摘要
A rapid, accurate and sensitive HPLC method for the determination of bupropion hydrochloride in a new tablet formulation is described. Chromatographic separation of bupropion hydrochloride is achieved using a mobile phase consisting of methanol -0.01 mol·L -1 ammonium dihydrogen phosphate (80:20, v/v, pH 4.8) at a flow rate of 1.0 mL·min -1 on a Hypersil BDS C18 column. Absorbance is monitored at 251 nm where bupropion hydrochloride has maximum absorption in the mobile phase. The linear range of determination for bupropion hydrochloride is between 2.12 and 21.2 μg·mL -1. The proposed method was validated with respect to accuracy, precision, limits of detection and quantification and robustness, etc.
本文建立了一种用于新药盐酸安非他酮片含量测定的HPLC法 ,并就方法的线性、准确性、精密度、检测限和定量限及耐用性等对测定方法进行了认证。采用C1 8色谱柱 ,以甲醇 - 0 0 1mol·L 1 磷酸二氢铵 (80 :2 0 ,v/v ,pH 4 8)为流动相 ,流速为 1 0mL·min 1 ,检测波长为 2 5 1nm。线性范围为 2 12 - 2 1 2 μg·mL 1 (r =0 9999,n =5 ) ,平均回收率为 99 6 (RSD =0 7% ,n =9) ,日内和日间精密度分别为 0 5 % (n =3)和 0 8% (n =9)。本法快速、准确 。
