pantoprazole-sodium-中國(guó)藥典標(biāo)準(zhǔn)翻譯-資料下載頁(yè)
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【正文】 o, starts from “add 2ml of hydrochloric acid”. The heavy metals should not be more than 20ppm.[Content Determination] Carry out the method for high performance liquid chromatography (Appendix Ⅴ D). Chromatographic conditions and system suitability The column is packed with octadecyl silane bonded silica gel。 The mobile phase is mol/L dipotassium hydrogen phosphate solution (adjust pH to by phosphoric acid) acetonitrile (65:35). The detection wavelength is 288 nm. The number of the theoretical plate calculated from pantoprazole peak is not less than 2500. Procedure Dissolve a quantity of the product being examined, weigh accurately, in a mixture of mol/L sodium hydroxideacetonitrile (1:1) to obtain a solution of about 40 μg per ml. Inject 20 μl and record the chromatogram. Repeat the operation using Pantoprazole Sodium standard instead of the product being examined. Calculate the content of C16H14F2N3NaO4S with respect to the peak area obtained in the chromatogram by the external standard method. [Category] Digestive system medicine.[Storage] Preserve in tightly closed containers, stored in a cool place and dark place.[Preparation] Pantoprazole Sodium for Injection內(nèi)容總結(jié)
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