CAJ | 학술논문

目的：建立青蒿素哌喹片中哌喹的含量测定及有关物质的检测方法，并建立哌喹有关物质限度。方法：采用高效液相色谱法，色谱柱为SHISEIDO CAPCELL PAK C18（4.6 mm伊250 mm，5滋m），以乙腈颐0.1%三氯乙酸溶液颐三乙胺（18颐82颐0.2，磷酸调节pH至2.5）为流动相，柱温为30益，流速为1.0 mL·min-1，检测波长为216 nm（有关物质测定）和237 nm（含量测定）。结果：哌喹与各主要杂质及强制破坏产生的降解产物的杂质峰均分离良好，哌喹在0.01-0.2 mg·mL-1范围内与峰面积线性关系良好，R2=0.9999，回收率为98.14%（RSD=0.77%，n=9），最低检出限为0.06滋g·mL-1，供试品溶液在12 h内稳定。结论：该方法专属性强，准确、灵敏，可用于青蒿素哌喹片中哌喹含量测定和有关物质检测。
목적：건립청호소고규편중고규적함량측정급유관물질적검측방법，병건립고규유관물질한도。방법：채용고효액상색보법，색보주위SHISEIDO CAPCELL PAK C18（4.6 mm이250 mm，5자m），이을정이0.1%삼록을산용액이삼을알（18이82이0.2，린산조절pH지2.5）위류동상，주온위30익，류속위1.0 mL·min-1，검측파장위216 nm（유관물질측정）화237 nm（함량측정）。결과：고규여각주요잡질급강제파배산생적강해산물적잡질봉균분리량호，고규재0.01-0.2 mg·mL-1범위내여봉면적선성관계량호，R2=0.9999，회수솔위98.14%（RSD=0.77%，n=9），최저검출한위0.06자g·mL-1，공시품용액재12 h내은정。결론：해방법전속성강，준학、령민，가용우청호소고규편중고규함량측정화유관물질검측。
This study was aimed to establish determination method of content and related substances of piperaquine in A rtemisinin and Piperaquine Tablets, and to set the limit of related substance. HPLC was adopted on a SHISEIDO CAPCELL PAK C18 (4.6 mm í 250 mm, 5 μm) using an isocratic mobile phase consisted of acetonitrile: 0.1%trichloroaceticacid:triethylamine (18:82:0.2, V:V:V, pH 2.5) with a flow rate of 1.0 mL·min-1. The column tempera-ture was kept at 30oC and the detection wavelength was set at 216 and 237 nm, separately for the determination of related substance and content. The results showed that piperaquine and its related impurity can be separated effec-tively. The concentration-response relationship was linear over the range of 0.01-0.2 mg·mL-1 (R2=0.999 9). The av-erage recovery rate was 98.14% (RSD=0.77%, n=9). The minimum detection limit was 0.06 μg·mL-1. The solution was stable for 12 h. It was concluded that the method was specific, accurate, sensitive and suitable for the determi-nation of content and related substances of piperaquine in A rtemisinin and Piperaquine Tablets.