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看不懂的系統(tǒng)適用性案例-EP8.0 頭孢他啶 已有2人參與
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EP8.0 頭孢他啶原料藥質(zhì)量標準中雜質(zhì)F（即吡啶）的含量測定方法如下： Impurity F. Liquid chromatography (2.2.29). Prepare the solutions immediately before use. Phosphate buffer solution. Prepare a 10 per cent V/V solution of phosphate buffer solution pH 7.0 R4. Test solution. Dissolve 0.500 g of the substance to be examined in phosphate buffer solution and dilute to 100.0 mL with the same solution.（供試品濃度為5mg/ml） Reference solution (a). Dissolve 1.00 g of pyridine R in water R and dilute to 100.0 mL with the same solvent. Dilute 5.0 mL of the solution to 200.0 mL with water R. Dilute 1.0 mL of this solution to 100.0 mL with phosphate buffer solution.（對照品濃度為2.5ug/ml，限度為500ppm） Reference solution (b). Dilute 1 mL of the test solution to 200 mL with phosphate buffer solution. To 1 mL of this solution add 20 mL of reference solution (a) and dilute to 200 mL with phosphate buffer solution.（原料藥濃度為0.125ug/ml（相當于供試品濃度的0.0025%），吡啶濃度為0.25ug/ml（相當于限度濃度的10%）。為什么溶液B中原料藥的濃度不是供試品一樣，即供試品為5mg/ml，吡啶為2.5ug/ml？這樣設(shè)計是出于什么考慮？） Column: – size: l = 0.25 m, Ø = 4.6 mm; – stationary phase: octadecylsilyl silica gel for chromatography R (5 μm). Mobile phase: mix 8 volumes of a 28.8 g/L solution of ammonium dihydrogen phosphate R previously adjusted to pH 7.0 with ammonia R, 24 volumes of acetonitrile R and 68 volumes of water R. Flow rate: 1.0 mL/min. Detection: spectrophotometer at 255 nm. Injection: 20 μL. Run time: 10 min. System suitability: reference solution (b): – resolution: minimum 7.0 between the peaks due to ceftazidime and impurity F. Limit: – impurity F: not more than the area of the principal peak in the chromatogram obtained with reference solution (a) (500 ppm). |
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