Definitive Review of Analytical Methods Reported on Estimation of Azelnidipine
Review Article
Keywords:
Azelnidipine, UV-Spectroscopy, RP- HPLC, HPTLC, Validation, ICH GuidelinesAbstract
Azelnidipine, classified as a dihydropyridine calcium channel blocker, is utilized in the management of hypertension and angina pectoris. The ongoing tasks across research and development, quality control, and quality assurance departments involve creating and validating analytical methods. These methods play a crucial role in risk management and equivalency assessments, facilitating the establishment of acceptability standards specific to a product and ensuring consistent outcomes. Validation ensures that the analytical process aligns with its intended purpose. Literature review indicates that analytical techniques such as UV spectroscopy, RP-HPLC, and HPTLC can be employed to determine Azelnidipine individually or in combination with other medications. These techniques are assessed for accuracy, precision, robustness, and other parameters according to ICH guidelines. They can be applied to both bulk and tablet dosage form analysis of Azelnidipine due to their simplicity, sensitivity, and repeatability. This comprehensive review not only discusses various analytical methods available for Azelnidipine analysis but also evaluates their suitability and limitations. Researchers focusing on Azelnidipine can gain valuable insights from this study, enhancing their comprehension of the analytical methods for estimation of the drug
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