埃索美拉唑镁usp34标准.doc

２０１０　ＵＳＰＣ　Ｏｆｆｉｃｉａｌ　５／１／１１　－　７／３１／１１　ＵＳＰ　Ｍｏｎｏｇｒａｐｈｓ：　Ｅｓｏｍｅｐｒａｚｏｌｅ　．．． 页码，１／７ Esomeprazole Magnesium es oh mep ra zole mag nee zee um. C34H36 MgN6O6 S2·3H2 O Trihydrate: 767.17 C34H36 MgN6O6 S2 Anhydrous: 713.12 1H-Benzimidazole5-methoxy-2-S-4-methoxy-35-dimethyl-2-pyridinylmethylsulfinyl magnesium salt 2:1 trihydrate 5-Methoxy-2- S-4-methoxy-35-dimethyl-2-pyridylmethylsulfinylbenzimidazole magnesium salt 2:1 trihydrate 217087 -09-7. DEFINITION Esomeprazole Magnesium contains NLT 98.0 and NMT 102.0 of C34 H36 MgN6O 6S2 calculated on the anhydrous basis. IDENTIFICATION A. INFRARED ABSORPTION 197K B. The Sample solution prepared and tested as directed in the test for Content of Magnesium exhibits a significant absorption at 285.2 nm. ASSAY PROCEDURE Solution A: Dissolve 0.725 g of monobasic sodium phosphate and 4.472 g of anhydrous dibasic sodium phosphate in 300 mL of water and dilute with water to 1000 mL. Dilute 250 mL of this solution with water to 1000 mL. If necessary adjust with phosphoric acid to a pH of 7.6. Solution B: Mix 11 mL of 0.25 M tribasic sodium phosphate with 22 mL of 0.5 M dibasic sodium phosphate and dilute with water to 100 mL. Mobile phase: Acetonitrile and Solution A 7:13 Standard solution: Transfer 10 mg of USP Omeprazole RS to a 200-mL volumetric flask and dissolve in about 10 mL of methanol. Add 10 mL of Solution B and dilute with water to volume. NOTE—This solution contains 0.05 mg/mL of omeprazole. Sample solution: Transfer 10 mg of Esomeprazole Magnesium to a 200-mL volumetric flask and dissolve in about 10 mL of methanol. Add 10 mL of Solution Bｆｉｌｅ：／／Ｃ：＼ｃｏｍ＿ｃａｉｓｌａｂｓ＿ｅｂｋ＼ｄａｔａ＼ｖ３４２９０＼ｕｓｐ３４ｎｆ２９ｓ０＿ｍ３０５８８．ｈｔｍｌ ２０１１－５－４ ２０１０　ＵＳＰＣ　Ｏｆｆｉｃｉａｌ　５／１／１１　－　７／３１／１１　ＵＳＰ　Ｍｏｎｏｇｒａｐｈｓ：　Ｅｓｏｍｅｐｒａｚｏｌｅ　．．． 页码，２／７ and dilute with water to volume. NOTE—This solution contains 0.05 mg/mL of esomeprazole magnesium. Chromatographic system See Chromatography 621 System Suitability. Mode: LC Detector: UV 280 nm Column: 4.0-mm × 12.5-cm or a 4.6-mm × 15-cm 5-m packi