CAJ | 학술논문

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=0.9976），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。
목적：건립용우염산도락서정장용효낭중α－내분잡질측정적고효액상색보（HPLC）법。방법색보주위Agilent C8주(150 mm ×4.6 mm，3.5μm )，류동상위을정－정병순－완충액（배제2.9 g/L린산용액，용경양화납용액조절pH지2.5，취해용액1 L，가입10.3 g일수기완광산납，요균，사완전용해，13：17：70），류속위1.0 mL/min，검측파장위230 nm，주온위40℃。결과α－내분적진양량재8×10－4～8×10－3μg범위내여봉면적정량호적선성관계（ r=0.9976），평균회수솔위99.25%，RSD위0.89%（ n=9）。결론해법전속성강、내용、준학，가용우염산도락서정장용효낭중α－내분적측정。
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.