中国药业Issue(11)：53-54,55,3.
高效液相色谱法测定盐酸度洛西汀肠溶胶囊中α－萘酚杂质含量
HPLC Determination of Impurity α-Naphthol Content in Duloxetine Hydrochloride Enteric-Coated Capsules
周宏艳 1罗斌 2王菁3
作者信息
- 1. 浙江众益制药股份有限公司，浙江 丽水 323000
- 2. 温州医科大学，浙江 温州 325000
- 3. 山东省临沂市平邑县食品药品监督管理局，山东 临沂 273300
- 折叠
摘要
Abstract
Objective To establish a HPLC method for determining the impurity α-naphthol content in Duloxetine Hydrochloride Enter-ic-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 sodium hy-droxide solution, taking 1 L of this solution, adding 10. 3 g of sodium 1-hexanesulfonate monohydrate, shaking up for complete dissolv-ing ) ( 13 :17 :70 ) , the flow rate was 1. 0 mL/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 × 10-3 μg ( 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.关键词
高效液相色谱法/盐酸度洛西汀/α-萘酚/含量测定Key words
HPLC/duloxetine hydrochloride/determination of α-naphthol/determination分类
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周宏艳,罗斌,王菁..高效液相色谱法测定盐酸度洛西汀肠溶胶囊中α－萘酚杂质含量[J].中国药业,2015,(11):53-54,55,3.
