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

ABSTRACT

Objective To establishe an HPL C method to determine the dissolution of progesterone nanocrystal capsule. Methods The dissolution was determined by the first method described in Chinese pharmacopoeia (ChP) 2010. Totally 900 ml of 0.25% sodium lauryl sulfate solution were used as dissolution media, and the rotation speed was 75 r/min. The dissolution time was 45 min and the dissolution was determined by HPLC. The HPLC column was Agilent TC C18 column (150 mm×4.6 mm,5μm). 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℃and the injection volume was 20 μl. 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 determination of progesterone nanocrystal capsule.