摘要
通过建立如下RP-HPLC法来测定双醋瑞因原料药含量及有关物质,以高纯水用磷酸调pH值至2.0为流动相A,甲醇为流动相B,梯度洗脱,流速为1.0mL/min,柱温为40℃,检测波长为254nm,进样量为20μL;测定结果为各相邻峰的分离度均大于2.0,LOQ浓度为2.13×10-5mg/mL,线性方程为Y=-120.12X+107.48,r为0.9996(n=5);故本RP-HPLC法对双醋瑞因原料药含量及有关物质的测定是适用的,且专属性强,结果准确。
To establish the following RP - HPLC method to determine the Assay and Related Substances of API of Diacerein. Mobile phase A was water adjusted to pH 2.0 with phosphoric acid, mobile phase B was methanol, gradient elution,the flow rate was 1.0mL/min, the temperature of column was 40℃, the detection wavelength was at 254nm with injection volume of 20μL. The determination results as follow： all of the resolution of the nearby peaks were not less than 2.0, the LOQ was 2.13 × 10 - 5mg/mL, the linear equation was Y = - 120.12X ＋ 107.48, r = 0.9996 （n = 5）. Consequently this RP - HPLC method was good for the determination of Assay and Related Substances of API of Diaeerein, specific and accurate.
出处
《山东化工》
CAS
2013年第6期41-42,共2页
Shandong Chemical Industry
