Patel Dipti B, Patel N J, Patel S K, Prajapati A M, Patel S A
S. K. Patel College of Pharmaceutical Education & Research, Department of Pharmaceutical Chemistry, Ganpat University, Kherva-382 711, India.
Indian J Pharm Sci. 2010 Jan;72(1):113-6. doi: 10.4103/0250-474X.62247.
A simple, sensitive and precise RP-HPLC method was developed for the determination of dutasteride in tablet dosage form. The RP-HPLC separation was achieved on phenomenex C(18) column (250 mm, id 4.6 mm, 5 mum) using mobile phase methanol:water (90:10 v/v) at a flow rate of 1 ml/min at an ambient temperature. Quantification was achieved with photodiode array detection at 235 nm over the concentration range 1-12 mug/ml. The method was validated statistically and was applied successfully for the determination of dutasteride in tablets.
建立了一种简单、灵敏、准确的反相高效液相色谱（RP-HPLC）法，用于测定片剂剂型中的度他雄胺。采用phenomenex C(18) 柱（250 mm，内径4.6 mm，5μm）进行RP-HPLC分离，流动相为甲醇:水（90:10 v/v），流速为1 ml/min，柱温为室温。在235 nm波长下，采用光电二极管阵列检测，在1-12μg/ml的浓度范围内进行定量分析。该方法经统计学验证，并成功应用于片剂中度他雄胺的测定。
