A Simple TLC Method for Analysis of Fluconazole in Pharmaceutical Dosage Forms

Use of an internal standard is proposed in this thin-layer chromatographic determination of fluconazole in tablet and capsule formulations. Determination of drugs in commercial formulations requires dilution, which is a serious source of analytical errors. It is known that an internal standard, if properly chosen, can help to eliminate this type of problem. This method, which was established and validated using clotrimazole as internal standard, is based on HPTLC separation of the two compounds on silica gel 60 GF 254 , with toluene-chloroform-methanol 1.2:3.0:0.4 ( v/v ) as mobile phase, followed by densitometric measurement of the spots at 210 nm. The retention factors for fluconazole and clotrimazole were 0.25 ± 0.024 and 0.62 ± 0.022 respectively. The response to fluconazole, either peak height and peak area, was a linear function of amount in the range 0.6–1.6 μg per band, with a constant amount of the IS. The method was validated for accuracy, precision, specificity, and linearity. Results from tabl...