CAJ | 학술논문

目的考察多潘立酮的浓度对于多潘立酮有关物质测定的影响。方法岛津wondaSil TM ，C18色谱柱；以甲醇∶0．5％醋酸铵水溶液（67∶33）为流动相，检测波长为280 nm，柱温30℃，通过改变进样体积（5、10、20、30μL）和不同浓度（5、2．5、1．25、0．9、0．7、0．5、0．2 mg/mL）的多潘立酮溶液，进行有关物质的测定。结果进样体积增加，有关物质有所增加，且相对保留时间为0．372、1．133的有关物质增加显著，增加比例分别为198．32％和99．68％；不同浓度进行检查，结果均小于1．0％，但在检出杂质峰的数量上有明显差异。结论不同浓度对于多潘立酮有关物质的检查有一定的影响，本研究可以作为多潘立酮有关物质检查时供试品浓度选择的参考依据。
목적고찰다반립동적농도대우다반립동유관물질측정적영향。방법도진wondaSil TM ，C18색보주；이갑순∶0．5％작산안수용액（67∶33）위류동상，검측파장위280 nm，주온30℃，통과개변진양체적（5、10、20、30μL）화불동농도（5、2．5、1．25、0．9、0．7、0．5、0．2 mg/mL）적다반립동용액，진행유관물질적측정。결과진양체적증가，유관물질유소증가，차상대보류시간위0．372、1．133적유관물질증가현저，증가비례분별위198．32％화99．68％；불동농도진행검사，결과균소우1．0％，단재검출잡질봉적수량상유명현차이。결론불동농도대우다반립동유관물질적검사유일정적영향，본연구가이작위다반립동유관물질검사시공시품농도선택적삼고의거。
Objective To observe the effects of different concentrations of Domperidone on its related substances . Methods HPLC was adopted for this study .The chromatographic colum was wondaSil TM C18 (4.6 mm ×250 mm, 5 μm).The mobile phase consisted of 0.5%ammonium acetate solution-methanol ( 33∶67);detecting wavelength at 280 nm;the temperature was 30 ℃.The injection volume was 5,10,20,30 μL,and the concentrations was 5,2.5, 1.25,0.9,0.7,0.5,0.2 mg/mL.Results The related substances has increased as the injection volume increased , and the relative retention time of 0.372,1.133 of the related substances increased significantly ,increase the proportion respectively:198.32%,99.68%;Different concentrations for inspection results are less than 1.0%,but there was an obvious difference in the number of impurity peaks .Conclusion The effects of the various concentrations of Domp-eridone on its related substances was obvious ,which can provide the basis for the the concentrations selection of Domp-eridone .