An endurable RP-UPLC method for assessing total impurities in candesartan cilexetil tablets: Evaluating greenness and whiteness
Bandar R. Alsehli, Ammena Y. Binsaleh, Samar M. Mahgoub, Mahmoud A. Mohamed, Sayed M. Saleh, Abdullah H. Alluhayb
Abstract
Abstract The identification and control of toxic impurities are vital components of patient safety. Impurities may adversely affect a drug's potency as well as cause adverse reactions. A drug's therapeutic effectiveness depends on maintaining acceptable levels of impurities. A study was conducted to develop four sustainability tools with a green-and-white metric approach. These tools are designed to investigate the potential environmental impacts of innovative and straightforward RP-UPLC strategies used for simultaneous analysis and separation of the drug and its impurities in their pure form. The calibration curves for candesartan cilexetil and impurity B, impurity C, impurity D, impurity E, and impurity F from 0.00020–0.0101, 0.00101–0.0505, 0.00103–0.0514, 0.000975–0.0487, 0.00102–0.0511, and 0.00102–0.0512 mg mL −1 exhibited a correlation value exceeding 0.9998. The recovery ±15% of the actual amount, which is considered acceptable. ICH guidelines thoroughly validate the recommended approach for analyzing newly developed formulations, ensuring their high reliability. A technique that can estimate antihypertension drugs and their impurities simultaneously using RP-UPLC has been successfully developed. Green and white metrics were used to assess this approach's environmental sustainability.