Determination of Contents and Related Substances in Loxoprofen Sodium Tablets by RP-HPLC / 中国药房

ABSTRACT

OBJECTIVE:To improve the determination method for the contents of main components and related substances in Loxoprofen sodium tablets. METHODS:RP-HPLC method was adopted. The determination was performed on Inspire C18 column with mobile phase consisted of acetonitile-0.01 mol/L potassium dihydrogen phosphate(containing 0.2% triethylamine,phosphoric acid adjusted to 3.0±0.1,62 38,V/V)at the flow rate of 1.0 mL/min. The column temperature was 40 ℃,and the detection wave-length was set at 221 nm. The sample size was 20 μL. RESULTS:The peak of loxoprofen sodium was well separated with the peak of its related substances(R>1.5). The linear range of loxoprofen sodium ranged 30.0-90.0 μg/mL(r=0.9998). The detection lim-it of loxoprofen was 0.3 μ g/mL. RSDs of precision,stability and repeatability tests were <1.0% . The average recovery rates ranged 99.00%-99.87%(RSD=0.33%,n=9). CONCLUSIONS:This method is accurate,simple,rapid and suitable for the quali-ty control of Loxoprofen sodium tablets.