Development and Validation of UV Spectroscopic Method for Estimation of Fluconazole in Tablet Dosage Form

American Journal of PharmTech Research

article

Dinesh B. Kamdi¹  Hina M. Yerne¹  Swapnil R. Patil² 

[1] Department of Quality Assurance, Vidya Bharati College of Pharmacy, Amravati University;Department of Pharmaceutics, Vidya Bharati College of Pharmacy, Amravati University

关键词: Fluconazole;    Development;    UV Spectrophotometer;    Melting Point;    Assay Method;    Validation;    Accuracy;    Linearity;    Ruggedness;    Precision;   

DOI  :  10.46624/ajptr.2020.v10.i1.008

学科分类：药学

来源: American Journal Of Pharmtech Research

【 摘 要 】

To develop and validate simple, rapid, linear, accurate, precise and economical UV Spectroscopic method for estimation of Fluconazole in tablet dosage form. The drug is freely soluble in organic solvents such as ethanol, DMSO, and dimethyl formamide. The drug was identified in terms of solubility studies and on the basis of melting point done on Melting Point Apparatus of Equiptronics. It showed absorption maxima were determined in Ethanol. The drug obeyed the Beer’s law and showed good correlation of concentration with absorption which reflect in linearity. The UV spectroscopic method was developed for estimation of Fluconazole in tablet dosage form and also validated as per ICH guidelines. The drug is freely soluble in organic solvents such as Ethanol, DMSO, and Dimethyl Formamide. So, the Analytical Grade Ethanol is used as a diluent in method. The melting point of Fluconazole was found to be 139-140˚C (uncorrected). It showed absorption maxima 252 nm in Ethanol. On the basis of absorption spectrum the working concentration was set on 60µg/ml (PPM). The linearity was observed between 20-100 μg/ml (PPM). The results of analysis were validated by recovery studies. The recovery was found to be 98.75, 101.00 and 100.83% for three levels respectively. The % RSD for precision was found to be 0.78%. A simple, rapid, linear, accurate, precise and economical UV Spectroscopic method has been developed for estimation of Fluconazole in tablet dosage form. The method could be considered for the determination of Fluconazole in quality control laboratories.

【 授权许可】

Others