CAJ | 학술논문

目的：建立RP-HPLC测定高三尖杉酯碱及其制剂有关物质的方法，并用其分析不同处理后高三尖杉酯碱有关物质的量。方法采用Germsil-P C18色谱柱（250×4.6 mm，5μm），以10 mmol·L-1磷酸二氢钾溶液为流动相A，甲醇为流动相B，梯度洗脱，流速1 mL·min-1，检测波长288 nm，柱温30℃。结果高三尖杉酯碱在2~30μg的范围内与峰面积呈良好的线性关系，r=0.9996；以高三尖杉酯碱进样量为20μg重复进样6次，杂质A、杂质B、高三尖杉酯碱的RSD分别为3.28%，4.69%，1.12%。结论应用本方法精确可以测定高三尖杉酯碱中杂质A、杂质B等有关物质的量及高三尖杉酯碱的含量。
목적：건립RP-HPLC측정고삼첨삼지감급기제제유관물질적방법，병용기분석불동처리후고삼첨삼지감유관물질적량。방법채용Germsil-P C18색보주（250×4.6 mm，5μm），이10 mmol·L-1린산이경갑용액위류동상A，갑순위류동상B，제도세탈，류속1 mL·min-1，검측파장288 nm，주온30℃。결과고삼첨삼지감재2~30μg적범위내여봉면적정량호적선성관계，r=0.9996；이고삼첨삼지감진양량위20μg중복진양6차，잡질A、잡질B、고삼첨삼지감적RSD분별위3.28%，4.69%，1.12%。결론응용본방법정학가이측정고삼첨삼지감중잡질A、잡질B등유관물질적량급고삼첨삼지감적함량。
Objective To build up RP-HPLC method for measuring homobarringtonie and related substances of its preparations, and to analyze the content of homobarringtonie related substances after different treatment. Methods Apply Germsil-P C18 chromatographic column (250×4.6 mm, 5μm)and use 10 mmol·L-1 monopotassium phosphate as flow phase A while methanol as B. Apply gradient elution with the flow rate 1 mL·min-1, check the wavelength 288 nm with column temperature at 30 ℃. Results Homobarringtonie presented great linear relationship with peak area in the range of 2~30μg, with r=0.9996;when loading 20μg homobarringtonie in 6 repeats, impurity A, impurity B, and homobarringtonie RSD were 3.28%, 4.69%, and 1.12%, respectively. Conclusion Applying this method can precisely measure the content of homobarringtonie, and related substances, such as impurity A and impurity B.