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Simultaneous HPLC and derivative spectrophotometry detrmination of tioconazole and benzyl alcohol in bulk and cream with tioconazole forced degradation study

Ramzia I.El-Bagary, Ehab F.Elkady1, Marwa H.Tammam, Ayman Abo El maaty

Newhigh performance liquid chromatographic (HPLC) and derivative spectrophotometric methods have been developed and validated for the simultaneous determination of tioconazole and benzyl alcohol in bulk and cream dosage form. The firstmethod involved the use of chromatographic system composed of methanol: water (0.2%v/v, aqueous tri ethyl amine at pH 7.5) (85:15, v/v) as amobile phase at a flowrate 1mlmin-1 at ambient temperature with a Hypersil BDS-C18 (250 mm×4.6 mm, 5µm) column as a stationary phase. Quantitative determination of tioconazole and benzyl alcohol was achieved with UV detection at 210 nm and 220 nm, respectively. Linearity, accuracy and precision were found to be acceptable over the concentration range of (2–64ìg ml–1) for tioconazole and (8–192ìg ml–1) for benzyl alcohol. This chromatographic system was utilized to study the effect of acid and alkali hydrolysis, oxidation, thermal and photo-degradation on tioconazole stability. The second method involved the use of first order derivative spectrophotometry with the zero-crossing technique. Quantitative determination of tioconazole and benzyl alcohol was achieved by measuring amplitude at 233.4nm and 217.8 nm respectively. Linearity, accuracy and precision were found to be acceptable over the concentration range of (3–9 ìg ml–1) for tioconazole and (5–14 ìg ml–1) for benzyl alcohol. The optimized methods proved to be specific, precise and accurate for the quality control of the cited drugs in pharmaceutical preparations.