摘要
目的建立用于盐酸度洛西汀肠溶胶囊中α-萘酚杂质测定的高效液相色谱（HPLC）法。方法色谱柱为Agilent C8柱（150 mm×4.6 mm,3.5μm）,流动相为乙腈-正丙醇-缓冲液（配制2.9 g/L磷酸溶液,用氢氧化钠溶液调节pH至2.5,取该溶液1 L,加入10.3 g一水己烷磺酸钠,摇匀,使完全溶解,13∶17∶70）,流速为1.0 mL/min,检测波长为230 nm,柱温为40℃。结果α-萘酚的进样量在8×10^-4-8×10^-3μg范围内与峰面积呈良好的线性关系（r=0.997 6）,平均回收率为99.25%,RSD为0.89%（n=9）。结论该法专属性强、耐用、准确,可用于盐酸度洛西汀肠溶胶囊中α-萘酚的测定。
Objective To establish a HPLC method for determining the impurity α-naphthol content in Duloxetine Hydrochloride Enteric-Coated Capsules.Methods The chromatographic column was the Agilent C8 column（150 mm × 4.6 mm,3.5 μm） with the mobile phase of acetonitrile-propanol-buffer solution（2.9 g/L phosphoric acid solution was prepared,adjusting pH to 2.5 with sodiumhydroxide solution,taking 1 L of this solution,adding 10.3 g of sodium 1-hexanesulfonate monohydrate,shaking up for complete dissolving）（13 ∶ 17 ∶ 70）,the flow rate was 1.0 m L/min,the detection wavelength was set at 230 nm and the column temperature was 40 ℃.Results The injection volume of α-naphthol in the range of 8 × 10^-4-8 × 10^-3μg（r = 0.997 6） showed the good linear relation with the peak area.The average recovery rate was 99.25%,RSD = 0.89%（n = 9）.Conclusion The established HPLC method is strongly specific,durable and accurate,can be used for the α-naphthol determination in Duloxetine Hydrochloride Enteric-Coated Capsules.
出处
《中国药业》
CAS
2015年第11期53-55,共3页
China Pharmaceuticals
