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<p>To develop a reverse phase high performance liquid chromatography technique for the quantitative measurement of Imeglimin HCl, that is easy to use, fast, precise and stability-indicating. The Agilent 1260 Infinity II with UV Detector was used to develop the suggested RP-HPLC technique. The Kromasil C18, 250&#xa0;mm*4.6&#xa0;mm, 5µ column was used to accomplish the chromatographic separation. The temperature of the column was 40° C. The detection wavelength was 240&#xa0;nm, and the mobile phase flow rate was 1&#xa0;ml/min. Imeglimin HCl was subjected to a variety of stress conditions, including oxidative, acidic, basic, hydrolytic, thermal, and photolytic degradation.&#xa0;Imeglimin HCl was found to have a retention duration of 4.34&#xa0;min. The range of the drug’s linearity was 80–120&#xa0;µg/ml. Imeglimin HCl was found to undergo considerable degradation when exposed to base and peroxide stress. With the help of the ideal chromatographic conditions, the degradants were removed successfully from the drug. According to the International Conference on Harmonization’s Q2 (R1) requirements, the method developed was validated.&#xa0;The Forced degradation investigations confirmed the methods stability under different stress conditions. The validation parameters show how well the drug is separated from its degradants. Imeglimin HCl can be quantitatively determined in the quality control laboratory using the proposed method on a regular basis.</p>

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Stability Indicating RP-HPLC Method Development and Validation for Estimation of Imeglimin HCl

  • 期刊论文

  • 发表日期：

    2026年1月16日

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  • Kavita Bhushan Vikhe,
  • Sandeep Suresh Sonawane

摘要

To develop a reverse phase high performance liquid chromatography technique for the quantitative measurement of Imeglimin HCl, that is easy to use, fast, precise and stability-indicating. The Agilent 1260 Infinity II with UV Detector was used to develop the suggested RP-HPLC technique. The Kromasil C18, 250 mm*4.6 mm, 5µ column was used to accomplish the chromatographic separation. The temperature of the column was 40° C. The detection wavelength was 240 nm, and the mobile phase flow rate was 1 ml/min. Imeglimin HCl was subjected to a variety of stress conditions, including oxidative, acidic, basic, hydrolytic, thermal, and photolytic degradation. Imeglimin HCl was found to have a retention duration of 4.34 min. The range of the drug’s linearity was 80–120 µg/ml. Imeglimin HCl was found to undergo considerable degradation when exposed to base and peroxide stress. With the help of the ideal chromatographic conditions, the degradants were removed successfully from the drug. According to the International Conference on Harmonization’s Q2 (R1) requirements, the method developed was validated. The Forced degradation investigations confirmed the methods stability under different stress conditions. The validation parameters show how well the drug is separated from its degradants. Imeglimin HCl can be quantitatively determined in the quality control laboratory using the proposed method on a regular basis.