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Abstract: To evaluate the relative bioavailability of anethole trithione (ATT) from self-microemulsifying drug delivery system (SMEDDS) and tablet, a sensitive, accurate and reliable liquid chromatography method was developed and validated to determine ATT in rabbit plasma. Chromatographic separation was performed on a Diamonsil C18 column by using a mixture of methanol–water (90:10, v/v) delivered at a flow rate of 1.0ml/min. The wavelength was set at 348nm and mifepristone was used as the internal standard. A linear relationship for ATT was found in the range of 0.5–32ng/ml. The mean extraction recoveries of ATT determined over three concentrations were 84.7±5.8, 92.3±3.4 and 89.9±5.1%. After administration of SMEDDS and tablets to rabbits, significant differences were found in main pharmacokinetic parameters of T max, C max and AUC0–∞ between these two formulations, and a 2.5-fold enhancement of relative bioavailability of ATT was observed from the SMEDDS compared with tablets. [Copyright &y& Elsevier]

Abstract: A isocratic, selective, accurate and stability indicating HPLC method of analysis of nelfinavir mesylate both as a bulk drug and in formulations was developed and validated. A CN chromatographic column (250mm×4.6mm, 5μm) was used for the separation at 40°C. The mobile phase consisted of a mixture of acetonitrile (MeCN) and 25mM monobasic ammonium phosphate (containing 25mM triethylamine, pH 3.4 with phosphate acid) (40:60, v/v) was delivered at a flow rate of 1.0ml/min with detection at 210nm. The developed method was validated in terms of selectivity, linearity, limit of quantitation, precision, accuracy and solution stability. As the proposed LC method achieved satisfactory resolution between nelfinavir mesylate, its degradation products, intermediate product possibly present in nelfinavir drug substance and other impurities in the end product before refining in the final step of synthetic process, it can be employed as a stability indicating one, used for the synthetic process control and determination of nelfinavir mesylate in pharmaceutical preparations. [Copyright &y& Elsevier]

Abstract: To evaluate the bioavailability of puerarin sustained release tablet (SR-Tab.) and Yufengningxin tablet (YU-Tab.), a liquid chromatography method was developed and validated to determine puerarin in dog plasma. Chromatographic separation was performed on Diamonsil C18 column using a mixture of methanol–acetic acid–water (25:6:69, v/v/v) delivered at a flow rate of 1.0ml/min and detected by UV. 4-Hydroxybenzaldehyde was used as the internal standard. The linear range for puerarin was from 60 to 1800ng/ml (r =0.9991) with a limit of quantitation of 60ng/ml. Within-day accuracy and precision ranged from −3.0 to 2.2% and from 1.2 to 4.3%, between-day accuracy and precision ranged from −4.1 to 2.6% and from 1.3 to 5.7%, respectively. The mean extraction recoveries of puerarin determined over the three concentrations were (90.3±5.2)%, (95.7±1.4)% and (93.1±3.5)%. A significant difference was observed in main pharmacokinetic parameters of T max, C max and AUC0–∞ between puerarin SR-Tab. and YU-Tab. in dogs. The smoother plasma concentrations were obtained from SR-Tab. in dogs and the results were as expected. [Copyright &y& Elsevier]