CAJ | 학술논문

目的：建立高效液相色谱法测定伊潘立酮原料药的含量。方法采用Dikma Diamonsil C18色谱柱（250 mm ×4．6 mm，5μm）；以乙腈：0．2 mol/L甲酸铵（50∶50）为流动相；柱温45℃；检测波长：275 nm；流速：1．0 ml/min。结果本法线性范围为50．55～141．54μg/ml（r＝0．9999），精密度、重复性、溶液稳定性的RSD均小于2％，检测限10 ng/ml（S/N＝3），定量限30 ng/ml（S/N＝10）。结论本法适用于伊潘立酮原料药的含量测定。
목적：건립고효액상색보법측정이반립동원료약적함량。방법채용Dikma Diamonsil C18색보주（250 mm ×4．6 mm，5μm）；이을정：0．2 mol/L갑산안（50∶50）위류동상；주온45℃；검측파장：275 nm；류속：1．0 ml/min。결과본법선성범위위50．55～141．54μg/ml（r＝0．9999），정밀도、중복성、용액은정성적RSD균소우2％，검측한10 ng/ml（S/N＝3），정량한30 ng/ml（S/N＝10）。결론본법괄용우이반립동원료약적함량측정。
Objective To establish a method for determination of the content in iloperidone drug substance by HPLC .Methods HPLC was performed on a Dikma Diamonsil C 18 chromatographic column with the mobile phase of 0.2mol/L ammonium formate-acetonitrile( 50∶50) at a flow rate of 1.0mL/min ; the column temperature was 45 ℃,and the detection wavelength was 275 nm.Results The liner range of calibration curve for iloperidone was 50.55 ~141.54μg/ml ( r =0.999 9), the RSD of precision, repeatability and the solution stability were below 2%;the limit of detection was 10 ng/mL , the limit of quantitation was 30 ng/ml. Conclusions The established method is suitable for determination of the content in iloperidone drug substance .