HPLC梯度洗脱法测定硝苯地平氢氯噻嗪片中两组分的含量

摘要

OBJECTIVE To establish a method for determination of nifedipine,hydrochlorothiazide in nifedip-ine Hydrochlorothiazide Tablets.METHODS The chromatographic column was DIONEX Acclaim 120 C18 column (4.6mm ×250mm,5μm) ,the mobile phase was 0.1mol・ L-1 sodium dihydrogen phosphate ( value to 3.0 ±0.1 with phosphoric acid to regulate pH ) acetonitrile gradient elution, flowrate:1.0 mL・ min-1 , column temperature:30℃;the detection wavelength was 230 nm.RESULTS The linear range for nifedipine and hydrochlorothiazide were 4.01~64.16μg・ mL-1(r=1.0000) and 8.04~128.70μg・ mL-1(r=0.9999),the average recovery rate were 99.82%(RSD=0.89%) and 99.53%(RSD=0.97%).CONCLUSION The methodis accurate,reliable,sim-ple,and suitable for the quality control of nifedipine,hydrochlorothiazide in nifedipine Hydrochlorothiazide Tablets.%目的：建立HPLC法同时测定硝苯地平氢氯噻嗪片中硝苯地平、氢氯噻嗪含量的方法。方法色谱柱为 DIONEX Acclaim 120 C18柱（4．6mm ×250mm，5μm），流动相为0．1mol・ L －1磷酸二氢钠（用磷酸调节pH值至3．0±0．1）－乙腈梯度洗脱，流速：1．0mL・ min －1，柱温：30℃；检测波长为230nm。结果硝苯地平、氢氯噻嗪的线性范围分别为4．01～64．16μg・ mL －1（r＝1．0000）、8．04～128．70μg・ mL －1（r＝0．9999），平均回收率分别为99．82％（ RSD＝0．89％），99．53％（ RSD＝0．97％）。结论建立的方法准确、可靠，简单易行，适用于硝苯地平氢氯噻嗪片中硝苯地平、氢氯噻嗪的质量控制。