Content Determination of Ketorolac Tromethamine Biphasic Controlled Release Tablet by HPLC Method
Objective To use high performance liquid chromatography(HPLC)method for the determination of the content of ketorolac tromethamine(KT)in KT biphasic controlled release tablet.Methods The HPLC column was DIKMA C18(250 mm× 4.6 mm,5 μm);mobile phase:methanol-water-glacial acetic acid(65∶34∶1);detection wave-length:318 nm;liquid-phase flow rate:0.90ml/min;column temperature:40 ℃;injection volume:20 μl.Results The concentration of KT at 5-400 μg/ml showed good linearity(R2=0.9998);the average recovery of immediate-release lay-er was 102.27％,the relative standard deviation(RSD)was 0.93％,the average recovery of controlled-release layer was 100.37％,and RSD was 0.18％;the content homogeneity of KT biphasic controlled release tablet in the immediate-release layer and in the controlled-release layer were in compliance with the pharmacopoeia regulations.Conclusion The specificity of the method for the determination of KT biphasic controlled release tablet established in this study is strong,the reproducibility is good and the results are accurate,which can be used for the quality control to the biphasic controlled release tablet.
Ketorolac tromethamineBiphasic controlled release tabletHigh performance liquid chromatographyQuality control
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