黑龙江医药
黑龍江醫藥
흑룡강의약
HEILONGJIANG MEDICAL JOURNAL
2014年
4期
742-743,744
,共3页
苯唑西林%苯唑西林钠片聚合物%凝胶色谱法
苯唑西林%苯唑西林鈉片聚閤物%凝膠色譜法
분서서림%분서서림납편취합물%응효색보법
oxacillin%oxacillin sodium tables%size exclusion chromatagraphy
目的：建立凝胶色谱法（SEC）测定苯唑西林钠片聚合物。方法：采用依利特色谱柱（填料：Sephadex G-10；尺寸：10.0mm×300mm）；流动相A为pH7.0的0.01mol·mL-1磷酸盐缓冲液[0.01mol·mL-1磷酸氢二钠溶液-0.01mol·mL-1磷酸二氢钠溶液（61：39）]，流动相B为超纯水；流速1.0mL·min-1；检测波长为254nm；进样量为200μL；以苯唑西林对照品进行测定，按外标法定量。结果：苯唑西林的线性范围1.8051μg·mL-1～18.0511μg·mL-1（r=1.0000），定量限为1×10-3mg·mL-1，重复性良好（RSD为0.24%，n=6）；供试品测定的线性范围为1.1252mg·mL-1～11.4653 mg·mL-1（r=0.9997），重复性良好（RSD为2.17%， n=5）。结论：该方法能够较好地分离苯唑西林钠和聚合物，可用于苯唑西林钠片聚合物的检验。
目的：建立凝膠色譜法（SEC）測定苯唑西林鈉片聚閤物。方法：採用依利特色譜柱（填料：Sephadex G-10；呎吋：10.0mm×300mm）；流動相A為pH7.0的0.01mol·mL-1燐痠鹽緩遲液[0.01mol·mL-1燐痠氫二鈉溶液-0.01mol·mL-1燐痠二氫鈉溶液（61：39）]，流動相B為超純水；流速1.0mL·min-1；檢測波長為254nm；進樣量為200μL；以苯唑西林對照品進行測定，按外標法定量。結果：苯唑西林的線性範圍1.8051μg·mL-1～18.0511μg·mL-1（r=1.0000），定量限為1×10-3mg·mL-1，重複性良好（RSD為0.24%，n=6）；供試品測定的線性範圍為1.1252mg·mL-1～11.4653 mg·mL-1（r=0.9997），重複性良好（RSD為2.17%， n=5）。結論：該方法能夠較好地分離苯唑西林鈉和聚閤物，可用于苯唑西林鈉片聚閤物的檢驗。
목적：건립응효색보법（SEC）측정분서서림납편취합물。방법：채용의리특색보주（전료：Sephadex G-10；척촌：10.0mm×300mm）；류동상A위pH7.0적0.01mol·mL-1린산염완충액[0.01mol·mL-1린산경이납용액-0.01mol·mL-1린산이경납용액（61：39）]，류동상B위초순수；류속1.0mL·min-1；검측파장위254nm；진양량위200μL；이분서서림대조품진행측정，안외표법정량。결과：분서서림적선성범위1.8051μg·mL-1～18.0511μg·mL-1（r=1.0000），정량한위1×10-3mg·mL-1，중복성량호（RSD위0.24%，n=6）；공시품측정적선성범위위1.1252mg·mL-1～11.4653 mg·mL-1（r=0.9997），중복성량호（RSD위2.17%， n=5）。결론：해방법능구교호지분리분서서림납화취합물，가용우분서서림납편취합물적검험。
Objective:To establish a size exclusion chromatography (SEC) method for the determination of the polymers in oxacili-in sodium tables. Methods:A Sephadex G-10 gelcolumn (10.0mm×300mm) was used.The mobile phase A was 0.01mol·mL-1 phos-phate buffer solution (pH=7.0), and B was water.The flow rate was 1.0mL·min-1, the detection wavelength was at 254nm, the injection volume was 200μL and the concentration of polymers was quantified by external standard method. Oxacllin was used as substitute ref-erence substance. Results:For HPSEC method, the calibration curves were linera in the range of 1.8051μg·mL-1-18.0511μg·mL-1for oxillin(r=1.0000), and the limit of quantitation was 1×10-3mg·mL-1,The RSD for replicate injection of reference solution was 0.24%(n=5), and the calibratin curves were linear in the range of 1.1252mg·mL-1~11.4653 mg·mL-1 for oxacillin (r=0.9997), and the repeat-ability for 5 measurement results was 2.17%(n=5). Conclusition:This method can be used in separating the polymers from oxacillin preferably, and is suitable for controlling the quality of this drug.
