Applications of FT-Raman Spectroscopy in the Quality Assurance/Quality Control (QA/QC) of Drugs

Abstract

FT-Raman spectroscopic technique was applied to identify and quantify the active pharmaceutical ingredient (API) in the raw material and commercial forms of a drug model. As it is a common anti- inflammatory drug and usually used as a drug model in the area of drug research, diclofenac-sodium was used as a drug model in this work. Series of different concentrations ranging from 10% to 100% (with an increment of 10%) of pure diclofenac-Na were prepared in a matrix of pure starch. Heights and areas of some characteristic peaks in the FT-Raman spectra of the diclofenac-Na samples were calculated for each concentration to obtain calibration curves. These curves were used to predict the concentration of the diclofenac-Na in some prepared samples and some commercial formulae. The accuracy of these calibration curves was found to be in the range 98.3-99.8% and was comparable to that obtained by the HPLC technique, the standard official method used in QA/QC of drugs. The predictive ability of the calibration models based on the peaks' heights and areas were also tested by calculation of the relative standard error of prediction (RSEP). The RSEP values were 2.2%-4.1% and 2.9%-3.4% for peaks' heights and areas models, respectively. In conclusion, the results of this work suggest the FT-Raman spectroscopy as a new accurate, relatively quick and economic method, in comparison with the HPLC method, in QA/QC in the field of drug industry.