首页|HPLC法测定愈创甘油醚有关物质

HPLC法测定愈创甘油醚有关物质

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目的 建立测定愈创甘油醚原料药有关物质的高效液相色谱法。方法 色谱柱为Agilent ZORBAX SB C18柱(250 mm×4。6 mm，5 μm)，流动相为水-乙腈(梯度洗脱)，流速为1。0 mL·min-1，检测波长为273 nm，柱温为30℃，进样量为10 μL。结果 愈创甘油醚峰与其杂质峰均能良好分离。杂质A、杂质B、杂质C和杂质D的各质量浓度与峰面积的线性关系良好(r≥0。999 7)，平均加样回收率分别为98。29%、101。35%、101。81%、101。05%，RSD值分别为1。02%、0。65%、2。83%、0。90%(n=9)。结论 该方法专属性强、准确度高，可用于愈创甘油醚原料药有关物质的测定，为国内愈创甘油醚原料药质量的提升提供技术支撑。
Determination of related substances in guaifenesin by HPLC
Objective To establish an HPLC method for the determination of related substances in guaifenesin active pharmaceutical ingredient(API).Methods The chromatographic column was Agilent ZORBAX SB C18(250 mm×4.6 mm,5 μm),and the mobile phase was water-acetonitrile(gradient elution).The flow rate was 1.0 mL·min-1,the detection wavelength was 273 nm,the column temperature was 30℃,and the injection volume was 10 μL.Results The peaks of guaifenesin and its impurities were well separated.The linear relationships between the mass concentrations and peak areas of impurities A,B,C,and D were good(r≥0.999 7),and the average recoveries(n=9)were 98.29%,101.35%,101.81%and 101.05%,and the RSDs were 1.02%,0.65%,2.83%and 0.90%,respectively.Conclusion The method is specific and accurate,and could be used for the determination of related substances in guaifenesin API,providing technical support for the improvement of the quality of guaifenesin API in China.

guaifenesinrelated substancesquality controlHPLC

蔡锦雄、刘敏、李玉兰

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深圳市药品检验研究院,深圳药品质量标准研究重点实验室,国家药品监督管理局仿制药评价生物等效性研究重点实验室,深圳 518057

愈创甘油醚 有关物质 质量控制 高效液相色谱法

国家药典委员会国家药品标准提高项目

药典综[2019]35号

2024

10.3969/j.issn.1004-2407.2024.03.005

西北药学杂志
西安交通大学,陕西省药学会

西北药学杂志

CSTPCD
影响因子：0.912
ISSN：1004-2407
年,卷(期)：2024.39(3)
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