UPLC-UV method for determination of risedronate in human urine.

This study was designed to develop a sensitive and rapid method for the quantitation of risedronate in human urine using ultra-performance liquid chromatography with ultra-violet detector (UPLC-UV) and to compare bioavailability parameter of 5, 35 and 150 mg risedronate. The mobile phase consisted of sodium phosphate buffer, 1 mM etidronate-acetonitrile (95:5, v/v), pH 9.0, and was pumped at a flow rate of 0.3 mL/min. Detection of risedronate in human urine by the UPLC-UV was accurate and precise from 20 ng/mL to 5 μg/mL (a correlation coefficient of 0.99) with 97.16% in mean recovery. The intra-day accuracy was 89.17-110.43% with precision of 0.04-3.16% and the inter-day accuracy was 89.23-110.19% with precision of 1.63-9.72%. Aet (accumulated excretion amount) of risedronate in the urine after 5, 35 and 150 mg administration was 35.08, 246.67 and 1.413.85 μg within 36 h and Umax (maximal excretion rate) was 12.11, 77.7 and 374.24 μg/h, respectively. The assessed dose proportionality of Umax and Aet with three single doses of risedronate was found in an approximately linear manner. These results indicate that the developed simple, rapid and robust assay enables the complete processing of large samples for pharmacokinetic studies of risedronate in biological fluid.