International Journal of Pharmaceutics & Drug Research

Mr. Saurabh Mishra, Dr. Pushpendra Soni, Dr. Rajeev Malviya, Dr. Kapil Malviya

ABSTRACT

This research focuses on the development and validation of an analytical method for the estimation of the poorly water-soluble drug Empagliflozin (EGF) utilizing hydrotropic phenomena. The challenge of limited aqueous solubility associated with EGF necessitates innovative approaches to enhance its solubility for accurate and reliable analysis. Hydrotropy, a technique involving the use of hydrotropic agents to solubilize poorly water-soluble drugs, has been employed to address this challenge. The analytical method was developed with a focus on key parameters, including linearity, recovery, repeatability, day-to-day variation, analyst-to-analyst variation, and reproducibility. Linearity was established over the concentration range of 10-50 µg/ml. Recovery studies were conducted at three different levels (80%, 100%, and 120%) to assess the accuracy of the method. Repeatability, day-to-day variation, analyst-to-analyst variation, and reproducibility were evaluated to ensure the precision and robustness of the developed method. The method exhibited excellent linearity over the concentration range of 10-50 µg/ml, ensuring accurate quantification of EGF within this range. Recovery studies at three different levels (80%, 100%, and 120%) demonstrated high accuracy, with % RSD values ranging from 0.328% to 0.532%. These results indicate the reliability of the method for quantifying EGF in tablet formulations. Repeatability, day-to-day variation, analyst-to-analyst variation, and reproducibility studies demonstrated low %RSD values (ranging from 0.104% to 1.027%), indicating the precision and robustness of the developed method. The LOD and LOQ were found to be 0.15 µg/ml and 0.45 µg/ml, respectively, indicating the sensitivity of the method for detecting low concentrations of EGF.

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