HPLC Determination of valrubicin bladder drip liquid content and related substances.docVIP

 PAGE \* MERGEFORMAT 20 HPLC Determination of valrubicin bladder drip liquid content and related substances [Abstract] Objective To establish a suitable high-performance liquid chromatography valrubicin Liquid valrubicin bladder drip content and related substances. Methods Shimadzu Shim-pack VP-ODS column; mobile phase of 0.015mol / L phosphate solution (extracted from phosphoric acid 1ml, diluted with water to 1000ml): acetonitrile (43:57); column temperature 35 ℃ ; detection wavelength 254nm; flow rate 1.5ml/min. The results of main ingredients or degradation products and impurities, and a good separation, empty oil accessories without interference. In order to test samples of this Act contained 0.05% ~ 10% range of related substances, the linear relationship was good; in 0.01 ~ 1.18mg/ml concentration within valrubicin peak area showed good linear relationship is suitable for determination. Related substances detected LOD of 0.1μ g/ml, equivalent to the concentration could be detected as low as 0.01% of all impurities and or degradation products. Related substances test results good repeatability; assay repeatability valrubicin measured by the average content of 96.8% (RSD = 0.34%, n = 9). Valrubicin Determination of the average recovery was 100.5% (RSD = 0.4%, n = 9). Conclusion This method is superior to USP chromatographic method of a theory, specific and more applicable to a fluid drip valrubicin bladder and its related substances by HPLC detection. [Keywords:] Valrubicin; bladder infusion fluid; high-performance liquid chromatography; determination; related substances ABSTRACT Objective To establish an alternative high performance liquid chromatography method for the determination of valrubicin and its related substances in valrubicin intravesical solution. Methods TheHPLC method was applied with a Shimadzu Shim-pack VP-ODS (4.6mm * 150mm, 5μ m) column by anelution system consisted of 0.015 mol / L phosphate acid solution (phosphate acid 1ml added to