Dissolution detection of testosterone undecanoate capsule in vitro / 国际药学研究杂志

ABSTRACT

Objective To determin the dissolution of testosterone undecanoate capsule in vitro with an established HPLC method. Methods The dissolution was determined by the second method described in China(ChP) 2015, Pharmacopoeia. Totally 900 ml of 0.25% sodium lauryl sulfate solution with pH 6.8 phosphate buffer were used as dissolution media, and the rotation speed was 75 r/min. The dissolution time was 120 min and the dissolution was determined by HPLC. The HPLC column was phenomenex@ C18 column(250 mm×4.6 mm, 5µm). The mobile phase was 2-propanol-acetonitrile-water (454510, V/V/V) with a flow rate of 1.0 ml/min and the detection wavelength of 240 nm. The column temperature was 40°C and the injection volume was 20 µl. Results The average recovery of the method was about 100.55% (n=9). The calibration curves showed good linearity(r2=0.9999, n=7) within ranges of 1- 50 µg/ml. Conclusion The method is convenient and sensitive in the dissolution determination of testosterone undecanoate capsule.