Content determination of dutasteride and antioxidant butylated hydroxy toluene in dutasteride soft capsules by HPLC / 中国药学杂志

ABSTRACT

OBJECTIVE: To establish a high performance liquid chromatography method to determine the contents of dutasteride soft capsules. METHODS: The chromatographic analysis was performed on a Phenomenex C18(Luna,4.6 mm × 150 mm, 3.0μm) column. The mobile phase was gradiently eluted. The flow rate was 1.0 mL < min-1. The detection wavelength was set at 240 and 285 nm, and the injection volume was 50 μL RESULTS: The linear ranges of dutasteride and butylated hydroxy Toluene (BHT) were 9.785-36.693 and 0.679-2.545 μg< mL-1, and the recoveries of this method were 99.9% and 102% with RSDs of 0.9% and 3.6%, respectively. CONCLUSION: This assay is proved to be simple, specific, and accurate. It can be effectively applied in the quality control of dutasteride soft capsules.