using a photodiode array (PDA) detector at 225&#xa0;nm.</p> Results <p>The method demonstrated good linearity over the concentration range of 2.5–12.5&#xa0;µg/mL for Linagliptin and 5–25&#xa0;µg/mL for Empagliflozin, with correlation coefficients (r²) of 0.993 and 0.991, respectively. The optimized method provided satisfactory resolution with 4.174&#xa0;min of Linagliptin and 2.900&#xa0;min for Empagliflozin retention times, and validation parameters confirmed that the method is precise, accurate, and reproducible.</p> Conclusion <p>The developed RP-HPLC method based on QbD principles is simple, robust, and reliable for the simultaneous estimation of Linagliptin and Empagliflozin in pharmaceutical dosage forms. The application of CCD and response surface methodology ensures systematic optimization and enhances method performance, making it suitable for routine quality control analysis.</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

Central composite design assisted optimization of RP-HPLC method for simultaneous estimation of linagliptin and empagliflozin using AQbD perspective

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年7月11日

查看全文
  • Khushbu Patel,
  • Zeel Modi,
  • Chhaganbhai N. Patel

摘要

Background

Linagliptin and Empagliflozin are widely used antidiabetic agents, and their combined dosage forms require reliable analytical methods for quality control. Conventional chromatographic method development often lacks robustness; therefore, the application of QbD principles ensures systematic optimization and enhanced method performance.

Methodology

In the QbD strategy, a central composite design (CCD) was employed to evaluate the influence of critical method parameters, particularly the composition of the mobile phase and the flow rate. The interaction effects of these parameters on critical responses, including retention time and resolution of Linagliptin and Empagliflozin, were analyzed using response surface plots to establish optimal chromatographic conditions. Chromatographic separation was achieved using a C18 column (250 × 4.6 mm, 5 μm) with an isocratic elution system. The mobile phase consisted of Methanol and Acetonitrile (90:10, v/v) delivered at a flow rate of 1 mL/min. Detection was carried out using a photodiode array (PDA) detector at 225 nm.

Results

The method demonstrated good linearity over the concentration range of 2.5–12.5 µg/mL for Linagliptin and 5–25 µg/mL for Empagliflozin, with correlation coefficients (r²) of 0.993 and 0.991, respectively. The optimized method provided satisfactory resolution with 4.174 min of Linagliptin and 2.900 min for Empagliflozin retention times, and validation parameters confirmed that the method is precise, accurate, and reproducible.

Conclusion

The developed RP-HPLC method based on QbD principles is simple, robust, and reliable for the simultaneous estimation of Linagliptin and Empagliflozin in pharmaceutical dosage forms. The application of CCD and response surface methodology ensures systematic optimization and enhances method performance, making it suitable for routine quality control analysis.