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Summary This study explored the stability and degradation products of aloin A under varying pH, temperature and light conditions usually encountered in processing. The stability of aloin A was significantly affected by temperature and pH. The content of aloin A decreased by more than 90% within 12 h at 50 °C and within 6 h at 70 °C, respectively. A significant decrease in stability was also observed at higher pHs. At pH 8.0, less than 2% of aloin A remained within 12 h. However, aloin A exhibited good stability at acidic pH levels with 94% remaining at pH 2.0 for 14 days. Light exerted no influence on the stability during the experimental period (14 days). Aloe‐emodin, elgonica‐dimers A and B were characterised as major degradation products of aloin A at pH 5.0 or below, and elgonica‐dimers were mainly formed at 4 °C as well. 10‐hydroxyaloins A and B were found under any condition except at pH 2.0 and 3.0, and they were mainly formed under high temperature, neutral‐basic and any light conditions.

A liquid chromatography/tandem mass spectrometry (LC/MS/MS) method was developed and validated for the determination of donepezil in human plasma samples. Diphenhydramine was used as the internal standard. The collision-induced transition m/z 380 --> 91 was used to analyze donepezil in selected reaction monitoring mode. The signal intensity of the m/z 380 --> 91 transition was found to relate linearly with donepezil concentrations in plasma from 0.1-20.0 ng/mL. The lower limit of quantification of the LC/MS/MS method was 0.1 ng/mL. The intra- and inter-day precisions were below 10.2% and the accuracy was between -2.3% and +2.8%. The validated LC/MS/MS method was applied to a pharmacokinetic study in which healthy Chinese volunteers each received a single oral dose of 5 mg donepezil hydrochloride. The non-compartmental pharmacokinetic model was used to fit the donepezil plasma concentration-time curve. Maximum plasma concentration was 12.3 +/- 2.73 ng/mL which occurred at 3.50 +/- 1.61 h post-dosing. The apparent elimination half-life and the area under the curve were, respectively, 60.86 +/- 12.05 h and 609.3 +/- 122.2 ng . h/mL. LC/MS/MS is a rapid, sensitive and specific method for determining donepezil in human plasma samples.

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