Abstract:

To develop near-infrared (NIR) reflectance spectroscopic methods for the quantitative analysis of cefoperazone sodium/sulbactam sodium from different manufacturers for injection powder medicaments. Various powders of cefoperazone sodium/sulbactam sodium were directly analyzed by non-destructive NIR reflectance spectroscopy using the spectrometer EQUINOX55. Two quantitative methods via integrating sphere (IS) and fiberoptic probe (FOP) models were explored from 6 batches of commercial samples and 42 batches of laboratory samples at a content ranging from 30% to 70% for cefoperazone and 60% to 20% for sulbactam. The root mean square errors of cross validation (RMSECV) and the root mean square errors of prediction (RMSEP) of IS were 1.79% and 2.85%, respectively, for cefoperazone sodium, and were 1.86% and 3.08%, respectively, for sulbactam sodium; and those of FOP were 2.93% and 2.92%, respectively, for cefoperazone sodium, and were 2.23% and 3.01%, respectively, for sulbactam sodium. Based on the ICH guidelines and Ref. 12, the quantitative models were then evaluated in terms of specificity, linearity, accuracy, precision, robustness and model transferability. The non-destructive quantitative NIR methods used in this study are applicable for rapid analysis of injectable powdered drugs from different manufacturers.

Key words: NIR diffuse reflectance spectroscopy, NIR diffuse reflectance spectroscopy, Non-destructive determination, Non-destructive determination, Cefoperazone sodium/sulbactam sodium, Cefoperazone sodium/sulbactam sodium, Injection powder medicament, Injection powder medicament, Validation, Validation, Counterfeit medicine, Counterfeit medicine