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EP8.0 Í·æßËûà¤Ô­ÁÏÒ©ÖÊÁ¿±ê×¼ÖÐÔÓÖÊF£¨¼´ßÁण©µÄº¬Á¿²â¶¨·½·¨ÈçÏ£º
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.£¨¹©ÊÔÆ·Å¨¶ÈΪ5mg/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.£¨¶ÔÕÕÆ·Å¨¶ÈΪ2.5ug/ml£¬ÏÞ¶ÈΪ500ppm£©
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.£¨Ô­ÁÏҩŨ¶ÈΪ0.125ug/ml£¨Ï൱ÓÚ¹©ÊÔÆ·Å¨¶ÈµÄ0.0025%£©£¬ßÁà¤Å¨¶ÈΪ0.25ug/ml£¨Ï൱ÓÚÏÞ¶ÈŨ¶ÈµÄ10%£©¡£ÎªÊ²Ã´ÈÜÒºBÖÐÔ­ÁÏÒ©µÄŨ¶È²»Êǹ©ÊÔÆ·Ò»Ñù£¬¼´¹©ÊÔÆ·Îª5mg/ml£¬ßÁà¤Îª2.5ug/ml£¿ÕâÑùÉè¼ÆÊdzöÓÚʲô¿¼ÂÇ£¿£©
Column:
¨C size: l = 0.25 m, Ø = 4.6 mm;
¨C stationary phase: octadecylsilyl silica gel for
chromatography R (5 ¦Ìm).
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 ¦ÌL.
Run time: 10 min.
System suitability: reference solution (b):
¨C resolution: minimum 7.0 between the peaks due to
ceftazidime and impurity F.
Limit:
¨C 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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