Журнал хроматографии и методов разделения
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Development and Validation of a New Chromatographic Method for the Estimation of Vismodegib by RP-HPLC

Pulusu VS*, Kommarajula P

An analytical method using high performance liquid chromatography equipped with photodiode array detector (HPLC-PDA) was developed and validated for estimation of Vismodegib as per ICH and FDA guidelines. Mobile phase consisted 0.1% Orthophosphoric acid: Acetonitrile (50:50, v/v) pumped at flow rate of 1.0 mL /min, in isocratic mode and detector was set at 264 nm. The method was validated in terms of the precision, linearity, accuracy, degradation and robustness. The detector response of Vismodegib is directly proportional to concentration ranging from 0.012-0.120 mg/mL and the mean recovery was 99.6% (RSD=0.19%, n=9). In the intra-and inter assay, the percentage difference was found to be less than 2%. Robustness was proved performing variation in mobile phase, flow rate and column temperature. A forced degradation study of Vismodegib was conducted under the condition of acidic, basic, thermal, peroxide, photo and hydrolysis. Vismodegib was found to be degraded (water bath at 60°C for 2 hours) in peroxide stress. The result of the study showed that the proposed method is simple, fast, precise and accurate, which is useful for the routine determination of Vismodegib in bulk and dosage forms.