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- W2355824654 abstract "Objective To develop and validate a high-performance liquid chromatography (HPLC) method for the analysis of letrozole in human plasma and to study the relative bioavalability of letrozole dispersible tablets versus tablets. Method The liquid-liquid extraction of letrozole from plasma was performed with aether. the letrozole was chromatographed on a Diamonsil C18 column(4.6mm×200 mm, 5μm) with a mobile phase consisting of acetonitrile and phosphate buffer in the ratio of 41∶59v/v, the mobile phase was pumped at a ? ow rate of 1.0mL/min. Mizolastine was used as an internal standard and the eluents were monitered at 239nm by the ultraviolet absorption detector. The 18 healthy volunteers were received a single oral dose of 2.5mg dispersible tablets or tablets in a randomized crossover study. The letrozole concentration of collected plasma samples was determined by the novel HPLC method. Results The letrozole was eluted at 6.8min and well separated from co-extracted endogenous components and the internal standard. The method was linear over the range from 2.48~99.2μg/L(r=0.9994) and the limits of quantitation (LOQ) of letrozole is 2.48μg/L.The recovery was from87.88%~104.02%(n=20)and the intra-day and inter-day RSD were less than 10%(n=20). The relative bioavailability of dispersible tablets to tablets was (101.20±19.33)%. The 90% confidence intervals of the test/reference ratios were 95.1%~103.3% for Cmax, 90.5%~108.4% for AUC0-144 and 84.7%~112.1% for AUC0-∞. No statistically signif icant difference was found for Tmax. Conclusion A rapid, accurate, simple and sensitive HPLC method has been established for the assay of plasma letrozole concentration and the results of statistics showed there were no signif icant differences between the two preparations, so the bioequivalence was achieved." @default.
- W2355824654 created "2016-06-24" @default.
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- W2355824654 date "2010-01-01" @default.
- W2355824654 modified "2023-09-25" @default.
- W2355824654 title "HPLC Determination of Letrozole in Human Plasma and Study on Bioavalibility of Letrozole Dispersible Tablets" @default.
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