CAJ | 학술논문

目的：建立用HPLC法测定聚甲酚磺醛栓剂中四种相关物质的含量。方法色谱柱为Diamonsil C18柱（150mm×4.6mm，5μm），检测波长为265nm，流动相为1%的乙酸铵溶液∶甲醇（90∶10）条件下测定m-甲酚-4，6-二磺酸铵、m-甲酚-4-磺酸铵，m-甲酚-6-磺酸铵；在检测波长为280nm，以1%的乙酸铵溶液：甲醇（70∶30）为流动相下聚甲酚磺醛二聚体铵，流速均为1.0mL/min，进样量5μL，柱温30℃。结果间甲酚-4，6-二磺酸铵、间甲酚-4-磺酸铵、间甲酚-6-磺酸铵与聚甲酚磺醛二聚体铵分别在0.0402~0.9636μg、0.0567~1.3608μg、0.0526~1.2624μg、0.0572~1.143μg范围内线性关系良好。间甲酚-4，6-二磺酸铵的线性方程为：Y=89806X+615， r=0.9999；间甲酚-4-磺酸铵的线性方程为：Y=112889X+1798，r=0.9997；间甲酚-6-磺酸铵的线性方程为：Y=136254X-2164，r=0.9997；聚甲酚磺醛二聚体铵线性方程为Y=259112X-3650，r=0.9994。各组分精密度，稳定性，重复性和回收率RSD均＜3%。结论该法准确性和重复性好，可用于聚甲酚磺醛栓剂的质量控制。
목적：건립용HPLC법측정취갑분광철전제중사충상관물질적함량。방법색보주위Diamonsil C18주（150mm×4.6mm，5μm），검측파장위265nm，류동상위1%적을산안용액∶갑순（90∶10）조건하측정m-갑분-4，6-이광산안、m-갑분-4-광산안，m-갑분-6-광산안；재검측파장위280nm，이1%적을산안용액：갑순（70∶30）위류동상하취갑분광철이취체안，류속균위1.0mL/min，진양량5μL，주온30℃。결과간갑분-4，6-이광산안、간갑분-4-광산안、간갑분-6-광산안여취갑분광철이취체안분별재0.0402~0.9636μg、0.0567~1.3608μg、0.0526~1.2624μg、0.0572~1.143μg범위내선성관계량호。간갑분-4，6-이광산안적선성방정위：Y=89806X+615， r=0.9999；간갑분-4-광산안적선성방정위：Y=112889X+1798，r=0.9997；간갑분-6-광산안적선성방정위：Y=136254X-2164，r=0.9997；취갑분광철이취체안선성방정위Y=259112X-3650，r=0.9994。각조분정밀도，은정성，중복성화회수솔RSD균＜3%。결론해법준학성화중복성호，가용우취갑분광철전제적질량공제。
Objective To develop an HPLC method for the content determination of determination of four components in policresulen vaginal suppositories. Methods Using high performance liquid chromatography (HPLC) method, a Diamonsil C18(150mm×4.6mm,5μm)column was used , with 1%ammonium acetate solution-methanol (90∶10) and 1%ammonium acetate solution-methanol (70∶30) as mobile phase. The mobile phase flow rate was 1.0 mL/min. The detector wavelength was set at 265nm and 280nm the column temperature was 30℃. Results Four kinds of composition content curve was linear over the range of 0.0402-0.9636μg, 0.0567-1.3608μg, 0.0526-1.2624μg, 0.0572-1.143μg (r=0.9999,r=0.9997,r=0.9997,r=0.9994). Stability, repeatability and recovery of Components RSD are less than 3%. Conclusion The proposed method is convenient, economical and accurate with good reproducibility, and can be used to evaluate the quality of policresulen vaginal suppositories.