HPLC Determination of Pefloxacin Mesylate Tablets and related substances.docVIP

 PAGE \* MERGEFORMAT 12 HPLC Determination of Pefloxacin Mesylate Tablets and related substances Authors: Li Xulun, Li Xia, Zeng Jie, Liu Ying Qian [Abstract] Objective: To establish a high-performance liquid chromatographic determination of pefloxacin mesylate tablets drugs and related substances. Methods: The analytical column was C18 column (150 mm * 6 mm, 5 μ m), mobile phase of acetonitrile  2.70 g / L cetyltrimethyl ammonium bromide and 6.18 g / L boric acid solution of the mixed solution (with 1 mol / L sodium hydroxide solution, pH adjusted accurately to 8.30)  Thiodiglycol (30:70:0.2) and the detection wavelength of 273 nm. Results: pefloxacin mesylate in the 17.18 ~ 85.90 μ g / mL and the peak area was within the framework of a good linear relationship (r = 0.999 9), the average recovery was 99.50%, 99.71%, 99.62%, the lowest detection limit and quantitative limits were 0.01989 ng and 0.08517 ng, and impurity, and quinolone congeners can be effectively separated. Conclusion: The method is simple, accurate, specific and can be used for pefloxacin mesylate tablets drug content and its related substances testing. [Keywords:] Pefloxacin Mesylate; high-performance liquid chromatography; related substances [Abstract] Objective: To establish a method for the assay of pefloxacin mesilate tablets and its related substance by HPLC. Methods: The analysis was conducted by HPLC using a C18 (150 mm * 6 mm, 5 μ m) column. The mobile phase was acetonitrile  mixture of 2.70 g / L cetyltrimethylammonium bromide with 6.18 g / L boric acid solution (adjusted to pH 8.30 with 1 mol / L sodium hydroxide)  2,2 ‘ thiodiglycol (30:70:0.2). The detection wavelength was set at 273 nm. Results: The precision and stability were fine. The linear correlation of pefloxacin mesilate tablets was observed within the range of 17.18 ~ 85.90 μ g / mL (r = 0.9999). The average recoveries were 99.50%, 99.71% and 99.62 %. The limit of detection and quantification was 0.01989 n