Quality Analysis of Loxoprofen Sodium Tablets

OBJECTIVE To evaluate the current quality situation and problems of loxoprofen sodium tablets by testing and analyzing 41 batches of loxoprofen sodium tablets collected from the realm of drug production and circulation all over the Zhejiang provience in 2017. METHODS The prescribed examination was combined with exploratory research as the current standard could not completely control the product quality. X-ray diffraction method was used to determine the crystal form. HPLC was used to determine the chiral separation, related substances, dissolution and stability. ICP-OES was used to determine the residue of bromine. Near infrared spectrum database was established by near infrared spectroscopy. The results of the prescribed examination and exploratory research were statistically analyzed. RESULTS There were differences between the results of the prescribed examination and exploratory research. CONCLUSION The results of exploratory research show that there are defects in some statutory standards. The product quality of different manufacturers is variant, and it is necessary to guide them to improve the preparation process and the quality. More perfect methods shall be used to completely control the quality.