Accelerated Stability Study, Swing Study and Photostability Study on Terbinafine Hydrochloride Creams

摘要

Accelerated stability study, swing study and photostability study had been performed on terbinafine hydrochloride creams by using stability-indicating RP HPLC method. Accelerated stability study had been performed according to WHO requirements. Samples of terbinafine hydrochloride cream were tested for any physical change, pH value and content of active ingredient. The results showed that there was no change in physical characteristics and small and acceptable changes of pH value had been noticed and the potency loss from the initial assay value did not exceed 5%. Swing study had been performed on terbinafine hydrochloride samples and the results were the same as accelerated stability study. A photostability study had been performed according to ICH requirements and the result showed that there was 14% potency loss from the initial assay value.