Establishment of NIR Quantitative Model for the Determination of Amoxilcillin Sodium and Sulbactam Sodium for Injection
- VernacularTitle:注射用阿莫西林钠/舒巴坦钠近红外快速定量分析模型的建立
- Author:
Lei ZHANG
;
Dazhong DING
;
Weijie YU
;
Li LI
;
Chengzhang LUAN
;
Liang WANG
- Keywords:
Near infrared diffuse reflectance spectroscopy;
Amoxilcillin sodium and sulbactam sodium for injection;
Quantitative model
- From:
China Pharmacist
2017;20(8):1496-1498
- CountryChina
- Language:Chinese
-
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.
