HPLCELSD determination Isepamicin sulfate injection levels.docVIP

 PAGE \* MERGEFORMAT 8 HPLCELSD determination Isepamicin sulfate injection levels [Abstract] Objective To establish a high-performance liquid chromatography  evaporative light scattering detection (HPLC  ELSD) Determination of Isepamicin sulfate for injection HPLC method. Methods The analytical column was Zorbax SB  C18 column (250 mm * 4.6 mm, 5 μ m), mobile phase of 1% trifluoroacetic acid aqueous solution  methanol (volume ratio 95:5)), flow rate: 0.5 mL / min; evaporative light - scattering detector, drift tube temperature of 45 ℃ , carrier gas pressure of 368 Pa. Results Isepamicin in the 0.1 ~ 0.8 mg / mL was within the framework of a good linear relationship (r = 0.9995), average recovery was 101.0%, RSD = 0.32%; system precision RSD = 0.34%. Conclusion The method is simple, rapid, method precision, accuracy and reproducibility were better meet the requirements of quality control can be used for Isepamicin sulfate for injection of quality control. [Keywords:] high-performance liquid chromatography; evaporative light scattering detector; sulfate Isepamicin Abstract: Objective To establish an HPLC  ELSD method for the quantification of isepamicin sulfate in the injection. Methods The analysis was performed on a column of Zorbax SB C18 (250 mm * 4.6 mm, 5 μ m). The mobile phase consisted of 1% tifluoroacetic  methanol (95:5) and the flow rate was 0. 5 mL * min-1. The drift tube temperature was 45 ℃ , ELSD was used as the detector with pressure of nebulizing gas of 368 Pa. Results The calibration curve was linear in the range of 0.1 ~ 0.7 mg / mL (r = 0. 9995). The average recovery was 101. 0% with RSD 0.32%. Conclusion This method is simple, rapid, accurate and reproducible for the quality control of the injection of isepamicin sulfate. Keywords:: HPLC; evaporative light-scattering detection; isepamicin sulfate Isepamicin sulfate as the aminoglycoside antibiotics, gentamicin B by a semi-synthetic from, currently only in Japan, the benchmar