Hegazy M A, Yehia A M, Moustafa A A
Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Egypt.
Pharmazie. 2013 May;68(5):317-26.
The ability of bivariate and multivariate spectrophotometric methods was demonstrated in the resolution of a quaternary mixture of mosapride, pantoprazole and their degradation products. The bivariate calibrations include bivariate spectrophotometric method (BSM) and H-point standard addition method (HPSAM), which were able to determine the two drugs, simultaneously, but not in the presence of their degradation products, the results showed that simultaneous determinations could be performed in the concentration ranges of 5.0-50.0 microg/ml for mosapride and 10.0-40.0 microg/ml for pantoprazole by bivariate spectrophotometric method and in the concentration ranges of 5.0-45.0 microg/ml for both drugs by H-point standard addition method. Moreover, the applied multivariate calibration methods were able for the determination of mosapride, pantoprazole and their degradation products using concentration residuals augmented classical least squares (CRACLS) and partial least squares (PLS). The proposed multivariate methods were applied to 17 synthetic samples in the concentration ranges of 3.0-12.0 microg/ml mosapride, 8.0-32.0 microg/ml pantoprazole, 1.5-6.0 microg/ml mosapride degradation products and 2.0-8.0 microg/ml pantoprazole degradation products. The proposed bivariate and multivariate calibration methods were successfully applied to the determination of mosapride and pantoprazole in their pharmaceutical preparations.
在莫沙必利、泮托拉唑及其降解产物的四元混合物的分离中,证明了双变量和多变量分光光度法的能力。双变量校准包括双变量分光光度法(BSM)和H点标准加入法(HPSAM),它们能够同时测定这两种药物,但在存在其降解产物时则不能。结果表明,采用双变量分光光度法时,莫沙必利在5.0 - 50.0μg/ml浓度范围内、泮托拉唑在10.0 - 40.0μg/ml浓度范围内可同时测定;采用H点标准加入法时,两种药物在5.0 - 45.0μg/ml浓度范围内均可同时测定。此外,应用的多变量校准方法能够使用浓度残差增强经典最小二乘法(CRACLS)和偏最小二乘法(PLS)测定莫沙必利、泮托拉唑及其降解产物。所提出的多变量方法应用于17个合成样品,其中莫沙必利浓度范围为3.0 - 12.0μg/ml,泮托拉唑浓度范围为8.0 - 32.0μg/ml,莫沙必利降解产物浓度范围为1.5 - 6.0μg/ml,泮托拉唑降解产物浓度范围为2.0 - 8.0μg/ml。所提出的双变量和多变量校准方法成功应用于其药物制剂中莫沙必利和泮托拉唑的测定。