Dissolution detection of progesterone nanocrystal capsule by HPLC / 国际药学研究杂志

ABSTRACT

Objective To establish an HPLC method to determine the dissolution of progesterone nanoerystal eapsule. Methods The dissolution was determined by the first method described in Chinese pharmacopoeia (ChP) 2010. Totalis 900 ml of 0.25% sodium lauryl sulfate solution were used as dissolution media, and the rotation speed was 75 r/min. The dissolution lime was 45 min and the dissolution was determined by HPLC. The HPLC column was Agilent TC C18 column (150 mm×4.6 mm.5 µ.rn). The mobile phase was methanol-acetonitrile-water (35-40-25, V/V/V), with a flow rate of 1.0 ml/min and the detection wavelength of 241 nm. The column temperature was 25°C and the injection volume was 20 µ1. Results The average recovery of the method was about 100.02%(n=15 ), and the stability of working solutions was acceptable in 24 h (RSD=0.92%, n=8). The calibration curves showed good linearity (r= 1,n=6) within ranges of 2.78-66.7 µg/ml. Conclusion The method is convenient and sensitive in the dissolution letermination ol progesterone nanncrvstal capsule.