DRIFTS Method Applied to Quantification of Cephalexin in Powder for Oral Suspension - A Process Analytical Technology (PAT) Approach

Conventional methods are labor intensive, time spending and do not allow real time analysis. Infrared spectroscopic is an alternative to conventional methods, with several advantages including its application in process analytical technology (PAT). The aim of the paper was to develop a diffuse reflectance infrared spectroscopic (DRIFTS) method for cephalexin analysis in powder for suspension. Calibration and validation samples were prepared by mixing cephalexin with a placebo preparation in several levels, containing from 80 to 130% of labeled content of commercial products. Method validation was assess by precision (repeatability RSD = 2.2 %, and intermediate precision RSD = 3.0%) and accuracy (mean recovery = 98.3%). In addition, commercial samples were analyzed using DRIFTS, HPLC, and bioassay. According to the results of equivalence test, DRIFTS provides similar results to those obtained using HPLC and Bioassay. Therefore, the DRIFTS may be employed in PAT by pharmaceutical industry.