上海医药
上海醫藥
상해의약
SHANGHAI MEDICAL & PHARMACEUTICAL JOURNAL
2015年
1期
75-77
,共3页
HPLC法%马来酸氯苯那敏注射液%有关物质
HPLC法%馬來痠氯苯那敏註射液%有關物質
HPLC법%마래산록분나민주사액%유관물질
HPLC%chlorphenamine maleate injection%related substances
目的：建立HPLC法测定马来酸氯苯那敏注射液有关物质的方法。方法：采用高效液相色谱法，色谱柱为C18柱(4.6 mm ×250 mm，5μm)；流动相为乙腈-0.857%磷酸二氢铵溶液（20∶80）（用磷酸调节pH值至3.0）；流速：1.2 ml/min；检测波长：225 nm。结果：氯苯那敏峰与杂质A、B、C、D峰之间的分离度良好，氯苯那敏及四个杂质的最小检测限分别为0.017、0.016、0.077、0.030、0.053μg/ml。结论：该法简便、准确、专属性好、灵敏度高，可作为马来酸氯苯那敏注射液有关物质的检查方法。
目的：建立HPLC法測定馬來痠氯苯那敏註射液有關物質的方法。方法：採用高效液相色譜法，色譜柱為C18柱(4.6 mm ×250 mm，5μm)；流動相為乙腈-0.857%燐痠二氫銨溶液（20∶80）（用燐痠調節pH值至3.0）；流速：1.2 ml/min；檢測波長：225 nm。結果：氯苯那敏峰與雜質A、B、C、D峰之間的分離度良好，氯苯那敏及四箇雜質的最小檢測限分彆為0.017、0.016、0.077、0.030、0.053μg/ml。結論：該法簡便、準確、專屬性好、靈敏度高，可作為馬來痠氯苯那敏註射液有關物質的檢查方法。
목적：건립HPLC법측정마래산록분나민주사액유관물질적방법。방법：채용고효액상색보법，색보주위C18주(4.6 mm ×250 mm，5μm)；류동상위을정-0.857%린산이경안용액（20∶80）（용린산조절pH치지3.0）；류속：1.2 ml/min；검측파장：225 nm。결과：록분나민봉여잡질A、B、C、D봉지간적분리도량호，록분나민급사개잡질적최소검측한분별위0.017、0.016、0.077、0.030、0.053μg/ml。결론：해법간편、준학、전속성호、령민도고，가작위마래산록분나민주사액유관물질적검사방법。
Objective:To establish an HPLC method for the determination of related substances in chlorphenamine maleate injection.Methods:The HPLC was carried out on a C18 column (4.6 mm×250 mm, 5μm) with a mobile phase of acetonitrile - 0.857% of ammonium dihydrogen phosphate solution (20:80) (adjusted to pH 3.0 with phosphoric acid) at the lfow rate of 1.2 ml/min and the detected UV wavelength of 225 nm.Results: Good separation among the peaks of chlorphenamine and impurity A, B, C, D was obtained. The detection limits of chlorphenamine and 4 impurities were 0.017, 0.016, 0.077, 0.030 and 0.053μg/ml, respectively.Conclusion:This method is simple, accurate with good speciifcity and high sensitivity and can be used for the analysis of related substances in chlorphenamine maleate injection.
