A new technology based on transmission Raman spectroscopy was developed for the determination of diclofenac sodium (DS) in commercially available tablets using chemometric tools such as partial least squares (PLS). Based on multifactor orthogonal design of experiment (DOE), we established an initial model consisting of 150 handmade tablets. By adding only two commercially available tablets spectra to the initial model, it was successfully applied to the determination of the active pharmaceutical ingredient (API) of three commercially available diclofenac sodium tablets. The results showed that the relative error of content measured by TRS for three brands of tablets was less than 4% and the RSD of 20 commercially available tablets under brand of Ouyi was 0.49%. The method can ensure high accuracy and good repeatability in rapid nondestructive quantitative analysis and can be used as a new technology for quality control on production lines to monitor drugs in real time.calibration model update, chemometrics, commercially available tablet, diclofenac sodium, transmission Raman spectroscopy
| INTRODUCTIONDiclofenac sodium (DS) is a nonsteroidal anti-inflammatory drug (NSAID) that is used for antipyretic, analgesic, and anti-inflammatory purposes. 1 At present, there are two forms of potassium salt and sodium salt on the market. Compared with potassium salt, diclofenac sodium acts at a slower pace. 2 Diclofenac sodium is available in a variety of forms, such as tablets, capsules, sprays, creams, and so on. 3 In the production process, the control of drug content is very important to avoid counterfeit and inferior drugs and ensure the safety and effectiveness of drugs. At present, the determination of diclofenac sodium content mostly adopts high-performance liquid chromatography (HPLC), 4-6 thin-layer chromatography, 7 infrared spectroscopy, 8-10 flowinjection spectrophotometric, 11 gas chromatography, 12-14 capillary electrophoresis, 15,16 and traditional Raman spectroscopy. 17-19 Among them, Raman spectroscopy is one of the commonly used methods for determination of drug content. In recent years, Raman spectroscopy has also been widely used for the identification of the counterfeit Xuejia Zhao and Ning Wang contributed equally to this work.