Development and validation of different UV-spectrophotometric methods for the estimation of fluconazole in bulk and in solid dosage form

Abstract

A simple, sensitive and accurate UV-spectrophotometric method has been developed for the determination of an antifungal drug, fluconazole (FLZ), in raw material and in tablets. The drug shows maximum absorption at 261 nm in selected four different simulated media, namely gastric fluid simulant (HCl), vaginal fluid simulant (VFS), phosphate buffer (PB) and phosphate buffer saline (PBS) at <i style="">p</i>H 1.5, 4.2, 6.8 and 7.4 respectively. Beer’s law is obeyed in the concentration range 10-100 <img src='/image/spc_char/micro.gif' border=0>g/mL of drug. The limits of detection have been calculated for different media, such as HCl, VFS, PB and PBS and are found to be 2.24, 1.49, 1.42 and 1.19 <img src='/image/spc_char/micro.gif' border=0>g/mL, whereasthe limits of quantification are 6.82, 4.50, 4.29 and 3.63 <img src='/image/spc_char/micro.gif' border=0>g/mL correspondingly. The methods have been successfully applied to the determination of FLZ in tablets and bulk drug. Results are validated statistically as per ICH guidelines. It is found that the excipients present in the commercial formulation do not interfere with the methods and hence the UV-method permits a rapid and economical quantification of drug in bulk and in tablet dosage form.