Volume : 12, Issue : 11, November – 2025
Title:
A COMPREHENSIVE REVIEW ON ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR METRONIDAZOLE AND CIPROFLOXACIN
Authors :
Sanchi A.Gaikwad*, Sandeep M. Ambore
Abstract :
Analytical method development and validation play a crucial role in ensuring the quality, safety, and efficacy of pharmaceutical formulations. Metronidazole and Ciprofloxacin are two widely prescribed antimicrobial agents that are often combined in dosage forms to achieve synergistic effects against a broad spectrum of infections. However, their simultaneous estimation presents analytical challenges due to differences in their chemical structures, polarity, and UV absorption characteristics. This review provides a comprehensive overview of the physicochemical and pharmacokinetic properties of both drugs, followed by an in-depth discussion of various analytical techniques developed for their estimation. Emphasis is placed on spectrophotometric, chromatographic (HPLC, HPTLC, LC-MS), and other instrumental approaches, highlighting method optimization parameters such as solvent selection, detection wavelength, mobile phase composition, and column selection. The review also summarizes critical validation parameters including accuracy, precision, linearity, specificity, sensitivity, robustness, and system suitability as per ICH guidelines. The comparative evaluation of these techniques demonstrates the importance of stability-indicating and validated analytical methods for ensuring reproducible quantification in routine quality control, formulation development, and pharmacokinetic studies. Overall, this review serves as a valuable reference for researchers and analysts engaged in the development of reliable, sensitive, and regulatory-compliant analytical methods for Metronidazole and Ciprofloxacin.
Keywords: Metronidazole, Ciprofloxacin, Analytical Method Development, Validation, HPLC, UV Spectrophotometry, ICH Guidelines, Stability-Indicating Methods.
Cite This Article:
Please cite this article in press Sanchi A. Gaikwad et al., A Comprehensive Review On Analytical Method Development And Validation For Metronidazole And Ciprofloxacin, Indo Am. J. P. Sci, 2025; 12(11).
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