HPLC法测定氯沙坦钾-氢氯噻嗪复方分散片中药物及有关物质的含量  

Determination of the contents of drugs and related substances in losartan potassium-hydrochlorothiazide dispersible tablets by HPLC

作　　者：陈凤菊[1] 李燕[1] 李建文[2] 潘长琦[1] 刘晓红[1] 何仲贵[1] 

机构地区：[1]沈阳药科大学药学院,辽宁沈阳110016 [2]华瑞制药有限公司,北京100005

出　　处：《沈阳药科大学学报》2009年第6期460-465,共6页Journal of Shenyang Pharmaceutical University

摘　　要：目的建立测定氯沙坦钾—氢氯噻嗪复方分散片中药物及有关物质含量的HPLC法。方法将2种主药与适宜的辅料混合制备成分散片，采用Kromasil C8柱（150mm×4．6mm，5μm），磷酸盐缓冲液（20mmol·L^-1磷酸氢二钠1000mL与20mmol·L^-1磷酸二氢钾600mL混合，pH值7．2）为流动相A，乙腈为流动相B进行梯度洗脱，流速1．0mL·min^-1，柱温40℃，检测波长280nm。结果2种主药及5种有关物质能够完全分离，氯沙坦钾质量浓度在100—600mg·L^-1内、氢氯噻嗪质量浓度在25～150mg·L^-1内与峰面积呈良好的线性关系，精密度RSD分别为0．16％、0．34％，重复性RSD分别为1．5％、2．6％。样品在12h内稳定，回收率分别为101．8％（RSD=1．8％）、101．1％（RSD=1．3％），该方法能准确定量主药成分。结论该方法专属性强、稳定可靠，适用于氯沙坦钾-氢氯噻嗪复方分散片的药物含量测定及有关物质检查。Objective To develop a reversed phase high performance liquid chromatography gradient elution method for the determination of the contents and related substances in losartan potassium-hydrochlorothiazide dispersible tablets. Methods The two drugs and suitable adjuvant were mixed to prepare the dispersible tablets. The chromatographic separations were accomplished on C8 column（4.6 mm×150 mm,5 μm）at 40 ℃ with a flow rate of 1.0 mL.min^-1 ,phosphate buffer（pH 7.2）-acetonitrile was used as mobile phase,a gradient elution was performed. The detection wavelength was set at 280 nm. Results The compounds were separated well, the linearities between peak areas and concentrations were observed in the range of 100 - 600 mg.L^-1 for losartan potassium with r =0. 999 8 ,and 25 - 150 mg.L^-1 for hydrochlorothiazide with r = 0. 999 8. The average recovery was 101.8% and 101.1%, with RSD of 1.8% and 1.3%, respectively. Conclusions The reversed phase high performance liquid chromatography gradient elution method is specific and stable for the determination of the contents and the related substances in losartan potassium-hydrochlo- rothiazide dispersible tablets.

关 键 词：氯沙坦钾 氢氯噻嗪 分散片 含量测定 有关物质 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]