加校正因子的主成分自身对照法测定复方片剂中瑞格列奈有关物质
发布时间：2018-11-14 15:01
【摘要】：目的:建立加校正因子的主成分自身对照法测定瑞格列奈盐酸二甲双胍片中瑞格列奈有关物质的含量。方法:采用JK Wp H C18色谱柱(4.6 mm×250 mm,5μm),以30 mmol·L-1磷酸二氢钾溶液(用磷酸调节p H至3.2)-乙腈为流动相,梯度洗脱,流速1.5 m L·min-1,检测波长240 nm,柱温40℃,进样量20μL。测定瑞格列奈和杂质A、B、C的线性方程,以斜率计算杂质相对于瑞格列奈的校正因子,用相对保留时间确定各杂质位置。并进行了方法学验证。用相对校正因子计算复方片剂中瑞格列奈杂质A、B、C的含量,并与杂质对照品法测得的结果进行比较。结果:瑞格列奈杂质A、B、C的相对保留时间分别为0.10、0.35、0.48,校正因子分别为0.65、0.76、3.06。检出限分别为0.27、0.12、4.21 ng,定量限分别为0.8、0.4、12.2 ng。采用校正因子的主成分自身对照法和外标法测得的结果无显著性差异。结论:本方法经方法验证,可准确测定复方片剂中瑞格列奈3种杂质的含量。
[Abstract]:Objective: to establish a principal component self-control method for the determination of related substances in reaglinide hydrochloride metformin hydrochloride tablets. Methods: JK Wp H C18 column (4.6 mm 脳 250 mm,5 渭 m),) was used with 30 mmol L-1 potassium dihydrogen phosphate solution (adjusted with phosphoric acid to adjust pH to 3.2) -acetonitrile as mobile phase, gradient elution, flow rate 1.5 mL min-1,. The detection wavelength is 240 nm, the column temperature is 40 鈩，
本文编号：2331506
[Abstract]:Objective: to establish a principal component self-control method for the determination of related substances in reaglinide hydrochloride metformin hydrochloride tablets. Methods: JK Wp H C18 column (4.6 mm 脳 250 mm,5 渭 m),) was used with 30 mmol L-1 potassium dihydrogen phosphate solution (adjusted with phosphoric acid to adjust pH to 3.2) -acetonitrile as mobile phase, gradient elution, flow rate 1.5 mL min-1,. The detection wavelength is 240 nm, the column temperature is 40 鈩，
本文编号：2331506
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