High-performance liquid chromatography Clofarabine Clofarabine Injection content.docVIP

 PAGE \* MERGEFORMAT 8 High-performance liquid chromatography Clofarabine Clofarabine Injection content Author: Wang Juan, Zhang Rong, ZHAO Yan-yan, Lu Lai-Chun [Abstract] Objective: To establish a high-performance liquid chromatography Clofarabine injection drug clofarabine main content. Methods: Shim  pack VP  ODS (5 μ m, 4.6 mm * 150 mm) column, mobile phase of acetonitrile  ammonium acetate solution (ammonium acetate obtained 0.31 g, dissolved in water and diluted to 1 000 mL, together with formic acid 1.0 mL) (10:90), flow rate 1.0 mL / min, injection volume 20 μ L, detection wavelength 262 nm. Results: Clofarabine in the sample volume 0.4 ~ 242.5 μ g / mL range a good linear relationship, the regression equation is A = 23156C 12378 (r = 0.9999, n = 5), the average recovery was 99.97%, RSD 0.40 %. Conclusion: This method is rapid, simple, accurate and can be used to control the quality of preparation. [Keywords:] high-performance liquid chromatography; Clofarabine; Determination [Abstract] Objective: To establish a high performance liquid chromatograph (HPLC) method to assay the concentration of clofarabine in clofarabine injection. Methods: Shim  pack VP  ODS (5 μ m, 4.6 mm * 150 mm) column and a mobile phase of acetonitrile  ammonium acetate solution (water containing 4 mmol / L ammonium acetate and 0.1% of formic acid) (10:90) were used with the flow rate of 1.0 mL / min. The detection wave length was 262 nm. Results: There was a linear relationship within the range of 0.4 ~ 242.5 μ g / mL and the regression equation was A = 23156C 12378 (r = 0.9999, n = 5). The average relative recovery rate was 99.97% and RSD was 0.40%. Conclusions: This method is simple, accurate and able to control the quality of the preparation. [Keywords:] High performance liquid chromatograph; Clofarabine; Determination Clofarabine Genzyme Corporation by the U.S. research and development, adopted by the U.S. FDA fast-track procedure was January 11, 2005 list