Aditi Chouksey*
Nimita Manocha
Gurmeet Chhabra
Pharmaceutical analysis plays a crucial role in ensuring the quality, safety, and efficacy of bulk drug substances and their formulations. Among the various analytical techniques available, High-Performance Liquid Chromatography (HPLC) has emerged as one of the most reliable and versatile tools for both qualitative and quantitative analysis in the pharmaceutical industry.[1,2] The data generated through HPLC can be either numerical, representing the exact amount of a compound present in a sample, or qualitative, confirming the presence or absence of specific analytes.[3,4] Owing to its high sensitivity, accuracy, and reproducibility, HPLC is employed at every stage of drug development from the analysis of raw materials to in-process controls and final product testing.[5,6] The specific objective of each analysis depends on the nature of the sample and the stage of pharmaceutical development. Therefore, a clear understanding of the fundamental principles of chromatography is essential to comprehend the operation and applications of HPLC in pharmaceutical analysis. In this research work, Fluconazole was selected as the model drug because it is a widely used triazole antifungal agent employed in the treatment of various systemic and superficial fungal infections. Despite its extensive clinical use, the available analytical methods for Fluconazole are often reported in combination with other drugs or involve complex mobile phase systems containing buffers or multiple solvents, which make them less suitable for routine analysis. Several analytical methods for the estimation of Fluconazole have been previously reported in the literature; however, most of these methods involve complex mobile phase compositions, buffer systems, or drug combinations, which limit their simplicity and routine applicability. Therefore, the present study aimed to develop a simple, reliable, and eco-friendly RP-HPLC method for the quantitative estimation of Fluconazole as a single drug component. Multiple optimization trials were performed using different ratios of Water and Acetonitrile as the mobile phase to achieve a sharp, symmetrical peak with an acceptable retention time and minimal tailing. The use of a this mobile phase not only reduced the organic solvent consumption but also made the method more environmentally friendly, cost-effective, and suitable for routine quality control analysis. Fluconazole, α-(2.4-diflurofenil)-α-(1H-triazol-1- methyl)-1H-1,2,4-triazol-1-ethano an antifungal medication, was discovered and developed by Pfizer. [7,8] Fluconazole is a first-generation triazole antifungal medication. It differs from earlier azole antifungals (such as ketoconazole) in that its structure contains a triazole ring instead of an imidazole ring. [9,10] The presence of a triazole and a difluoro phenyl produces potent antifungal activity but replacement of the usual imidazole group by triazole leads to improved selectivity.[11,12] Fluconazole is much less lipophilic than other azole antifungals and this leads to excellent penetration throughout the body, low protein-binding and water-solubility.[13,14] Fluconazole, was chosen for development on the basis of an optimal combination of antifungal efficacy, pharmacokinetic characteristics, aqueous solubility, and safety profile.[15]
10.5281/zenodo.17553037