高效液相色谱法测定枸橼酸氯米芬片中枸橼酸氯米芬
李佩濂,姬文英
榆林市药品检验所,陕西榆林 719000
Determination of clomiphene citrate content in clomiphene citrate tablet by high performance liquid chromatography
李佩濂,姬文英
Yulin Institute for Drug Control, Yulin 719000, China
摘要:建立高效液相色谱法测定枸橼酸氯米芬片中枸橼酸氯米芬含量的分析方法。以Waters C柱(25建立高效液相色谱法测定枸橼酸氯米芬片中枸橼酸氯米芬含量的分析方法。以Waters C柱(25 18cm×4.6 mm, 4.5μm)为色谱柱,流动相为甲醇-水(体积比为55∶45,用磷酸调节pH至2.5),流量为1.0 mL/min,检测波长为233 nm,柱温为30℃,进样体积为50μL。枸橼酸氯米芬在质量浓度为0.02~0.10 mg/mL的范围内与色谱峰峰面积线性关系良好,相关系数为0.999 5。样品测定结果的相对标准偏差为0.69%(n=6),加标回收率为98.0%~102.5%。该方法操作简便,专属性良好,适用于枸橼酸氯米芬片的质量控制。
Abstract:The method for the determination of clomiphene citrate content in clomiphene citrate tablet by high The method for the determination of clomiphene citrate content in clomiphene citrate tablet by high performance liquid chromatography was establshed. Waters C column (25 cm×4.6 mm, 4.5μm) was used as 18 chromatography column, methyl alcohol-water solution (volume ratio was 55∶45, phosphoric acid was used to adjust pH at 2.5) was used as the mobile phase with the flow rate of 1.0 mL/min, the detection wavelength was 233 nm, the column temperature was 30℃, and the injection volume was 50μL. The chromatograph peak area of clomiphene had better linear relation with the mass concentration in the range of 0.02-0.10 mg/mL with the correlation coefficent of 0.999 5. The relative standard deviation of the results was 0.69%(n=6), and the standard addition recoveries were 98.0%-102.5%. This method was simple and reliable for quality control of clomiphene citrate tablet.
关键词:高效液相色谱法;枸橼酸氯米芬;含量测定;片剂
Keywords:high performance liquid chromatography; clomiphene citrate; content determination; tablet
本文引用格式:
李佩濂,姬文英.高效液相色谱法测定枸橼酸氯米芬片中枸橼酸氯米芬[J].化学分析计量,2021,30(12):47.Li Peilian,Ji Wenying. Determination of clomiphene citrate content in clomiphene citrate tablet by high performance liquid chromatography[J]. Chemical Analysis and Meterage,2021,30(12):47.
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