HPLC梯度洗脱法同时测定复方盐酸喹那普利／氢氯噻嗪片剂含量及有关物质

目的：建立HPLC法，同时测定复方盐酸喹那普利／氢氯噻嗪片剂中的主成分及其有关物质。方法：色谱柱为LichrospherC，8柱（250mm×4．6mm，5μm）；流动相为乙腈-0．05％三乙胺水溶液（用磷酸调pH至3．50），梯度洗脱；柱温为40℃；检测波长为215nm。主成分测定采用外标法，有关物质检查采用主成分1％自身对照法。结果：两主成分与其有关物质等5种化合物均能较好分离，相邻各峰间分离度均大于1．5；盐酸喹那普利和氢氯噻嗪的线性范围分别为0．708—63．72mg·L-1（r=0．9998）和0．758～68．22mg·L-1（r=0．9999）；复方片剂中盐酸喹那普利与氢氯噻嗪的含量均为标示量的95％～105％，有关物质含量均小于或等于0．8％。结论：本法简便快速、专属性强、灵敏度高、重复性好，可用于该复方片剂的含量测定和杂质检查。

Simultaneous Determination of the Content and Related Substances in Compound Tablets of Quinapril Hydrochloride and Hydrochlorothiazide by HPLC Gradient Elution Method

Objective： To develop a HPLC method for simultaneous determination of two main components and their related substances in compound tablets of quinapril hydrochloride and hydrochlorothiazide. Methods： A Lichrospher C18 column （250 mm ×4.6mm,5μm） and acetonitrile- 0. 05 % triethylamine aqueous solution（ pH 3.50 adjusted with phosphoric acid） as mobile phase were used at a column temperature of 40℃ and with a detection wavelength of 215 nm by gradient elution. The main components were determined by external standard method and the related substances were determined by 1% main component self-control method. Results： Complete separation was achieved for the five compounds： two main components and three their related substances, with a resolution of greater than 1.5 between the neighbouring peaks. The linear ranges were 0. 708 -63.72 mg·L-1（r = 0. 999 8） for quinarpril hydrochloride and 0. 758 --68.22 mg·L-1（ r = 0. 999 9） for hydrochlorothiazide, respectively. The contents of quinapril hydrochloride and hydrochlorothiazide were 95 %- 105 % and the those of related substances were less than or equal to 0. 8 %, respectively in the compound tablets. Conclusion： This method is simple, rapid, specific, sensitive, reproducible and practicable for the determination of the content and related substances in the compound tablets.