中医临床研究
中醫臨床研究
중의림상연구
CLINICAL JOURNAL OF CHINESE MEDICINE
2014年
17期
137-140
,共4页
高效液相色谱法%注射用兰索拉唑%含量测定
高效液相色譜法%註射用蘭索拉唑%含量測定
고효액상색보법%주사용란색랍서%함량측정
HPLC%Lansoprazole for injection%Determination
目的：研究注射用兰索拉唑制剂工艺，并采用高效液相色谱法建立其含量测定方法。方法：制备注射用兰索拉唑， AlltimaTM C18柱（4.6mm×250mm，5μm）；乙腈-水-三乙胺（40∶60∶1）（用磷酸调节pH值至7.0）为流动相；检测波长为285 nm。结果：制剂中辅料对主药测定无干扰，兰索拉唑在32.16～75.04μg/mL浓度范围内，峰面积与浓度呈良好的线性关系；精密度（RSD＝0.20%）良好；平均回收率为99.4%，RSD＝0.94%（n＝9）。结论：本方法简便、迅速、准确、专属性强，可用于注射用兰索拉唑的含量测定。
目的：研究註射用蘭索拉唑製劑工藝，併採用高效液相色譜法建立其含量測定方法。方法：製備註射用蘭索拉唑， AlltimaTM C18柱（4.6mm×250mm，5μm）；乙腈-水-三乙胺（40∶60∶1）（用燐痠調節pH值至7.0）為流動相；檢測波長為285 nm。結果：製劑中輔料對主藥測定無榦擾，蘭索拉唑在32.16～75.04μg/mL濃度範圍內，峰麵積與濃度呈良好的線性關繫；精密度（RSD＝0.20%）良好；平均迴收率為99.4%，RSD＝0.94%（n＝9）。結論：本方法簡便、迅速、準確、專屬性彊，可用于註射用蘭索拉唑的含量測定。
목적：연구주사용란색랍서제제공예，병채용고효액상색보법건립기함량측정방법。방법：제비주사용란색랍서， AlltimaTM C18주（4.6mm×250mm，5μm）；을정-수-삼을알（40∶60∶1）（용린산조절pH치지7.0）위류동상；검측파장위285 nm。결과：제제중보료대주약측정무간우，란색랍서재32.16～75.04μg/mL농도범위내，봉면적여농도정량호적선성관계；정밀도（RSD＝0.20%）량호；평균회수솔위99.4%，RSD＝0.94%（n＝9）。결론：본방법간편、신속、준학、전속성강，가용우주사용란색랍서적함량측정。
Objective:To prepare lansoprazole for injection and establish a HPLC method for determing the content of lansoprazole in lansoprazole for injection. Methods: A AlltimaTM C18 column (4.6mm×250mm, 5μm) was used. The mobile phase was acetonitrile-water-triethylamine (40:60:1, adjusted to pH=7.0 with phosphoric acid). The determination wavelength was 285nm. Results:The excipients did not interfere with the determination of lansoprazole. The linear range of lansoprazole was 32.16~75.04μg·m-1. The precision of the method (RSD=0.20%) was good. The average recovery was 99.4%, and RSD was 0.94%(n=9). Conclusion:The method is simple, speedy, accurate and specific for the quantitation of lansoprazole.
