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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 .
A HPLC method was established for the determination of ticlopidine hydrochloride and nitrendipine in the preparation and the method was validated for selectivity, accuracy, precision, limit of detection and limit of quantification.Using C18 The mobile phase consisted of acetonitrile and methanolic ammonium acetate (60:10:30 (V / V), pH 6 5) with a flow rate of 10 mL / min and a detection wavelength of 236nm. The linear range of the determination of the mean linear range was 75-75 0 μg / mL (R = 0 9999, n = 5) and 1-10 μg / mL (R = 0 9999, n = 5) (SR = 0 6%, n = 9) and 99 9% (SR = 0 7%, n = 9). The intra-day precision was 0 63% and 0 74% respectively. The daytime precision was 0 89% And 100% .The method is rapid, accurate and selective and can be used for the simultaneous determination of ticlopidine and nitrendipine in pharmaceutical preparations.