Volume : 12, Issue : 03, March – 2025
Title:
ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF RP-HPLC FOR ANTIBACTERIAL AGENT
Authors :
Shraddha V.Lipte, Suraj D.Sagrule, Dr.K.R.Biyani
Abstract :
The present study focuses on the development and validation of a robust Reverse Phase High Performance Liquid Chromatography (RP-HPLC) method for the accurate estimation of antibacterial agents in pharmaceutical formulations. In the era of increasing pharmaceutical competition and innovation, ensuring drug quality and safety is critical. Analytical method development is a fundamental aspect of pharmaceutical product development, especially in identifying and quantifying impurities that may pose toxicological risks. The method was optimized using suitable mobile phases and detection wavelengths, followed by rigorous validation as per ICH guidelines to assess parameters such as linearity, accuracy, precision, specificity, and robustness. This validated method is designed to effectively monitor the purity and potency of antibacterial agents, ensuring consistency in quality and compliance with regulatory standards. The study highlights the critical role of analytical testing in safeguarding public health by confirming the identity, strength, and purity of pharmaceutical substances.
Cite This Article:
Please cite this article in press Shraddha V.Lipte et al., Analytical Method Development And Validation Of RP-HPLC For Antibacterial Agent., Indo Am. J. P. Sci, 2025; 12(05).
Number of Downloads : 10
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