CAJ | 학술논문

目的：依《中国药典》所述盐酸二甲双胍肠溶胶囊含量测定的方法，对盐酸二甲双胍肠溶片含量测定方法进行研究。方法：采用C18（4.6 mm×250 mm，5μm）色谱柱，流动相为0.05%庚烷磺酸钠溶液（用10%的磷酸溶液调节pH值至4.0）-乙腈（84∶16），柱温：30℃，检测波长232 nm。结果：盐酸二甲双胍在2.335～37.36μg/mL范围内线性关系良好，r=0.9999，平均回收率为100.34%（n=9）。结论：药典所述肠溶胶囊的含量测定方法简便准确，灵敏度高，专属性好，不仅能够用于肠溶胶囊的测定，同时也能够用于盐酸二甲双胍肠溶片的质量控制。
목적：의《중국약전》소술염산이갑쌍고장용효낭함량측정적방법，대염산이갑쌍고장용편함량측정방법진행연구。방법：채용C18（4.6 mm×250 mm，5μm）색보주，류동상위0.05%경완광산납용액（용10%적린산용액조절pH치지4.0）-을정（84∶16），주온：30℃，검측파장232 nm。결과：염산이갑쌍고재2.335～37.36μg/mL범위내선성관계량호，r=0.9999，평균회수솔위100.34%（n=9）。결론：약전소술장용효낭적함량측정방법간편준학，령민도고，전속성호，불부능구용우장용효낭적측정，동시야능구용우염산이갑쌍고장용편적질량공제。
Objective:To study the method of determinating the content of metformin hydrochloride enteric-coat-ed tablets by RP-HPLC according to the method set forth in theChinesePharmacopoeiafor metformin hydrochloride enteric-coated capsules.Methods:Chromatographic column of Hypersil ODS C18(4.6 mm×250 mm, 5μm)was used with the mobile phase of 0.05% heptane solution of sodium(10% phosphoric acid solution adjusted to pH 4.0)-acetonitrile(84∶16). The detection wavelength was at 232 nm and the column temperature was at 30 ℃.Results:There was a good linear relationship when the sample size was within the range of 2.335 ~37.36μg/mL(r= 0.999 9). The average recovery was 100.34%(n= 9).Conclusion:The content determination method for the capsules is convenient, fast and reproducible, it can also be used for the content determination of metformin hydrochloride en-teric-coated tablets.