Rapid Determination of Cefmenoxime and Moisture in Cefmenoxime Hydrochloride for Injection by Near-infrared Spectroscopy

OBJECTIVE To develop a universal near-infrared reflectance model for rapid and nondestructive determination of cefmenoxime and moisture in cefmenoxime hydrochloride for injection. METHODS Using cluster analysis method, cefmenoxime hydrochloride for injection from different pharmaceutical companies were measured by a fiber optic probe and were divided into calibration and validation groups. Then, the quantitative models were established using partial least square through selection of different wavelength ranges, preprocessing methods. RESULTS For the quantitative model of cefmenoxime content, 36 batches of samples were used as calibration set, and 17 batches as validation set. The root mean square error of calibration was 1.19%, and the root mean square error of validation was 1.66%, and correlation coefficients was 96.33%. For the quantitative model of water content, 34 batches of samples were used as calibration set, and 19 batches as validation set. The root mean square error of calibration was 0.22%, and the root mean square error of validation was 0.26%, and correlation coefficients was 96.39%. CONCLUTION Using this two quantitative models, cefmenoxime hydrochloride for injection can be quickly evaluated. The method is simple and rapid, and can be used in the mobile lab.