ABSTRACT
Objective: To develop a model for rapid and non-destructive determination of amoxilcillin sodium and sulbactam sodium for injection using the analysis of near infrared diffuse reflectance spectroscopy (NIR) and chemometrics.Methods: Totally 41 batches of commercial samples and 20 batches of laboratory samples were analyzed by NIR and the legal methods.The first derivative and vector normalization were selected as the preprocessing methods and 8 720-5 446 cm-1 was selected as the frequency range.Results: The quantitative model was constructed based on 16 batches of commercial samples and 15 batches of laboratory samples (0.75 g) and the content ranged from 4.45% to 61.82% for amoxilcillin and 15.75% to 30.25% for sulbactam.The root mean square errors of cross validation (RMSECV), determination coefficients (R 2) and root mean square errors of prediction (RMSEP) respectively was 0.858 , 0.998 1 and 0.936 for amoxilcillin, and respectively was 0.541 , 0.988 1 and 0.423 for sulbactam.The model was tested based on 5 batches of commercial samples and 5 batches of laboratory samples (0.75 g) and the results well met with those of the legal methods with difference ≤ 1.5 %.The model also applied in 10 batches of commercial samples (1.5 g) and 2 batches of samples from the other manufacturers.Conclusion: The non-destructive quantitative NIR methods are accurate with good reproducibility, and applicable for the rapid analysis of amoxilcillin sodium and sulbactam sodium for injection.
ABSTRACT
Objective:To establish a method for the content determination of pantoprazole sodium for injection by high performance capillary electrophoresis. Methods:The determination was performed on an uncoated elastic quartz capillary column, the running buff-er was 0. 01 mol·L-1 potassium dihydrogen phosphate buffer, the running voltage was 25kV,the column temperature was 25℃ and the detection wavelength was 289 nm. Results:The linear range was good within the concentration range of 20. 05-200. 51 μg·ml-1(r=0. 999 6). The average recovery was 99. 03%(RSD=0. 86%, n=9). Conclusion:The method is simple, sensitive and reproduci-ble, and can be used in the determination of pantoprazole sodium for injection.