Simultaneous Determination of Ticlopidine Hydrochloride and Nitrendipine in a New Tablet Formulation by HPLC  

HPLC法同时测定制剂中盐酸噻氯吡啶和尼群地平的含量(英文)

作　　者：齐美玲[1] 王鹏[2] 顾峻岭[1] 

机构地区：[1]北京理工大学化工与材料学院,北京100081 [2]沈阳华泰药物研究所,沈阳110015

出　　处：《Journal of Beijing Institute of Technology》2002年第4期378-382,共5页北京理工大学学报（英文版）

摘　　要：An accurate, simple and sensitive high performance liquid chromarographic (HPLC) method for simultaneous determination of ticlopidine hydrochloride and nitrendipine in a new tablet formulation is described. Chromatographic separation of ticlopidine hydrochloride and nitrendipine was achieved on a Hypersil BDS C18 column using a mobile phase consisting of acetonitrile-methanol-10 mmol/L ammonium acetate (60∶10∶30(V/V), pH 6.5) at a flow rate of 1.0 mL/min. Absorbance was monitored at 236 nm where both drugs have significant absorption. The proposed method was validated with respect to linearity, selectivity, accuracy, precision, and limits of detection and quantitation. The linear ranges for ticlopidine hydrochloride and nitrendipine were found to be 75-750 μg/mL and 1-10 μg/mL, respectively. The mean recoveries were 100.1%(S R=0.6%,n=9) for ticlopidine hydrochloride and 99.9%(S R=0.7%,n=9) for nitrendipine. The within-day precision and between-day precision for ticlopidine hydrochloride and nitrendipine were 0.63% and 0.89%, and 0.74% and 1.0%, respectively. The proposed HPLC method can be used for the simultaneous determination of both drugs in pharmaceutical preparations.建立了一种HPLC法 ,用于制剂中盐酸噻氯吡啶和尼群地平的含量测定 ,并就方法的选择性、准确性、精密度、检测限和定量限等对方法进行了认证 .采用C18色谱柱 ,以乙腈 甲醇 醋酸铵 ( 60∶10∶3 0 (V/V) ,pH 6 5 )为流动相 ,流速为 1 0mL/min ,检测波长为 2 3 6nm .盐酸噻氯吡啶和尼群地平含量测定的线性范围为 75～ 75 0 μg/mL(R =0 9999,n =5 )和 1～ 10 μg/mL (R =0 9999,n =5 ) ;平均回收率分别为 10 0 1% (SR=0 6% ,n =9)和99 9% (SR=0 7% ,n =9) ;日内精密度分别为 0 63 %和 0 74% ,日间精密度分别为 0 89%和 1 0 0 % .本法快速、准确、选择性高 ,可用于药物制剂中盐酸噻氯吡啶和尼群地平的同时测定 .

关 键 词：HPLC DETERMINATION ticlopidine hydrochloride NITRENDIPINE 

分 类 号：O657.7[理学—分析化学]