基于近红外光谱测定复方盐酸阿米洛利片有效成分的含量  

Content Determination of Effective Components in Compound Amiloride Hydrochloride Tablets by Near Infrared Spectroscopy

作　　者：陈久艳[1,2] 方敏[3] 吴再珍[1] 杨宏[1] 周群刚[1,3] 谢洪平[1] 

机构地区：[1]苏州大学医学部药学院,江苏苏州215123 [2]苏州市立医院,江苏苏州215002 [3]苏州市中心血站,江苏苏州215006

出　　处：《中国药房》2013年第9期828-830,共3页China Pharmacy

摘　　要：目的:建立同时快速测定复方盐酸阿米洛利片中盐酸阿米洛利和氢氯噻嗪含量的方法。方法:在该复方制剂的近红外漫反射光谱与盐酸阿米洛利/氢氯噻嗪含量之间,利用偏最小二乘法分别建立该两组分的多元校正模型;根据模型结合该制剂的量测光谱,分别计算两组分的含量;同时与标准含量测定方法(高效液相色谱法)测定结果比较。结果:建立的盐酸阿米洛利和氢氯噻嗪的校正模型中,校正集相关系数均为0.9962,预测集相关系数分别为0.9902、0.9903,校正集的均方根残差分别为0.0252、0.1735,预测集均方根残差分别为0.0516、0.3548。2种方法含量测定结果一致。结论:建立的方法简单、快速、准确,实现了该制剂中两组分含量的快速、同时、直接测定。OBJECTIVE：To establish an analytical method for the fast and simultaneous determinations of amiloride hydrochloride and hydrochlorothiazide contained in Compound amiloride hydrochloride tablet.METHODS：The multivariate calibration models of the two effective components were established using the partial least squares method between the near infrared diffuse reflectance spectra of the compound and the content of amiloride hydrochloride or hydrochlorothiazide in the compound.Based on these two models,the contents of the effective components could be calculated by using the measured spectra of the compound,and compared with the results by HPLC methods.RESULTS：For the calibration models of amiloride hydrochloride and hydrochlorothiazide,the correlation coefficients for calibration sample sets were both 0.996 2,and the correlation coefficients for prediction sample sets were 0.990 2 and 0.990 3,respectively.The root mean square errors were 0.025 2 and 0.173 5 for the calibration sample sets,and root mean square errors were 0.051 6 and 0.354 8 for the predication sample sets,respectively.Results of 2 methods were same to each other.CONCLUSIONS：Established method is simple,rapid and accurate,and it could be applied to the fast,direct and simultaneous determination for 2 components.

关 键 词：近红外光谱 偏最小二乘法 盐酸阿米洛利 氢氯噻嗪 含量测定 

分 类 号：R927.2[医药卫生—药学]